Examples of Basic Requirements of a Prima Facie Case of Obviousness

[Editor Note: This MPEP section is applicable regardless of whether an application

is examined under the AIA or under pre-AIA law. For applications subject to the first

inventor to file (FITF) provisions of the AIA, the relevant time is "before the

effective filing date of the claimed invention". For applications subject to

pre-AIA 35 U.S.C.

102

, the relevant time is "at the time of the invention". See

MPEP §

2150

et seq. Many of the court decisions discussed in this

section involved applications or patents subject to

pre-AIA 35 U.S.C. 102

. These court

decisions may be applicable to applications and patents subject to

AIA 35 U.S.C.

102

but the relevant time is before the effective filing date of

the claimed invention and not at the time of the invention.]

The Supreme Court in

KSR Int'l Co. v. Teleflex Inc.,

550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to

support a conclusion of obviousness which are consistent with the proper “functional

approach” to the determination of obviousness as laid down in

Graham

.

The key to supporting any rejection under

35 U.S.C. 103

is the clear articulation

of the reason(s) why the claimed invention would have been obvious. The Supreme Court in

KSR

noted that the analysis supporting a rejection under

35 U.S.C.

103

should be made explicit. In

Ball Aerosol v. Ltd.

Brands,

555 F.3d 984, 89 USPQ2d 1870 (Fed. Cir. 2009), the Federal Circuit

offered additional instruction as to the need for an explicit analysis. The Federal Circuit

explained that the Supreme Court’s requirement for an explicit analysis does not require

record evidence of an explicit teaching of a motivation to combine in the prior art.

“[T]he analysis that “should be made explicit” refers not

to the teachings in the prior art of a motivation to combine, but to the court’s analysis.

. .

instruction as to the need for an explicit analysis. The Federal Circuit

explained that the Supreme Court’s requirement for an explicit analysis does not require

record evidence of an explicit teaching of a motivation to combine in the prior art.

“[T]he analysis that “should be made explicit” refers not

to the teachings in the prior art of a motivation to combine, but to the court’s analysis.

. . . Under the flexible inquiry set forth by the Supreme Court, the district court

therefore erred by failing to take account of ‘the inferences and creative steps,’ or even

routine steps, that an inventor would employ and by failing to find a motivation to combine

related pieces from the prior art.”

Ball Aerosol,

555 F.3d at 993, 89

USPQ2d at 1877.

The Federal Circuit’s directive in

Ball

Aerosol

was addressed to a lower court, but it applies to Office personnel as

well. When setting forth a rejection, Office personnel are to continue to make appropriate

findings of fact as explained in

MPEP § 2141

and

§ 2143

, and must provide

a reasoned explanation as to why the invention as claimed would have been obvious to a

person of ordinary skill in the art at the relevant time. This requirement for explanation

remains even in situations in which Office personnel may properly rely on common sense or

ordinary ingenuity.

In re Van Os,

844 F.3d 1359, 1361, 121 USPQ2d 1209,

1211 (Fed. Cir. 2017) (“Absent some articulated rationale, a finding that a combination of

prior art would have been ‘common sense’ or ‘intuitive’ is no different than merely stating

the combination ‘would have been obvious.’”).

I

anation

remains even in situations in which Office personnel may properly rely on common sense or

ordinary ingenuity.

In re Van Os,

844 F.3d 1359, 1361, 121 USPQ2d 1209,

1211 (Fed. Cir. 2017) (“Absent some articulated rationale, a finding that a combination of

prior art would have been ‘common sense’ or ‘intuitive’ is no different than merely stating

the combination ‘would have been obvious.’”).

I.

EXAMPLES OF RATIONALES

Examples of rationales that may support a conclusion of obviousness

include:

(A) Combining prior art elements according to known methods to yield

predictable results;

(B) Simple substitution of one known element for another to obtain

predictable results;

(C) Use of known technique to improve similar devices (methods, or

products) in the same way;

(D) Applying a known technique to a known device (method, or product)

ready for improvement to yield predictable results;

(E) “Obvious to try” – choosing from a finite number of identified,

predictable solutions, with a reasonable expectation of success;

(F) Known work in one field of endeavor may prompt variations of it

for use in either the same field or a different one based on design incentives or

other market forces if the variations are predictable to one of ordinary skill in

the art;

(G) Some teaching, suggestion, or motivation in the prior art that

would have led one of ordinary skill to modify the prior art reference or to

combine prior art reference teachings to arrive at the claimed invention.

Note that the list of rationales provided is not intended to be an

all-inclusive list. Other rationales to support a conclusion of obviousness may be

relied upon by Office personnel. Any rationale employed must provide a link between the

factual findings and the legal conclusion of obviousness

y the prior art reference or to

combine prior art reference teachings to arrive at the claimed invention.

Note that the list of rationales provided is not intended to be an

all-inclusive list. Other rationales to support a conclusion of obviousness may be

relied upon by Office personnel. Any rationale employed must provide a link between the

factual findings and the legal conclusion of obviousness.

It is important for Office personnel to recognize that

when they do choose to formulate an obviousness rejection using one of the rationales

suggested by the Supreme Court in

KSR

and discussed herein, they are

to adhere to the guidance provided regarding the necessary factual findings. It remains

Office policy that appropriate factual findings are required in order to apply the

enumerated rationales properly.

The subsections below include discussions of each rationale along with

examples illustrating how the cited rationales may be used to support a finding of

obviousness. Some examples use the facts of pre-

KSR

cases to show how

the rationales suggested by the Court in

KSR

may be used to support a

finding of obviousness. The cases cited (from which the facts were derived) may not

necessarily stand for the proposition that the particular rationale is the basis for the

court’s holding of obviousness, but they do illustrate consistency of past decisions

with the lines of reasoning laid out in

KSR.

Other examples are

post-

KSR

decisions that show how the Federal Circuit has applied

the principles of

KSR.

Cases are included that illustrate findings of

obviousness as well as nonobviousness. Note that, in some instances, a single case is

used in different subsections to illustrate the use of more than one rationale to

support a finding of obviousness. It will often be the case that, once the

Graham

inquiries have been satisfactorily resolved, a conclusion

of obviousness may be supported by more than one line of reasoning.

A

illustrate findings of

obviousness as well as nonobviousness. Note that, in some instances, a single case is

used in different subsections to illustrate the use of more than one rationale to

support a finding of obviousness. It will often be the case that, once the

Graham

inquiries have been satisfactorily resolved, a conclusion

of obviousness may be supported by more than one line of reasoning.

A.

Combining Prior Art Elements According to Known Methods To Yield

Predictable Results

To reject a claim based on this rationale, Office personnel must

resolve the

Graham

factual inquiries. Then, Office personnel must

articulate the following:

(1) a finding that the prior art included each element claimed,

although not necessarily in a single prior art reference, with the only

difference between the claimed invention and the prior art being the lack of

actual combination of the elements in a single prior art reference;

(2) a finding that one of ordinary skill in the art could have

combined the elements as claimed by known methods, and that in combination,

each element merely performs the same function as it does separately;

(3) a finding that one of ordinary skill in the art would have

recognized that the results of the combination were predictable; and

(4) whatever additional findings based on the

Graham

factual inquiries may be necessary, in view of the

facts of the case under consideration, to explain a conclusion of obviousness.

The rationale to support a conclusion that the claim would have

been obvious is that all the claimed elements were known in the prior art and one

skilled in the art could have combined the elements as claimed by known methods with

no change in their respective functions, and the combination yielded nothing more

than predictable results to one of ordinary skill in the art.

KSR,

550 U.S. at 416, 82 USPQ2d at 1395;

B/E Aerospace, Inc. v. C&D Zodiac,

Inc.,

962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020);

Sakraida v. AG Pro, Inc.,

425 U.S. 273, 282, 189 USPQ 449, 453

combined the elements as claimed by known methods with

no change in their respective functions, and the combination yielded nothing more

than predictable results to one of ordinary skill in the art.

KSR,

550 U.S. at 416, 82 USPQ2d at 1395;

B/E Aerospace, Inc. v. C&D Zodiac,

Inc.,

962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020);

Sakraida v. AG Pro, Inc.,

425 U.S. 273, 282, 189 USPQ 449, 453

(1976);

Anderson’s-Black Rock, Inc. v. Pavement Salvage Co.,

396

U.S. 57, 62-63, 163 USPQ 673, 675 (1969);

Great Atl. & P. Tea Co. v.

Supermarket Equip. Corp.,

340 U.S. 147, 152, 87 USPQ 303, 306 (1950).

“[I]t 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.”

KSR,

550 U.S. at 418, 82 USPQ2d at 1396. If

any of these findings cannot be made, then this rationale cannot be used to support a

conclusion that the claim would have been obvious to one of ordinary skill in the

art.

Example 1:

The claimed invention in

Anderson’s-Black Rock, Inc. v.

Pavement Salvage Co.,

396 U.S. 57, 163 USPQ 673 (1969) was a paving

machine which combined several well-known elements onto a single chassis. Standard

prior art paving machines typically combined equipment for spreading and shaping

asphalt onto a single chassis. The patent claim included the well-known element of

a radiant-heat burner attached to the side of the paver for the purpose of

preventing cold joints during continuous strip paving. The prior art used radiant

heat for softening the asphalt to make patches, but did not use radiant heat

burners to achieve continuous strip paving. All of the component parts were known

in the prior art. The only difference was the combination of the “old elements”

into a single device by mounting them on a single chassis

er for the purpose of

preventing cold joints during continuous strip paving. The prior art used radiant

heat for softening the asphalt to make patches, but did not use radiant heat

burners to achieve continuous strip paving. All of the component parts were known

in the prior art. The only difference was the combination of the “old elements”

into a single device by mounting them on a single chassis. The Court found that

the operation of the heater was in no way dependent on the operation of the other

equipment, and that a separate heater could also be used in conjunction with a

standard paving machine to achieve the same results. The Court concluded that

“[t]he convenience of putting the burner together with the other elements in one

machine, though perhaps a matter of great convenience, did not produce a ‘new’ or

‘different function’” and that to those skilled in the art the use of the old

elements in combination would have been obvious.

Id.

at 60, 163

USPQ at 674.

Note that combining known prior art elements is not sufficient to

render the claimed invention obvious if the results would not have been

predictable to one of ordinary skill in the art.

United States v.

Adams,

383 U.S. 39, 51-52, 148 USPQ 479, 483-84 (1966). In

Adams,

the claimed invention was to a battery with one

magnesium electrode and one cuprous chloride electrode that could be stored dry

and activated by the addition of plain water or salt water. Although magnesium and

cuprous chloride were individually known battery components, the Court concluded

that the claimed battery was nonobvious. The Court stated that “[d]espite the fact

that each of the elements of the Adams battery was well known in the prior art, to

combine them as did Adams required that a person reasonably skilled in the prior

art must ignore” the teaching away of the prior art that such batteries were

impractical and that water-activated batteries were successful only when combined

with electrolytes detrimental to the use of magnesium electrodes.

Id

the fact

that each of the elements of the Adams battery was well known in the prior art, to

combine them as did Adams required that a person reasonably skilled in the prior

art must ignore” the teaching away of the prior art that such batteries were

impractical and that water-activated batteries were successful only when combined

with electrolytes detrimental to the use of magnesium electrodes.

Id.

at 42-43, 50-52, 148 USPQ at 480, 483. “[W]hen the prior

art teaches away from combining certain known elements, discovery of successful

means of combining them is more likely to be nonobvious.”

KSR,

550 U.S. at 416, 82 USPQ2d at 1395.

Example 2:

The claimed invention in

Ruiz v. A.B. Chance

Co.,

357 F.3d 1270, 69 USPQ2d 1686 (Fed. Cir. 2004) was directed to a

system which employs a

screw anchor

for underpinning

existing foundations and a

metal bracket

to transfer the

building load onto the screw anchor. The prior art (Fuller) used screw anchors for

underpinning existing structural foundations. Fuller used a concrete haunch to

transfer the load of the foundation to the screw anchor. The prior art (Gregory)

used a push pier for underpinning existing structural foundations. Gregory taught

a method of transferring load using a bracket, wherein a metal bracket transfers

the foundation load to the push pier. The pier is driven into the ground to

support the load. Neither reference showed the two elements of the claimed

invention – screw anchor and metal bracket – used together. The court found that

“artisans knew that a foundation underpinning system requires a means of

connecting the foundation to the load-bearing member.”

Id.

at

1276, 69 USPQ2d at 1691.

The nature of the problem to be solved – underpinning unstable

foundations – as well as the need to connect the member to the foundation to

accomplish this goal, would have led one of ordinary skill in the art to choose an

appropriate load bearing member and a compatible attachment

ing system requires a means of

connecting the foundation to the load-bearing member.”

Id.

at

1276, 69 USPQ2d at 1691.

The nature of the problem to be solved – underpinning unstable

foundations – as well as the need to connect the member to the foundation to

accomplish this goal, would have led one of ordinary skill in the art to choose an

appropriate load bearing member and a compatible attachment. Therefore, it would

have been obvious to use a metal bracket (as shown in Gregory) in combination with

the screw anchor (as shown in Fuller) to underpin unstable foundations.

Example 3:

The case of

In re Omeprazole Patent

Litigation,

536 F.3d 1361, 87 USPQ2d 1865 (Fed. Cir. 2008), is one in

which the claims in question were found to be nonobvious in the context of an

argument to combine prior art elements. The invention involved applying enteric

coatings to a drug in pill form for the purpose of ensuring that the drug did not

disintegrate before reaching its intended site of action. The drug at issue was

omeprazole, the generic name for gastric acid inhibitor marketed as

Prilosec

®

. The claimed formulation included two

layers of coatings over the active ingredient.

The district court found that Astra’s patent in

suit was infringed by defendants Apotex and Impax. The district court rejected

Apotex’s defense that the patents were invalid for obviousness. Apotex had argued

that the claimed invention was obvious because coated omeprazole tablets were

known from a prior art reference, and because secondary subcoatings in

pharmaceutical preparations generally were also known. There was no evidence of

unpredictability associated with applying two different enteric coatings to

omeprazole. However, Astra’s reason for applying an intervening subcoating between

the prior art coating and omeprazole had been that the prior art coating was

actually interacting with omeprazole, thereby contributing to undesirable

degradation of the active ingredient

s generally were also known. There was no evidence of

unpredictability associated with applying two different enteric coatings to

omeprazole. However, Astra’s reason for applying an intervening subcoating between

the prior art coating and omeprazole had been that the prior art coating was

actually interacting with omeprazole, thereby contributing to undesirable

degradation of the active ingredient. This degradation of omeprazole by

interaction with the prior art coating had not been recognized in the prior art.

Therefore, the district court reasoned that based on the evidence available, a

person of ordinary skill in the art would have had no reason to include a

subcoating in an omeprazole pill formulation.

The Federal Circuit affirmed the district court’s

decision that the claimed invention was not obvious. Even though subcoatings for

enteric drug formulation were known, and there was no evidence of undue technical

hurdles or lack of a reasonable expectation of success, the formulation was

nevertheless not obvious because the flaws in the prior art formulation that had

prompted the modification had not been recognized. Thus there would have been no

reason to modify the initial formulation, even though the modification could have

been done. Moreover, a person of ordinary skill in the art likely would have

chosen a different modification even if they had recognized the problem.

Office personnel should note that in this case the

modification of the prior art that had been presented as an argument for

obviousness was an extra process step that added an additional component to a

known, successfully marketed formulation. The proposed modification thus amounted

to extra work and greater expense for no apparent reason. This is not the same as

combining known prior art elements A and B when each would have been expected to

contribute its own known properties to the final product

d as an argument for

obviousness was an extra process step that added an additional component to a

known, successfully marketed formulation. The proposed modification thus amounted

to extra work and greater expense for no apparent reason. This is not the same as

combining known prior art elements A and B when each would have been expected to

contribute its own known properties to the final product. In the

Omeprazole

case, in view of the expectations of those of

ordinary skill in the art, adding the subcoating would not have been expected to

confer any particular desirable property on the final product. Rather, the final

product obtained according to the proposed modifications would merely have been

expected to have the same functional properties as the prior art product.

The

Omeprazole

case can also be

analyzed in view of the discovery of a previously unknown problem by the patentee.

If the adverse interaction between active agent and coating had been known, it

might well have been obvious to use a subcoating. However, since the problem had

not been previously known, there would have been no reason to incur additional

time and expense to add another layer, even though the addition would have been

technologically possible. This is true because the prior art of record failed to

mention any stability problem, despite the acknowledgment during testimony at

trial that there was a known theoretical reason that omeprazole might be subject

to degradation in the presence of the known coating material.

Example 4:

The case of

Crocs, Inc. v. U.S. Int'l

Trade Comm'n,

598 F.3d 1294, 93 USPQ 1777 (Fed. Cir. 2010), is a

decision in which the claimed foam footwear was held by the Federal Circuit to be

nonobvious over a combination of prior art references.

The claims involved in the obviousness issue were

from Crocs’ U.S. Patent No. 6,993,858, and were drawn to footwear in which a

one-piece molded foam base section formed the top of the shoe (the upper) and the

sole

98 F.3d 1294, 93 USPQ 1777 (Fed. Cir. 2010), is a

decision in which the claimed foam footwear was held by the Federal Circuit to be

nonobvious over a combination of prior art references.

The claims involved in the obviousness issue were

from Crocs’ U.S. Patent No. 6,993,858, and were drawn to footwear in which a

one-piece molded foam base section formed the top of the shoe (the upper) and the

sole. A strap also made of foam was attached to the foot opening of the upper,

such that the strap could provide support to the Achilles portion of the wearer’s

foot. The strap was attached via connectors that allowed it to be in contact with

the base section, and to pivot relative to the base section. Because both the base

portion and the strap were made of foam, friction between the strap and the base

section allowed the strap to maintain its position after pivoting. In other words,

the foam strap did not fall under the force of gravity to a position adjacent to

the heel of the base section.

The International Trade Commission (ITC) determined

that the claims were obvious over the combination of two pieces of prior art. The

first was the Aqua Clog, which was a shoe that corresponded to the base section of

the footwear of the ‘858 patent. The second was the Aguerre patent, which taught

heel straps made of elastic or another flexible material. In the ITC’s view, the

claimed invention was obvious because the prior art Aqua Clog differed from the

claimed invention only as to the presence of the strap, and a suitable strap was

taught by Aguerre.

The Federal Circuit disagreed. The Federal Circuit

stated that the prior art did not teach foam heel straps, or that a foam heel

strap should be placed in contact with a foam base. The Federal Circuit pointed

out that the prior art actually counseled against using foam as a material for the

heel strap of a shoe.

The record shows that the prior art would

actually discourage and teach away from the use of foam straps

t disagreed. The Federal Circuit

stated that the prior art did not teach foam heel straps, or that a foam heel

strap should be placed in contact with a foam base. The Federal Circuit pointed

out that the prior art actually counseled against using foam as a material for the

heel strap of a shoe.

The record shows that the prior art would

actually discourage and teach away from the use of foam straps. An ordinary

artisan in this field would not add a foam strap to the foam Aqua Clog because

foam was likely to stretch and deform, in addition to causing discomfort for a

wearer. The prior art depicts foam as unsuitable for straps.

Id.

at 1309, 93 USPQ2d at 1787-88.

The Federal Circuit continued, stating that even if

– contrary to fact – the claimed invention had been a combination of elements that

were known in the prior art, the claims still would have been nonobvious. There

was testimony in the record that the loose fit of the heel strap made the shoe

more comfortable for the wearer than prior art shoes in which the heel strap was

constantly in contact with the wearer’s foot. In the claimed footwear, the foam

heel strap contacted the wearer’s foot only when needed to help reposition the

foot properly in the shoe, thus reducing wearer discomfort that could arise from

constant contact. This desirable feature was a result of the friction between the

base section and the strap that kept the strap in place behind the Achilles

portion of the wearer’s foot. The Federal Circuit pointed out that this

combination “yielded more than predictable results.”

Id.

at

1310, 93 USPQ2d at 1788. Aguerre had taught that friction between the base section

and the strap was a problem rather than an advantage, and had suggested the use of

nylon washers to reduce friction. Thus the Federal Circuit stated that even if all

elements of the claimed invention had been taught by the prior art, the claims

would not have been obvious because the combination yielded more than predictable

results

t 1788. Aguerre had taught that friction between the base section

and the strap was a problem rather than an advantage, and had suggested the use of

nylon washers to reduce friction. Thus the Federal Circuit stated that even if all

elements of the claimed invention had been taught by the prior art, the claims

would not have been obvious because the combination yielded more than predictable

results.

The Federal Circuit’s discussion in Crocs serves as

a reminder to Office personnel that merely pointing to the presence of all claim

elements in the prior art is not a complete statement of a rejection for

obviousness. In accordance with

MPEP § 2143

, subsection I.A.(3),

a proper rejection based on the rationale that the claimed invention is a

combination of prior art elements also includes a finding that results flowing

from the combination would have been predictable to a person of ordinary skill in

the art.

MPEP §

2143

, subsection I.A.(3). If results would not have been

predictable, Office personnel should not enter an obviousness rejection using the

combination of prior art elements rationale, and should withdraw such a rejection

if it has been made.

Example 5:

Sundance, Inc. v. DeMonte Fabricating Ltd.,

550 F.3d 1356, 89

USPQ2d 1535 (Fed. Cir. 2008), involved a segmented and mechanized cover for

trucks, swimming pools, or other structures. The claim was found to be obvious

over the prior art applied.

A first prior art reference taught that a reason

for making a segmented cover was ease of repair, in that a single damaged segment

could be readily removed and replaced when necessary. A second prior art reference

taught the advantages of a mechanized cover for ease of opening. The Federal

Circuit noted that the segmentation aspect of the first reference and the

mechanization function of the second perform in the same way after combination as

they had before

segmented cover was ease of repair, in that a single damaged segment

could be readily removed and replaced when necessary. A second prior art reference

taught the advantages of a mechanized cover for ease of opening. The Federal

Circuit noted that the segmentation aspect of the first reference and the

mechanization function of the second perform in the same way after combination as

they had before. The Federal Circuit further observed that a person of ordinary

skill in the art would have expected that adding replaceable segments as taught by

the first reference to the mechanized cover of the other would result in a cover

that maintained the advantageous properties of both of the prior art covers.

Thus, the Sundance case points out that a hallmark

of a proper obviousness rejection based on combining known prior art elements is

that one of ordinary skill in the art would reasonably have expected the elements

to maintain their respective properties or functions after they have been

combined.

Example 6:

In the case of

Ecolab, Inc. v. FMC

Corp.,

569 F.3d 1335, 91 USPQ2d 1225 (Fed. Cir. 2009), an “apparent

reason to combine” in conjunction with the technical ability to optimize led to

the conclusion that the claimed invention would have been obvious.

The invention in question was a method of treating

meat to reduce the incidence of pathogens, by spraying the meat with an

antibacterial solution under specified conditions. The parties did not dispute

that a single prior art reference had taught all of the elements of the claimed

invention, except for the pressure limitation of “at least 50 psi.”

FMC had argued at the district court that the

claimed invention would have been obvious in view of the first prior art reference

mentioned above in view of a second reference that had taught the advantages of

spray-treating at pressures of 20 to 150 psi when treating meat with a different

antibacterial agent

lements of the claimed

invention, except for the pressure limitation of “at least 50 psi.”

FMC had argued at the district court that the

claimed invention would have been obvious in view of the first prior art reference

mentioned above in view of a second reference that had taught the advantages of

spray-treating at pressures of 20 to 150 psi when treating meat with a different

antibacterial agent. The district court did not find FMC’s argument to be

convincing, and denied the motion for judgment as a matter of law that the claim

was obvious.

Disagreeing with the district court, the Federal

Circuit stated that “there was an apparent reason to combine these known elements

– namely to increase contact between the [antibacterial solution] and the bacteria

on the meat surface and to use the pressure to wash additional bacteria off the

meat surface.”

Id.

at 1350, 91 USPQ2d at 1234. The Federal

Circuit explained that because the second reference had taught “using high

pressure to improve the effectiveness of an antimicrobial solution when sprayed

onto meat, and because an ordinarily skilled artisan would have recognized the

reasons for applying [the claimed antibacterial solution] using high pressure and

would have known how to do so, Ecolab’s claims combining high pressure with other

limitations disclosed in FMC’s patent are invalid as obvious.”

Id.

When considering the question of obviousness,

Office personnel should keep in mind the capabilities of a person of ordinary

skill. In

Ecolab,

the Federal Circuit stated:

Ecolab’s expert admitted that one skilled in the

art would know how to adjust application parameters to determine the optimum

parameters for a particular solution. The question then is whether it would

have been obvious to combine the high pressure parameter disclosed in the

Bender patent with the PAA methods disclosed in FMC’s ’676 patent. The answer

is yes.

Id

Ecolab,

the Federal Circuit stated:

Ecolab’s expert admitted that one skilled in the

art would know how to adjust application parameters to determine the optimum

parameters for a particular solution. The question then is whether it would

have been obvious to combine the high pressure parameter disclosed in the

Bender patent with the PAA methods disclosed in FMC’s ’676 patent. The answer

is yes.

Id.

If optimization of the application parameters had

not been within the level of ordinary skill in the art, the outcome of the

Ecolab

case may well have been different.

Example 7:

In the case of

Wyers v. Master Lock

Co.,

616 F.3d 1231, 95 USPQ2d 1525 (Fed. Cir. 2010), the Federal

Circuit held that the claimed barbell-shaped hitch pin locks used to secure

trailers to vehicles were obvious.

The court discussed two different sets of claims in

Wyers,

both drawn to improvements over the prior art hitch

pin locks. The first improvement was a removable sleeve that could be placed over

the shank of the hitch pin lock so that the same lock could be used with towing

apertures of varying sizes. The second improvement was an external flat flange

seal adapted to protect the internal lock mechanism from contaminants. Wyers had

admitted that each of several prior art references taught every element of the

claimed inventions except for the removable sleeve and the external covering.

Master Lock had argued that these references, in combination with additional

references teaching the missing elements, would have rendered the claims obvious.

The court first addressed the question of whether the additional references relied

on by Master Lock were analogous prior art. As to the reference teaching the

sleeve improvement, the court concluded that it dealt specifically with using a

vehicle to tow a trailer, and was therefore in the same field of endeavor as

Wyers’ sleeve improvement. The reference teaching the sealing improvement dealt

with a padlock rather than a lock for a tow hitch

her the additional references relied

on by Master Lock were analogous prior art. As to the reference teaching the

sleeve improvement, the court concluded that it dealt specifically with using a

vehicle to tow a trailer, and was therefore in the same field of endeavor as

Wyers’ sleeve improvement. The reference teaching the sealing improvement dealt

with a padlock rather than a lock for a tow hitch. The court noted that Wyers’

specification had characterized the claimed invention as being in the field of

locking devices, thus at least suggesting that the sealed padlock reference was in

the same field of endeavor. However, the court also observed that even if sealed

padlocks were not in the same field of endeavor, they were nevertheless reasonably

pertinent to the problem of avoiding contamination of a locking mechanism for tow

hitches. The court explained that the Supreme Court’s decision in

KSR

“directs [it] to construe the scope of analogous art

broadly.”

Id.

at 1238, 95 USPQ2d at 1530. For these reasons,

the court found that Master Lock’s asserted references were analogous prior art,

and therefore relevant to the obviousness inquiry.

The court then turned to the question of whether

there would have been adequate motivation to combine the prior art elements as had

been urged by Master Lock. The court recalled the

Graham

inquiries, and also emphasized the “expansive and flexible” post-KSR approach to

obviousness that must not “deny factfinders recourse to common sense.”

Id.

at 1238, 95 USPQ2d at 1530-31. (quoting

KSR,

550 U.S. at 415, 421, 82 USPQ2d at 1395, 1397). The

court stated:

KSR

and our later cases establish that the legal

determination of obviousness may include recourse to logic, judgment, and

common sense, in lieu of expert testimony. . . . Thus, in appropriate cases,

the ultimate inference as to the existence of a motivation to combine

references may boil down to a question of “common sense,” appropriate for

resolution on summary judgment or JMOL.

Id

court stated:

KSR

and our later cases establish that the legal

determination of obviousness may include recourse to logic, judgment, and

common sense, in lieu of expert testimony. . . . Thus, in appropriate cases,

the ultimate inference as to the existence of a motivation to combine

references may boil down to a question of “common sense,” appropriate for

resolution on summary judgment or JMOL.

Id.

at 1240, 82 USPQ2d at 1531 (citing

Perfect Web

Techs., Inc. v. InfoUSA, Inc.,

587 F.3d 1324, 1330, 92 USPQ2d, 1849,

1854 (Fed. Cir. 2009);

Ball Aerosol,

555 F.3d at 993, 89 USPQ2d

1870, 1875 (Fed. Cir. 2009)).

After reviewing these principles, the court

proceeded to explain why adequate motivation to combine had been established in

this case. With regard to the sleeve improvement, it pointed out that the need for

different sizes of hitch pins was well known in the art, and that this was a known

source of inconvenience and expense for users. The court also mentioned the

marketplace aspect of the issue, noting that space on store shelves was at a

premium, and that removable sleeves addressed this economic concern. As to the

sealing improvement, the court pointed out that both internal and external seals

were well-known means to protect locks from contaminants. The court concluded that

the constituent elements were being employed in accordance with their recognized

functions, and would have predictably retained their respective functions when

combined as suggested by Master Lock. The court cited

In re

O’Farrell,

853 F.2d 894, 904 (Fed. Cir. 1988) for the proposition

that a reasonable expectation of success is a requirement for a proper

determination of obviousness.

Office personnel should note that although the

Federal Circuit invoked the idea of common sense in support of a conclusion of

obviousness, it did not end its explanation there

mbined as suggested by Master Lock. The court cited

In re

O’Farrell,

853 F.2d 894, 904 (Fed. Cir. 1988) for the proposition

that a reasonable expectation of success is a requirement for a proper

determination of obviousness.

Office personnel should note that although the

Federal Circuit invoked the idea of common sense in support of a conclusion of

obviousness, it did not end its explanation there. Rather, the court explained why

a person of ordinary skill in the art at the time of the invention, in view of the

facts relevant to the case, would have found the claimed inventions to have been

obvious. The key to supporting any rejection under

35 U.S.C.

103

is the clear articulation of the reason(s) why the

claimed invention would have been obvious. The Supreme Court in

KSR

noted that the analysis supporting a rejection under

35 U.S.C.

103

should be made explicit. The Court quoting

In

re Kahn,

441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006),

stated that “[R]ejections on obviousness 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.” See

MPEP §

2141

, subsection III. Office personnel should continue

to provide a reasoned explanation for every obviousness rejection.

Example 8:

The claim in

DePuy Spine, Inc. v.

Medtronic Sofamor Danek, Inc.,

567 F.3d 1314, 90 USPQ2d 1865 (Fed.

Cir. 2009), was directed to a polyaxial pedicle screw used in spinal surgeries

that included a compression member for pressing a screw head against a receiver

member. A prior art reference (Puno) disclosed all of the elements of the claim

except for the compression member. Instead, the screw head in Puno was separated

from the receiver member to achieve a shock absorber effect, allowing some motion

between receiver member and the vertebrae

icle screw used in spinal surgeries

that included a compression member for pressing a screw head against a receiver

member. A prior art reference (Puno) disclosed all of the elements of the claim

except for the compression member. Instead, the screw head in Puno was separated

from the receiver member to achieve a shock absorber effect, allowing some motion

between receiver member and the vertebrae. The missing compression member was

readily found in another prior art reference (Anderson), which disclosed an

external fracture immobilization splint for immobilizing long bones with a swivel

clamp capable of polyaxial movement until rigidly secured by a compression member.

It was asserted during trial that a person of ordinary skill would have recognized

that the addition of Anderson’s compression member to Puno’s device would have

achieved a rigidly locked polyaxial pedicle screw covered by the claim.

In conducting its analysis, the Federal Circuit

noted that the “predictable result” discussed in

KSR

refers not

only to the expectation that prior art elements are capable of being physically

combined, but also that the combination would have worked for its intended

purpose. In this case, it was successfully argued that Puno “teaches away” from a

rigid screw because Puno warned that rigidity increases the likelihood that the

screw will fail within the human body, rendering the device inoperative for its

intended purpose. In fact, the reference did not merely express a general

preference for pedicle screws having a “shock absorber” effect, but rather

expressed concern for failure and stated that the shock absorber feature

“decrease[s] the chance of failure of the screw of the bone-screw interface”

because “it prevent[s] direct transfer of load from the rod to the bone-screw

interface.” Thus, the alleged reason to combine the prior art elements of Puno and

Anderson—increasing the rigidity of the screw—ran contrary to the prior art that

taught that increasing rigidity would result in a greater likelihood of failure

e

“decrease[s] the chance of failure of the screw of the bone-screw interface”

because “it prevent[s] direct transfer of load from the rod to the bone-screw

interface.” Thus, the alleged reason to combine the prior art elements of Puno and

Anderson—increasing the rigidity of the screw—ran contrary to the prior art that

taught that increasing rigidity would result in a greater likelihood of failure.

In view of this teaching and the backdrop of collective teachings of the prior

art, the Federal Circuit determined that Puno teaches away from the proposed

combination such that a person of ordinary skill would have been deterred from

combining the references as proposed. Secondary considerations evaluated by the

Federal Circuit relating to failure by others and copying also supported the view

that the combination would not have been obvious at the time of the invention.

B.

Simple Substitution of One Known Element for Another To Obtain

Predictable Results

To reject a claim based on this rationale, Office personnel must

resolve the

Graham

factual inquiries. Then, Office personnel must

articulate the following:

(1) a finding that the prior art contained a device (method,

product, etc.) which differed from the claimed device by the substitution of

some components (step, element, etc.) with other components;

(2) a finding that the substituted components and their functions

were known in the art;

(3) a finding that one of ordinary skill in the art could have

substituted one known element for another, and the results of the substitution

would have been predictable; and

roduct, etc.) which differed from the claimed device by the substitution of

some components (step, element, etc.) with other components;

(2) a finding that the substituted components and their functions

were known in the art;

(3) a finding that one of ordinary skill in the art could have

substituted one known element for another, and the results of the substitution

would have been predictable; and

(4) whatever additional findings based on the

Graham

factual inquiries may be necessary, in view of the

facts of the case under consideration, to explain a conclusion of

obviousness.

The rationale to support a conclusion that the claim would have

been obvious is that the substitution of one known element for another yields

predictable results to one of ordinary skill in the art. If any of these findings

cannot be made, then this rationale cannot be used to support a conclusion that the

claim would have been obvious to one of ordinary skill in the art.

Example 1:

The claimed invention in

In re Fout,

675 F.2d

297, 213 USPQ 532 (CCPA 1982) was directed to a method for decaffeinating coffee

or tea. The prior art (Pagliaro) method produced a decaffeinated vegetable

material and trapped the caffeine in a fatty material (such as oil). The caffeine

was then removed from the fatty material by an aqueous extraction process.

Applicant (Fout) substituted an evaporative distillation step for the aqueous

extraction step. The prior art (Waterman) suspended coffee in oil and then

directly distilled the caffeine through the oil. The court found that “[b]ecause

both Pagliaro and Waterman teach a method for separating caffeine from oil, it

would have been

prima facie

obvious to substitute one method

for the other. Express suggestion to substitute one equivalent for another need

not be present to render such substitution obvious.”

Id.

at

301, 213 USPQ at 536.

Example 2:

The claimed invention in

In re O’Farrell,

853

F.2d 894, 7 USPQ2d 1673 (Fed. Cir

]ecause

both Pagliaro and Waterman teach a method for separating caffeine from oil, it

would have been

prima facie

obvious to substitute one method

for the other. Express suggestion to substitute one equivalent for another need

not be present to render such substitution obvious.”

Id.

at

301, 213 USPQ at 536.

Example 2:

The claimed invention in

In re O’Farrell,

853

F.2d 894, 7 USPQ2d 1673 (Fed. Cir. 1988) was directed to a method for synthesizing

a protein in a transformed bacterial host species by substituting a heterologous

gene for a gene native to the host species. Generally speaking, protein synthesis

in vivo

follows a path from DNA to mRNA. Although the prior

art Polisky article (authored by two of the three joint inventors of the

application) had explicitly suggested employing the method described for protein

synthesis, the inserted heterologous gene exemplified in the article was one that

normally did not proceed all the way to the protein production step, but instead

terminated with the mRNA. A second reference to Bahl had described a general

method of inserting chemically synthesized DNA into a plasmid. Thus, it would have

been obvious to one of ordinary skill in the art to replace the prior art gene

with another gene known to lead to protein production, because one of ordinary

skill in the art would have been able to carry out such a substitution, and the

results were reasonably predictable.

In response to applicant’s argument that there had been

significant unpredictability in the field of molecular biology at the time of the

invention, the court stated that the level of skill was quite high and that the

teachings of Polisky, even taken alone, contained detailed enabling methodology

and included the suggestion that the modification would be successful for

synthesis of proteins.

This is not a situation where the rejection is a statement that

it would have been “obvious to try” without more. Here there was a reasonable

expectation of success

stated that the level of skill was quite high and that the

teachings of Polisky, even taken alone, contained detailed enabling methodology

and included the suggestion that the modification would be successful for

synthesis of proteins.

This is not a situation where the rejection is a statement that

it would have been “obvious to try” without more. Here there was a reasonable

expectation of success. “Obviousness does not require absolute predictability of

success.”

Id.

at 903, 7 USPQ2d at 1681.

Example 3:

The fact pattern in

Ruiz v. AB Chance Co.,

357

F.3d 1270, 69 USPQ2d 1686 (Fed. Cir. 2004) is set forth above in Example 2 in

subsection I.A., above.

The prior art showed differing load-bearing members and differing

means of attaching the foundation to the member. Therefore, it would have been

obvious to one of ordinary skill in the art to substitute the metal bracket taught

in Gregory for Fuller’s concrete haunch for the predictable result of transferring

the load.

Example 4:

The claimed invention in

Ex parte Smith,

83

USPQ2d 1509 (Bd. Pat. App. & Int. 2007), was a pocket insert for a bound book

made by gluing a base sheet and a pocket sheet of paper together to form a

continuous two-ply seam defining a closed pocket. The prior art (Wyant) disclosed

at least one pocket formed by folding a single sheet and securing the folder

portions along the inside margins using any convenient bonding method. The prior

art (Wyant) did not disclose bonding the sheets to form a continuous two-ply seam.

The prior art (Dick) disclosed a pocket that is made by stitching or otherwise

securing two sheets along three of its four edges to define a closed pocket with

an opening along its fourth edge

ding a single sheet and securing the folder

portions along the inside margins using any convenient bonding method. The prior

art (Wyant) did not disclose bonding the sheets to form a continuous two-ply seam.

The prior art (Dick) disclosed a pocket that is made by stitching or otherwise

securing two sheets along three of its four edges to define a closed pocket with

an opening along its fourth edge.

In considering the teachings of Wyant and Dick, the Board “found

that (1) each of the claimed elements is found within the scope and content of the

prior art; (2) one of ordinary skill in the art could have combined the elements

as claimed by methods known at the time the invention was made; and (3) one of

ordinary skill in the art would have recognized at the time the invention was made

that the capabilities or functions of the combination were predictable.” Citing

KSR,

the Board concluded that “[t]he substitution of the

continuous, two-ply seam of Dick for the folded seam of Wyant thus is no more than

the simple substitution of one known element for another or the mere application

of a known technique to a piece of prior art ready for improvement.

Example 5:

The claimed invention in

In re ICON Health

& Fitness, Inc.,

496 F.3d 1374, 83 USPQ2d 1746 (Fed. Cir. 2007),

was directed to a treadmill with a folding tread base that swivels into an upright

storage position, including a gas spring connected between the tread base and the

upright structure to assist in stably retaining the tread base in the storage

position. On reexamination, the examiner rejected the claims as obvious based on a

combination of references including an advertisement (Damark) for a folding

treadmill demonstrating all of the claim elements other than the gas spring, and a

patent (Teague) with a gas spring

pring connected between the tread base and the

upright structure to assist in stably retaining the tread base in the storage

position. On reexamination, the examiner rejected the claims as obvious based on a

combination of references including an advertisement (Damark) for a folding

treadmill demonstrating all of the claim elements other than the gas spring, and a

patent (Teague) with a gas spring. Teague was directed to a bed that folds into a

cabinet using a novel dual-action spring that reverses force as the mechanism

passes a neutral position, rather than a single-action spring that would provide a

force pushing the bed closed at all times. The dual-action spring reduced the

force required to open the bed from the closed position, while reducing the force

required to lift the bed from the open position.

The Federal Circuit addressed the propriety of

making the combination since Teague was in a different field than the application.

Teague was found to be reasonably pertinent to the problem addressed in the

application because the folding mechanism did not require any particular focus on

treadmills, but rather generally addressed problems of supporting the weight of

such a mechanism and providing a stable resting position.

The court also considered whether one skilled in the

art would have been led to combine the teachings of Damark and Teague. Appellant

argued that Teague teaches away from the invention because it directs one skilled

in the art not to use single-action springs and does not satisfy the claim

limitations as the dual-action springs would render the invention inoperable. The

Federal Circuit considered these arguments and found that, while Teague at most

teaches away from using single-action springs to decrease the opening force, it

actually instructed that single-action springs provide the result desired by the

inventors, which was to increase the opening force provided by gravity

claim

limitations as the dual-action springs would render the invention inoperable. The

Federal Circuit considered these arguments and found that, while Teague at most

teaches away from using single-action springs to decrease the opening force, it

actually instructed that single-action springs provide the result desired by the

inventors, which was to increase the opening force provided by gravity. As to

inoperability, the claims were not limited to single-action springs and were so

broad as to encompass anything that assists in stably retaining the tread base,

which is the function that Teague accomplished. Additionally, the fact that the

counterweight mechanism from Teague used a large spring, which appellant argued

would overpower the treadmill mechanism, ignores the modifications that one

skilled in the art would make to a device borrowed from the prior art. One skilled

in the art would size the components from Teague appropriately for the

application.

ICON

is another useful example for understanding the scope of

analogous art. The art applied concerned retaining mechanisms for folding beds,

not treadmills. When determining whether a reference may properly be applied to an

invention in a different field of endeavor, it is necessary to consider the

problem to be solved. It is certainly possible that a reference may be drawn in

such a way that its usefulness as a teaching is narrowly restricted. However,

in

ICON,

the problem to be solved was not limited to the

teaching of the “treadmill” concept. The Teague reference was analogous art

because “Teague and the current application both address the need to stably retain

a folding mechanism,” and because “nothing about ICON’s folding mechanism requires

any particular focus on treadmills,”

Id.

at 1378, 1380, 83

USPQ2d at 1749-50.

ICON

is also informative as to the relationship between the

problem to be solved and existence of a reason to combine

The Teague reference was analogous art

because “Teague and the current application both address the need to stably retain

a folding mechanism,” and because “nothing about ICON’s folding mechanism requires

any particular focus on treadmills,”

Id.

at 1378, 1380, 83

USPQ2d at 1749-50.

ICON

is also informative as to the relationship between the

problem to be solved and existence of a reason to combine. “Indeed, while perhaps

not dispositive of the issue, the finding that Teague, by addressing a similar

problem, provides analogous art to ICON’s application goes a long way towards

demonstrating a reason to combine the two references. Because ICON’s broad claims

read on embodiments addressing that problem as described by Teague, the prior art

here indicates a reason to incorporate its teachings.”

Id.

at

1380-81, 83 USPQ2d at 1751.

The Federal Circuit’s discussion in

ICON

also makes clear that if the reference does not teach

that a combination is undesirable, then it cannot be said to teach away. An

assessment of whether a combination would render the device inoperable must not

“ignore the modifications that one skilled in the art would make to a device

borrowed from the prior art.”

Id.

at 1382, 83 USPQ2d at

1752.

Example 6:

Agrizap, Inc. v. Woodstream Corp.,

520 F.3d 1337, 86 USPQ2d

1110 (Fed. Cir. 2008), involved a stationary pest control device for electrocution

of pests such as rats and gophers, in which the device is set in an area where the

pest is likely to encounter it. The only difference between the claimed device and

the prior art stationary pest control device was that the claimed device employed

a resistive electrical switch, while the prior art device used a mechanical

pressure switch. A resistive electrical switch was taught in two prior art

patents, in the contexts of a hand-held pest control device and a cattle prod

re the

pest is likely to encounter it. The only difference between the claimed device and

the prior art stationary pest control device was that the claimed device employed

a resistive electrical switch, while the prior art device used a mechanical

pressure switch. A resistive electrical switch was taught in two prior art

patents, in the contexts of a hand-held pest control device and a cattle prod.

In determining that the claimed invention was

obvious, the Federal Circuit noted that “[t]he asserted claims simply substitute a

resistive electrical switch for the mechanical pressure switch” employed in the

prior art device.

Id.

at 1344, 86 USPQ2d at 1115. In this case,

the prior art concerning the hand-held devices revealed that the function of the

substituted resistive electrical switch was well known and predictable, and that

it could be used in a pest control device. According to the Federal Circuit, the

references that taught the hand-held devices showed that “the use of an animal

body as a resistive switch to complete a circuit for the generation of an electric

charge was already well known in the prior art.”

Id.

Finally,

the Federal Circuit noted that the problem solved by using the resistive

electrical switch in the prior art hand-held devices – malfunction of mechanical

switches due to dirt and dampness – also pertained to the prior art stationary

pest control device.

The Federal Circuit recognized

Agrizap

as “a textbook case of when the asserted claims involve a

combination of familiar elements according to known methods that does no more than

yield predictable results.”

Id.

Agrizap

exemplifies a strong case of obviousness based on

simple substitution that was not overcome by the objective evidence of

nonobviousness offered. It also demonstrates that analogous art is not limited to

the field of the inventor’s endeavor, in that one of the references that used an

animal body as a resistive switch to complete a circuit for the generation of an

electric charge was not in the field of pest control

ong case of obviousness based on

simple substitution that was not overcome by the objective evidence of

nonobviousness offered. It also demonstrates that analogous art is not limited to

the field of the inventor’s endeavor, in that one of the references that used an

animal body as a resistive switch to complete a circuit for the generation of an

electric charge was not in the field of pest control.

Example 7:

The invention at issue in

Muniauction,

Inc. v. Thomson Corp.,

532 F.3d 1318, 87 USPQ2d1350 (Fed. Cir. 2008),

was a method for auctioning municipal bonds over the Internet. A municipality

could offer a package of bond instruments of varying principal amounts and

maturity dates, and an interested buyer would then submit a bid comprising a price

and interest rate for each maturity date. It was also possible for the interested

buyer to bid on a portion of the offering. The claimed invention considered all of

the noted parameters to determine the best bid. It operated on conventional Web

browsers and allowed participants to monitor the course of the auction.

The only difference between the prior art bidding

system and the claimed invention was the use of a conventional Web browser. At

trial, the district court had determined that Muniauction’s claims were not

obvious. Thomson argued that the claimed invention amounted to incorporating a Web

browser into a prior art auction system, and was therefore obvious in light of

KSR.

Muniauction rebutted the argument by offering evidence

of skepticism by experts, copying, praise, and commercial success. Although the

district court found the evidence to be persuasive of nonobviousness, the Federal

Circuit disagreed. It noted that a nexus between the claimed invention and the

proffered evidence was lacking because the evidence was not coextensive with the

claims at issue. For this reason, the Federal Circuit determined that

Muniauction’s evidence of secondary considerations was not entitled to substantial

weight

istrict court found the evidence to be persuasive of nonobviousness, the Federal

Circuit disagreed. It noted that a nexus between the claimed invention and the

proffered evidence was lacking because the evidence was not coextensive with the

claims at issue. For this reason, the Federal Circuit determined that

Muniauction’s evidence of secondary considerations was not entitled to substantial

weight.

The Federal Circuit analogized this case to

Leapfrog Enters., Inc. v. Fisher-Price, Inc.,

485 F.3d 1157,

82 USPQ2d 1687 (Fed. Cir. 2007). The

Leapfrog

case involved a

determination of obviousness based on application of modern electronics to a prior

art mechanical children’s learning device. In

Leapfrog,

the

court noted that market pressures would have prompted a person of ordinary skill

to use modern electronics in the prior art device. Similarly in

Muniauction,

market pressures would have prompted a person

of ordinary skill to use a conventional Web browser in a method of auctioning

municipal bonds.

Example 8:

In

Aventis Pharma Deutschland v. Lupin

Ltd.,

499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007), the claims were

drawn to the 5(S) stereoisomer of the blood pressure drug ramipril in

stereochemically pure form, and to compositions and methods requiring 5(S)

ramipril. The 5(S) stereoisomer is one in which all five stereocenters in the

ramipril molecule are in the S rather than the R configuration. A mixture of

various stereoisomers including 5(S) ramipril had been taught by the prior art.

The question before the court was whether the purified single stereoisomer would

have been obvious over the known mixture of stereoisomers.

The record showed that the presence of multiple S

stereocenters in drugs similar to ramipril was known to be associated with

enhanced therapeutic efficacy. For example, when all of the stereocenters were in

the S form in the related drug enalapril (SSS enalapril) as compared with only two

stereocenters in the S form (SSR enalapril), the therapeutic potency was 700 times

as great

of stereoisomers.

The record showed that the presence of multiple S

stereocenters in drugs similar to ramipril was known to be associated with

enhanced therapeutic efficacy. For example, when all of the stereocenters were in

the S form in the related drug enalapril (SSS enalapril) as compared with only two

stereocenters in the S form (SSR enalapril), the therapeutic potency was 700 times

as great. There was also evidence to indicate that conventional methods could be

used to separate the various stereoisomers of ramipril.

The district court saw the issue as a close case,

because, in its view, there was no clear motivation in the prior art to isolate

5(S) ramipril. However, the Federal Circuit disagreed, and found that the claims

would have been obvious. The Federal Circuit cautioned that requiring such a

clearly stated motivation in the prior art to isolate 5(S) ramipril ran counter to

the Supreme Court’s decision in KSR, and the court stated:

Requiring an explicit teaching to purify the

5(S) stereoisomer from a mixture in which it is the active ingredient is

precisely the sort of rigid application of the TSM test that was criticized in

KSR.

Id.

at 1301, 84 USPQ2d at 1204. The

Aventis

court also relied on the settled principle that in chemical cases, structural

similarity can provide the necessary reason to modify prior art teachings. The

Federal Circuit also addressed the kind of teaching that would be sufficient in

the absence of an explicitly stated prior art-based motivation, explaining that an

expectation of similar properties in light of the prior art can be sufficient,

even without an explicit teaching that the compound will have a particular

utility.

In the chemical arts, the cases involving so-called

“lead compounds” form an important subgroup of the obviousness cases that are

based on substitution. The Federal Circuit has had a number of opportunities since

the

KSR

decision to discuss the circumstances under which it

would have been obvious to modify a known compound to arrive at a claimed

compound

he compound will have a particular

utility.

In the chemical arts, the cases involving so-called

“lead compounds” form an important subgroup of the obviousness cases that are

based on substitution. The Federal Circuit has had a number of opportunities since

the

KSR

decision to discuss the circumstances under which it

would have been obvious to modify a known compound to arrive at a claimed

compound. The following cases explore the selection of a lead compound, the need

to provide a reason for any proposed modification, and the predictability of the

result.

Example 9:

Eisai Co. Ltd. v. Dr. Reddy’s Labs., Ltd.,

533 F.3d 1353, 87

USPQ2d 1452 (Fed. Cir. 2008), concerns the pharmaceutical compound rabeprazole.

Rabeprazole is a proton pump inhibitor for treating stomach ulcers and related

disorders. The Federal Circuit affirmed the district court’s summary judgment of

nonobviousness, stating that no reason had been advanced to modify the prior art

compound in a way that would destroy an advantageous property.

Co-defendant Teva based its obviousness argument on

the structural similarity between rabeprazole and lansoprazole. The compounds were

recognized as sharing a common core, and the Federal Circuit characterized

lansoprazole as a “lead compound.” The prior art compound lansoprazole was useful

for the same indications as rabeprazole, and differed from rabeprazole only in

that lansoprazole has a trifluoroethoxy substituent at the 4-position of the

pyridine ring, while rabeprazole has a methoxypropoxy substituent. The trifluoro

substituent of lansoprazole was known to be a beneficial feature because it

conferred lipophilicity to the compound. The ability of a person of ordinary skill

to carry out the modification to introduce the methoxypropoxy substituent, and the

predictability of the result were not addressed.

Despite the significant similarity between the

structures, the Federal Circuit did not find any reason to modify the lead

compound

razole was known to be a beneficial feature because it

conferred lipophilicity to the compound. The ability of a person of ordinary skill

to carry out the modification to introduce the methoxypropoxy substituent, and the

predictability of the result were not addressed.

Despite the significant similarity between the

structures, the Federal Circuit did not find any reason to modify the lead

compound. According to the Federal Circuit:

Obviousness based on structural similarity thus

can be proved by identification of some motivation that would have led one of

ordinary skill in the art to select and then modify a known compound (i.e. a

lead compound) in a particular way to achieve the claimed compound. . . . In

keeping with the flexible nature of the obviousness inquiry, the requisite

motivation can come from any number of sources and need not necessarily be

explicit in the art. Rather “it is sufficient to show that the claimed and

prior art compounds possess a ‘sufficiently close relationship . . . to create

an expectation,’ in light of the totality of the prior art, that the new

compound will have ‘similar properties’ to the old.”

Id.

at

1357, 87 USPQ2d at 1455. (citations omitted)

The prior art taught that introducing a fluorinated

substituent was known to increase lipophilicity, so a skilled artisan would have

expected that replacing the trifluoroethoxy substituent with a methoxypropoxy

substituent would have reduced the lipophilicity of the compound. Thus, the prior

art created the expectation that rabeprazole would be less useful than

lansoprazole as a drug for treating stomach ulcers and related disorders because

the proposed modification would have destroyed an advantageous property of the

prior art compound. The compound was not obvious as argued by Teva because, upon

consideration of all of the facts of the case, a person of ordinary skill in the

art at the time of the invention would not have had a reason to modify

lansoprazole so as to form rabeprazole

ting stomach ulcers and related disorders because

the proposed modification would have destroyed an advantageous property of the

prior art compound. The compound was not obvious as argued by Teva because, upon

consideration of all of the facts of the case, a person of ordinary skill in the

art at the time of the invention would not have had a reason to modify

lansoprazole so as to form rabeprazole.

Office personnel are cautioned that the term “lead

compound” in a particular opinion can have a contextual meaning that may vary from

the way a pharmaceutical chemist might use the term. In the field of

pharmaceutical chemistry, the term “lead compound” has been defined variously as

“a chemical compound that has pharmacological or biological activity and whose

chemical structure is used as a starting point for chemical modifications in order

to improve potency, selectivity, or pharmacokinetic parameters;” “[a] compound

that exhibits pharmacological properties which suggest its development;” and “a

potential drug being tested for safety and efficacy.” See, e.g.,

http://en.wikipedia.org/wiki/Lead_compound, accessed January 13, 2010;

www.combichemistry.com/glossary_k.html, accessed January 13, 2010; and

www.buildingbiotechnology.com/glossary4.php, accessed January 13, 2010.

The Federal Circuit in

Eisai

makes it clear that from the perspective of the law of obviousness, any known

compound might possibly serve as a lead compound: “Obviousness based on structural

similarity thus can be proved by identification of some motivation that would have

led one of ordinary skill in the art to select and then modify a known compound

(i.e. a lead compound) in a particular way to achieve the claimed compound.”

Eisai,

533 F.3d at 1357, 87 USPQ2d at 1455

the law of obviousness, any known

compound might possibly serve as a lead compound: “Obviousness based on structural

similarity thus can be proved by identification of some motivation that would have

led one of ordinary skill in the art to select and then modify a known compound

(i.e. a lead compound) in a particular way to achieve the claimed compound.”

Eisai,

533 F.3d at 1357, 87 USPQ2d at 1455. Thus, Office

personnel should recognize that a proper obviousness rejection of a claimed

compound that is useful as a drug might be made beginning with an inactive

compound, if, for example, the reasons for modifying a prior art compound to

arrive at the claimed compound have nothing to do with pharmaceutical activity.

The inactive compound would not be considered to be a lead compound by

pharmaceutical chemists, but could potentially be used as such when considering

obviousness. Office personnel might also base an obviousness rejection on a known

compound that pharmaceutical chemists would not select as a lead compound due to

expense, handling issues, or other business considerations. However, there must be

some reason for starting with that particular lead compound other than the mere

fact that the “lead compound” exists. See

Altana Pharma AG v. Teva Pharm.

USA, Inc.,

566 F.3d 999, 1007, 91 USPQ2d 1018, 1024 (Fed. Cir. 2009)

(holding that there must be some reason “to select and modify a known compound”);

Ortho-McNeil Pharm., Inc. v. Mylan Labs, Inc.,

520 F.3d

1358, 1364, 86 USPQ2d 1196, 1201 (Fed. Cir. 2008).

Example 10:

The claimed chemical compound was also found to be

nonobvious in

Procter & Gamble Co. v. Teva Pharm. USA,

Inc.,

566 F.3d 989, 90 USPQ2d 1947 (Fed. Cir. 2009). The compound at

issue was risedronate – the active ingredient of Procter & Gamble’s

osteoporosis drug Actonel

®

. Risedronate is an example

of a bisphosphonate, which is a class of compounds known to inhibit bone

resorption

008).

Example 10:

The claimed chemical compound was also found to be

nonobvious in

Procter & Gamble Co. v. Teva Pharm. USA,

Inc.,

566 F.3d 989, 90 USPQ2d 1947 (Fed. Cir. 2009). The compound at

issue was risedronate – the active ingredient of Procter & Gamble’s

osteoporosis drug Actonel

®

. Risedronate is an example

of a bisphosphonate, which is a class of compounds known to inhibit bone

resorption.

When Procter & Gamble sued Teva for

infringement, Teva defended by arguing invalidity for obviousness over one of

Procter & Gamble’s earlier patents. The prior art patent did not teach

risedronate, but instead taught thirty-six other similar compounds including 2-pyr

EHDP that were potentially useful with regard to osteoporosis. Teva argued

obviousness on the basis of structural similarity to 2-pyr EHDP, which is a

positional isomer of risedronate.

The district court found no reason to select 2-pyr

EHDP as a lead compound in light of the unpredictable nature of the art, and no

reason to modify it so as to obtain risedronate. In addition, there were

unexpected results as to potency and toxicity. Therefore the district court found

that Teva had not made a

prima facie

case, and even if it had,

it was rebutted by evidence of unexpected results.

The Federal Circuit affirmed the district court’s

decision. The Federal Circuit did not deem it necessary in this case to consider

the question of whether 2-pyr EHDP had been appropriately selected as a lead

compound. Rather, the Federal Circuit reasoned that, if 2-pyr EHDP is presumed to

be an appropriate lead compound, there must be both a reason to modify it so as to

make risedronate and a reasonable expectation of success. Here, there was no

evidence that the necessary modifications would have been routine, so there would

have been no reasonable expectation of success.

Procter & Gamble

is also informative in its discussion of

the treatment of secondary considerations of non-obviousness

propriate lead compound, there must be both a reason to modify it so as to

make risedronate and a reasonable expectation of success. Here, there was no

evidence that the necessary modifications would have been routine, so there would

have been no reasonable expectation of success.

Procter & Gamble

is also informative in its discussion of

the treatment of secondary considerations of non-obviousness. Although the court

found that no

prima facie

case of obviousness had been

presented, it proceeded to analyze Procter & Gamble’s proffered evidence

countering the alleged

prima facie

case in some detail, thus

shedding light on the proper treatment of such evidence.

The Federal Circuit noted in dicta that even if a

prima facie

case of obviousness had been established,

sufficient evidence of unexpected results was introduced to rebut such a showing.

At trial, the witnesses consistently testified that the properties of risedronate

were not expected, offering evidence that researchers did not predict either the

potency or the low dose at which the compound was effective. Tests comparing

risedronate to a compound in the prior art reference showed that risedronate

outperformed the other compound by a substantial margin, could be administered in

a greater amount without an observable toxic effect, and was not lethal at the

same levels as the other compound. The weight of the evidence and the credibility

of the witnesses were sufficient to show unexpected results that would have

rebutted an obviousness determination. Thus, nonobviousness can be shown when a

claimed invention is shown to have unexpectedly superior properties when compared

to the prior art.

The court then addressed the evidence of commercial

success of risedronate and the evidence that risedronate met a long felt need. The

court pointed out that little weight was to be afforded to the commercial success

because the competing product was also assigned to Procter & Gamble

be shown when a

claimed invention is shown to have unexpectedly superior properties when compared

to the prior art.

The court then addressed the evidence of commercial

success of risedronate and the evidence that risedronate met a long felt need. The

court pointed out that little weight was to be afforded to the commercial success

because the competing product was also assigned to Procter & Gamble. However,

the Federal Circuit affirmed the district court’s conclusion that risedronate met

a long-felt, but unsatisfied need. The court rejected Teva’s contention that

because the competing drug was available before

Actonel

®

, there was no unmet need that the invention

satisfied. The court emphasized that whether there was a long-felt but unsatisfied

need is to be evaluated based on the circumstances as of the filing date of the

challenged invention – not as of the date that the invention is brought to market.

It should be noted that the lead compound cases do

not stand for the proposition that identification of a single lead compound is

necessary in every obviousness rejection of a chemical compound. For example, one

might envision a suggestion in the prior art to formulate a compound having

certain structurally defined moieties, or moieties with certain properties. If a

person of ordinary skill would have known how to synthesize such a compound, and

the structural and/or functional result could reasonably have been predicted, then

a

prima facie

case of obviousness of the claimed chemical

compound might exist even without identification of a particular lead compound. As

a second example, it could be possible to view a claimed compound as consisting of

two known compounds attached via a chemical linker. The claimed compound might

properly be found to have been obvious if there would have been a reason to link

the two, if one of ordinary skill would have known how to do so, and if the

resulting compound would have been the predictable result of the linkage

procedure

second example, it could be possible to view a claimed compound as consisting of

two known compounds attached via a chemical linker. The claimed compound might

properly be found to have been obvious if there would have been a reason to link

the two, if one of ordinary skill would have known how to do so, and if the

resulting compound would have been the predictable result of the linkage

procedure. Thus, Office personnel should recognize that in certain situations, it

may be proper to reject a claimed chemical compound as obvious even without

identifying a single lead compound.

Example 11:

The decision reached by the Federal Circuit

in

Altana Pharma AG v. Teva Pharm. USA, Inc.,

566 F.3d 999,

91 USPQ2d 1018 (Fed. Cir. 2009), as discussed below, involved a motion for

preliminary injunction and did not include a final determination of obviousness.

However, the case is instructive as to the issue of selecting a lead compound.

The technology involved in

Altana

was the compound pantoprazole, which is the active

ingredient in Altana’s antiulcer drug Protonix

®

.

Pantoprazole belongs to a class of compounds known as proton pump inhibitors that

are used to treat gastric acid disorders in the stomach.

Altana accused Teva of infringement. The district

court denied Altana’s motion for preliminary injunction for failure to establish a

likelihood of success on the merits, determining that Teva had demonstrated a

substantial question of invalidity for obviousness in light of one of Altana’s

prior patents. Altana’s patent discussed a compound referred to as compound 12,

which was one of eighteen compounds disclosed. The claimed compound pantoprazole

was structurally similar to compound 12. The district court found that one of

ordinary skill in the art would have selected compound 12 as a lead compound for

modification, and the Federal Circuit affirmed

sness in light of one of Altana’s

prior patents. Altana’s patent discussed a compound referred to as compound 12,

which was one of eighteen compounds disclosed. The claimed compound pantoprazole

was structurally similar to compound 12. The district court found that one of

ordinary skill in the art would have selected compound 12 as a lead compound for

modification, and the Federal Circuit affirmed.

Obviousness of a chemical compound in view of its

structural similarity to a prior art compound may be shown by identifying some

line of reasoning that would have led one of ordinary skill in the art to select

and modify the prior art compound in a particular way to produce the claimed

compound. The necessary line of reasoning can be drawn from any number of sources

and need not necessarily be explicitly found in the prior art of record. The

Federal Circuit determined that ample evidence supported the district court’s

finding that compound 12 was a natural choice for further development. For

example, Altana’s prior art patent claimed that its compounds, including compound

12, were improvements over the prior art; compound 12 was disclosed as one of the

more potent of the eighteen compounds disclosed; the patent examiner had

considered the compounds of Altana’s prior art patent to be relevant during the

prosecution of the patent in suit; and experts had opined that one of ordinary

skill in the art would have selected the eighteen compounds to pursue further

investigation into their potential as proton pump inhibitors.

In response to Altana’s argument that the prior art

must point to only a single lead compound for further development, the Federal

Circuit stated that a “restrictive view of the lead compound test would present a

rigid test similar to the teaching-suggestion-motivation test that the Supreme

Court explicitly rejected in

KSR

. . .

urther

investigation into their potential as proton pump inhibitors.

In response to Altana’s argument that the prior art

must point to only a single lead compound for further development, the Federal

Circuit stated that a “restrictive view of the lead compound test would present a

rigid test similar to the teaching-suggestion-motivation test that the Supreme

Court explicitly rejected in

KSR

. . . . The district court in

this case employed a flexible approach – one that was admittedly preliminary – and

found that the defendants had raised a substantial question that one of skill in

the art would have used the more potent compounds of [Altana’s prior art] patent,

including compound 12, as a starting point from which to pursue further

development efforts. That finding was not clearly erroneous.”

Id.

at 1008, 91 USPQ2d at 1025.

C.

Use of Known Technique To Improve Similar Devices (Methods, or Products)

in the Same Way

To reject a claim based on this rationale, Office personnel must

resolve the

Graham

factual inquiries. Then, Office personnel must

articulate the following:

(1) a finding that the prior art contained a “base” device

(method, or product) upon which the claimed invention can be seen as an

“improvement;”

(2) a finding that the prior art contained a “comparable” device

(method, or product that is not the same as the base device) that has been

improved in the same way as the claimed invention;

(3) a finding that one of ordinary skill in the art could have

applied the known “improvement” technique in the same way to the “base” device

(method, or product) and the results would have been predictable to one of

ordinary skill in the art; and

ined a “comparable” device

(method, or product that is not the same as the base device) that has been

improved in the same way as the claimed invention;

(3) a finding that one of ordinary skill in the art could have

applied the known “improvement” technique in the same way to the “base” device

(method, or product) and the results would have been predictable to one of

ordinary skill in the art; and

(4) whatever additional findings based on the

Graham

factual inquiries may be necessary, in view of the

facts of the case under consideration, to explain a conclusion of obviousness.

The rationale to support a conclusion that the claim would have

been obvious is that a method of enhancing a particular class of devices (methods, or

products) has been made part of the ordinary capabilities of one skilled in the art

based upon the teaching of such improvement in other situations. One of ordinary

skill in the art would have been capable of applying this known method of enhancement

to a “base” device (method, or product) in the prior art and the results would have

been predictable to one of ordinary skill in the art. “It's enough … to show that

there was a known problem … in the art, that [another reference] … helped address

that issue, and that combining the teachings of [the two references] wasn't beyond

the skill of an ordinary artisan. Nothing more is required to show a motivation to

combine under

KSR.

” See

Intel Corp. v. PACT XPP Schweiz

AG,

61 F.4th 1373, 1380-81, 2023 USPQ2d 297 (Fed. Cir. 2023) (finding

that both prior art references “address the same problem and that [the secondary

reference’s] cache was a known way to address that problem is precisely the reason

that there's a motivation to combine under

KSR

and our

precedent.”).

The Supreme Court in

KSR

noted

that if the actual application of the technique would have been beyond the skill of

one of ordinary skill in the art, then using the technique would not have been

obvious.

KSR,

550 U.S. at 417, 82 USPQ2d at 1396

ndary

reference’s] cache was a known way to address that problem is precisely the reason

that there's a motivation to combine under

KSR

and our

precedent.”).

The Supreme Court in

KSR

noted

that if the actual application of the technique would have been beyond the skill of

one of ordinary skill in the art, then using the technique would not have been

obvious.

KSR,

550 U.S. at 417, 82 USPQ2d at 1396. If any of these

findings cannot be made, then this rationale cannot be used to support a conclusion

that the claim would have been obvious to one of ordinary skill in the art.

Example 1:

The claimed invention in

In re Nilssen,

851

F.2d 1401, 7 USPQ2d 1500 (Fed. Cir. 1988) was directed to a “means by which the

self-oscillating inverter in a power-line-operated inverter-type fluorescent lamp

ballast is disabled in case the output current from the inverter exceeds some

pre-established threshold level for more than a very brief period.”

Id.

at 1402, 7 USPQ2d at 1501 That is, the current output

was monitored, and if the current output exceeded some threshold for a specified

short time, an actuation signal was sent and the inverter was disabled to protect

it from damage.

The prior art (a USSR certificate) described a device for

protecting an inverter circuit in an undisclosed manner via a control means. The

device indicated the high-load condition by way of the control means, but did not

indicate the specific manner of overload protection. The prior art (Kammiller)

disclosed disabling the inverter in the event of a high-load current condition in

order to protect the inverter circuit. That is, the overload protection was

achieved by disabling the inverter by means of a cutoff switch.

The court found “it would have been obvious to one of ordinary

skill in the art to use the threshold signal produced in the USSR device to

actuate a cutoff switch to render the inverter inoperative as taught by

Kammiller.”

Id.

at 1403, 7 USPQ2d at 1502

tion in

order to protect the inverter circuit. That is, the overload protection was

achieved by disabling the inverter by means of a cutoff switch.

The court found “it would have been obvious to one of ordinary

skill in the art to use the threshold signal produced in the USSR device to

actuate a cutoff switch to render the inverter inoperative as taught by

Kammiller.”

Id.

at 1403, 7 USPQ2d at 1502. That is, using the

known technique of a cutoff switch for protecting a circuit to provide the

protection desired in the inverter circuit of the USSR document would have been

obvious to one of ordinary skill.

Example 2:

The fact pattern in

Ruiz v. AB Chance Co.,

357

F.3d 1270, 69 USPQ2d 1686 (Fed. Cir. 2004) is set forth above in Example 2 in

subsection I.A.

The nature of the problem to be solved may lead inventors to look

at references relating to possible solutions to that problem.

Id.

at 1277, 69 USPQ2d at 1691. Therefore, it would have

been obvious to use a metal bracket (as shown in Gregory) with the screw anchor

(as shown in Fuller) to underpin unstable foundations.

D.

Applying a Known Technique to a Known Device (Method, or Product) Ready

for Improvement To Yield Predictable Results

To reject a claim based on this rationale, Office personnel must

resolve the

Graham

factual inquiries. Then, Office personnel must

articulate the following:

(1) a finding that the prior art contained a “base” device

(method, or product) upon which the claimed invention can be seen as an

“improvement;”

(2) a finding that the prior art contained a known technique that

is applicable to the base device (method, or product);

(3) a finding that one of ordinary skill in the art would have

recognized that applying the known technique would have yielded predictable

results and resulted in an improved system; and

evice

(method, or product) upon which the claimed invention can be seen as an

“improvement;”

(2) a finding that the prior art contained a known technique that

is applicable to the base device (method, or product);

(3) a finding that one of ordinary skill in the art would have

recognized that applying the known technique would have yielded predictable

results and resulted in an improved system; and

(4) whatever additional findings based on the

Graham

factual inquiries may be necessary, in view of the

facts of the case under consideration, to explain a conclusion of obviousness.

The rationale to support a conclusion that the claim would have

been obvious is that a particular known technique was recognized as part of the

ordinary capabilities of one skilled in the art. One of ordinary skill in the art

would have been capable of applying this known technique to a known device (method,

or product) that was ready for improvement and the results would have been

predictable to one of ordinary skill in the art. If any of these findings cannot be

made, then this rationale cannot be used to support a conclusion that the claim would

have been obvious to one of ordinary skill in the art.

Example 1:

The claimed invention in

Dann v. Johnston,

425

U.S. 219, 189 USPQ 257 (1976) was directed towards a system (i.e., computer) for

automatic record keeping of bank checks and deposits. In this system, a customer

would put a numerical category code on each check or deposit slip. The check

processing system would record these on the check in magnetic ink, just as it does

for amount and account information. With this system in place, the bank can

provide statements to customers that are broken down to give subtotals for each

category. The claimed system also allowed the bank to print reports according to a

style requested by the customer

code on each check or deposit slip. The check

processing system would record these on the check in magnetic ink, just as it does

for amount and account information. With this system in place, the bank can

provide statements to customers that are broken down to give subtotals for each

category. The claimed system also allowed the bank to print reports according to a

style requested by the customer. As characterized by the Court, “[u]nder

respondent’s invention, then, a general purpose computer is programmed to provide

bank customers with an individualized and categorized breakdown of their

transactions during the period in question.”

Id.

at 222, 189

USPQ at 259.

BASE SYSTEM - The nature of the use of data processing equipment

and computer software in the banking industry was that banks routinely did much of

the record-keeping automatically. In routine check processing, the system read any

magnetic ink characters identifying the account and routing. The system also read

the amount of the check and then printed that value in a designated area of the

check. The check was then sent through a further data processing step which used

the magnetic ink information to generate the appropriate records for transactions

and for posting to the appropriate accounts. These systems included generating

periodic statements for each account, such as the monthly statement sent to

checking account customers.

IMPROVED SYSTEM - The claimed invention supplemented this system

by recording a category code which could be used to track expenditures by

category. Again, the category code will be a number recorded on the check (or

deposit slip) which will be read, converted into a magnetic ink imprint, and then

processed in the data system to include the category code. This enabled reporting

of data by category as opposed to only allowing reporting by account number

s system

by recording a category code which could be used to track expenditures by

category. Again, the category code will be a number recorded on the check (or

deposit slip) which will be read, converted into a magnetic ink imprint, and then

processed in the data system to include the category code. This enabled reporting

of data by category as opposed to only allowing reporting by account number.

KNOWN TECHNIQUE - This is an application of a technique from the

prior art – the use of account numbers (generally used to track an individual's

total transactions) to solve the problem of how to track categories of

expenditures to more finely account for a budget. That is, account numbers

(identifying data capable of processing in the automatic data processing system)

were used to distinguish between different customers. Furthermore, banks have long

segregated debits attributable to service charges within any given separate

account and have rendered their customers subtotals for those charges. Previously,

one would have needed to set up separate accounts for each category and thus

receive separate reports. Supplementing the account information with additional

digits (the category codes) solved the problem by effectively creating a single

account that can be treated as distinct accounts for tracking and reporting

services. That is, the category code merely allowed what might previously have

been separate accounts to be handled as a single account, but with a number of

sub-accounts indicated in the report.

The basic technique of putting indicia on data to enable standard

sorting, searching, and reporting yielded no more than the predictable outcome

which one of ordinary skill would have expected to achieve with this common tool

of the trade and was therefore an obvious expedient. The Court held that “[t]he

gap between the prior art and respondent’s system is simply not so great as to

render the system nonobvious to one reasonably skilled in the art.”

Id.

at 230, 189 USPQ at 261

hing, and reporting yielded no more than the predictable outcome

which one of ordinary skill would have expected to achieve with this common tool

of the trade and was therefore an obvious expedient. The Court held that “[t]he

gap between the prior art and respondent’s system is simply not so great as to

render the system nonobvious to one reasonably skilled in the art.”

Id.

at 230, 189 USPQ at 261.

Example 2:

The fact pattern in

In re Nilssen,

851 F.2d

1401, 7 USPQ2d 1500 (Fed. Cir. 1988) is set forth above in Example 1 in subsection

C.

The court found “it would have been obvious to one of ordinary

skill in the art to use the threshold signal produced in the USSR device to

actuate a cutoff switch to render the inverter inoperative as taught by

Kammiller.”

Id.

at 1403, 7 USPQ2d at 1502. The known

technique of using a cutoff switch would have predictably resulted in protecting

the inverter circuit. Therefore, it would have been within the skill of the

ordinary artisan to use a cutoff switch in response to the actuation signal to

protect the inverter.

Example 3:

The claimed invention in

In re

Urbanski,

809 F.3d 1237, 1244, 117 USPQ2d 1499, 1504 (Fed. Cir. 2016)

was directed to a method of enzymatic hydrolysis of soy fiber to reduce water

holding capacity, requiring reacting the soy fiber and enzyme in water for about

60-120 minutes. The claims were rejected over two references, wherein the primary

reference, Gross, taught using a reaction time of 5 to 72 hours and the secondary

reference, Wong, taught using a reaction time of 100 to 240 minutes, preferably

120 minutes. The applicant argued that modifying the primary reference in the

manner suggested by the secondary reference would forego the benefits taught by

the primary reference, thereby teaching away from the combination

in the primary

reference, Gross, taught using a reaction time of 5 to 72 hours and the secondary

reference, Wong, taught using a reaction time of 100 to 240 minutes, preferably

120 minutes. The applicant argued that modifying the primary reference in the

manner suggested by the secondary reference would forego the benefits taught by

the primary reference, thereby teaching away from the combination. The court found

there was sufficient motivation to combine because both references recognized

reaction time and degree of hydrolysis as result-effective variables, which can be

varied to have a predictable effect on the final product; and the primary

reference does not contain an express teaching away from the proposed

modification. “Substantial evidence thus supports the Board’s finding that a

person of ordinary skill would have been motivated to modify the Gross process by

using a shorter reaction time, in order to obtain the favorable properties

disclosed in Wong.”

E.

“Obvious To Try” – Choosing From a Finite Number of Identified,

Predictable Solutions, With a Reasonable Expectation of Success

To reject a claim based on this rationale, Office personnel must

resolve the

Graham

factual inquiries. Then, Office personnel must

articulate the following:

(1) a finding that at the relevant time, there had been a

recognized problem or need in the art, which may include a design need or

market pressure to solve a problem;

(2) a finding that there had been a finite number of identified,

predictable potential solutions to the recognized need or problem;

(3) a finding that one of ordinary skill in the art could have

pursued the known potential solutions with a reasonable expectation of success;

and

had been a

recognized problem or need in the art, which may include a design need or

market pressure to solve a problem;

(2) a finding that there had been a finite number of identified,

predictable potential solutions to the recognized need or problem;

(3) a finding that one of ordinary skill in the art could have

pursued the known potential solutions with a reasonable expectation of success;

and

(4) whatever additional findings based on the

Graham

factual inquiries may be necessary, in view of the

facts of the case under consideration, to explain a conclusion of obviousness.

The rationale to support a conclusion that the claim would have

been obvious is that “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 that product [was] 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 obvious under

§ 103

.”

KSR,

550 U.S. at 421, 82 USPQ2d at 1397. If any of these findings cannot be made, then

this rationale cannot be used to support a conclusion that the claim would have been

obvious to one of ordinary skill in the art.

The question of whether a claimed invention can be

shown to be obvious based on an “obvious to try” line of reasoning has been explored

extensively by the Federal Circuit in several cases since the

KSR

decision. The case law in this area is developing quickly in the chemical arts,

although the rationale has been applied in other art areas as well.

Some commentators on the

KSR

decision have expressed a concern that because inventive activities are always

carried out in the context of what has come before and not in a vacuum, few

inventions will survive scrutiny under an obvious to try standard. The cases decided

since KSR have proved this fear to have been unfounded

al arts,

although the rationale has been applied in other art areas as well.

Some commentators on the

KSR

decision have expressed a concern that because inventive activities are always

carried out in the context of what has come before and not in a vacuum, few

inventions will survive scrutiny under an obvious to try standard. The cases decided

since KSR have proved this fear to have been unfounded. Courts appear to be applying

the KSR requirement for “a finite number of identified predictable solutions” in a

manner that places particular emphasis on predictability and the reasonable

expectations of those of ordinary skill in the art.

The Federal Circuit pointed out the challenging nature

of the task faced by the courts – and likewise by Office personnel – when considering

the viability of an obvious to try argument: “The evaluation of the choices made by a

skilled scientist, when such choices lead to the desired result, is a challenge to

judicial understanding of how technical advance is achieved in the particular field

of science or technology.”

Abbott Labs. v. Sandoz, Inc.,

544 F.3d

1341, 1352, 89 USPQ2d 1161, 1171 (Fed. Cir. 2008). The Federal Circuit cautioned that

an obviousness inquiry based on an obvious to try rationale must always be undertaken

in the context of the subject matter in question, “including the characteristics of

the science or technology, its state of advance, the nature of the known choices, the

specificity or generality of the prior art, and the predictability of results in the

area of interest.”

Id.

Example 1:

The claimed invention in

Pfizer, Inc. v. Apotex,

Inc.,

480 F.3d 1348, 82 USPQ2d 1321 (Fed. Cir. 2007), was directed to

the amlodipine besylate drug product, which was sold in tablet form in the United

States under the trademark Norvasc

®

. Amlodipine and the

use of besylate anions were both known at the time of the invention

nd the predictability of results in the

area of interest.”

Id.

Example 1:

The claimed invention in

Pfizer, Inc. v. Apotex,

Inc.,

480 F.3d 1348, 82 USPQ2d 1321 (Fed. Cir. 2007), was directed to

the amlodipine besylate drug product, which was sold in tablet form in the United

States under the trademark Norvasc

®

. Amlodipine and the

use of besylate anions were both known at the time of the invention. Amlodipine

was known to have the same therapeutic properties as were being claimed for the

amlodipine besylate, but Pfizer discovered that the besylate form had better

manufacturing properties (e.g., reduced “stickiness”).

Pfizer argued that the results of forming amlodipine besylate

would have been unpredictable and therefore nonobvious. The court rejected the

notion that unpredictability could be equated with nonobviousness here, because

there were only a finite number (53) of

pharmaceutically acceptable

salts to be tested for improved properties.

The court found that one of ordinary skill in the art having

problems with the machinability of amlodipine would have looked to forming a salt

of the compound and would have been able to narrow the group of potential

salt-formers to a group of 53 anions known to form pharmaceutically acceptable

salts, which would be an acceptable number to form “a reasonable expectation of

success.”

Example 2:

The claimed invention in

Alza Corp. v. Mylan Labs.,

Inc.,

464 F.3d 1286, 80 USPQ2d 1001 (Fed. Cir. 2006) was drawn to

sustained-release formulations of the drug oxybutynin in which the drug is

released at a specified rate over a 24-hour period. Oxybutynin was known to be

highly water-soluble, and the specification had pointed out that development of

sustained-release formulations of such drugs presented particular problems.

A prior art patent to Morella had taught sustained-release

compositions of highly water-soluble drugs, as exemplified by a sustained-release

formulation of morphine. Morella had also identified oxybutynin as belonging to

the class of highly water-soluble drugs

uble, and the specification had pointed out that development of

sustained-release formulations of such drugs presented particular problems.

A prior art patent to Morella had taught sustained-release

compositions of highly water-soluble drugs, as exemplified by a sustained-release

formulation of morphine. Morella had also identified oxybutynin as belonging to

the class of highly water-soluble drugs. The Baichwal prior art patent had taught

a sustained-release formulation of oxybutynin that had a different release rate

than the claimed invention. Finally, the Wong prior art patent had taught a

generally applicable method for delivery of drugs over a 24-hour period. Although

Wong mentioned applicability of the disclosed method to several categories of

drugs to which oxybutynin belonged, Wong did not specifically mention its

applicability to oxybutynin.

The court found that because the absorption properties of

oxybutynin would have been reasonably predictable at the time of the invention,

there would have been a reasonable expectation of successful development of a

sustained-release formulation of oxybutynin as claimed. The prior art, as

evidenced by the specification, had recognized the obstacles to be overcome in

development of sustained-release formulations of highly water-soluble drugs, and

had suggested a finite number of ways to overcome these obstacles. The claims were

obvious because it would have been obvious to try the known methods for

formulating sustained-release compositions, with a reasonable expectation of

success. The court was not swayed by arguments of a lack of absolute

predictability.

Example 3:

The Federal Circuit’s decision in

In re

Kubin,

561 F.3d 1351, 90 USPQ2d 1417 (Fed. Cir. 2009), affirmed the

Office’s determination in

Ex parte Kubin,

83 USPQ2d 1410 (Bd.

Pat. App. & Int. 2007) that the claims in question, directed to an isolated

nucleic acid molecule, would have been obvious over the prior art applied. The

claim stated that the nucleic acid encoded a particular polypeptide

mple 3:

The Federal Circuit’s decision in

In re

Kubin,

561 F.3d 1351, 90 USPQ2d 1417 (Fed. Cir. 2009), affirmed the

Office’s determination in

Ex parte Kubin,

83 USPQ2d 1410 (Bd.

Pat. App. & Int. 2007) that the claims in question, directed to an isolated

nucleic acid molecule, would have been obvious over the prior art applied. The

claim stated that the nucleic acid encoded a particular polypeptide. The encoded

polypeptide was identified in the claim by its partially specified sequence, and

by its ability to bind to a specified protein.

A prior art patent to Valiante taught the polypeptide encoded by

the claimed nucleic acid, but did not disclose either the sequence of the

polypeptide, or the claimed isolated nucleic acid molecule. However, Valiante did

disclose that by employing conventional methods such as those disclosed by a prior

art laboratory manual by Sambrook, the sequence of the polypeptide could be

determined, and the nucleic acid molecule could be isolated. In view of Valiante’s

disclosure of the polypeptide, and of routine prior art methods for sequencing the

polypeptide and isolating the nucleic acid molecule, the Board found that a person

of ordinary skill in the art would have had a reasonable expectation that a

nucleic acid molecule within the claimed scope could have been successfully

obtained.

Relying on

In re Deuel,

51 F.3d 1552, 34

USPQ2d 1210 (Fed. Cir. 1995), appellant argued that it was improper for the Office

to use the polypeptide of the Valiante patent together with the methods described

in Sambrook to reject a claim drawn to a specific nucleic acid molecule without

providing a reference showing or suggesting a structurally similar nucleic acid

molecule. Citing

KSR,

the Board stated that “when there is

motivation 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

a claim drawn to a specific nucleic acid molecule without

providing a reference showing or suggesting a structurally similar nucleic acid

molecule. Citing

KSR,

the Board stated that “when there is

motivation 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 anticipated

success, it is likely the product not of innovation but of ordinary skill and

common sense.”

KSR,

550 U.S. at 402-03, 82 USPQ2d at 1390. The

Board noted that the problem facing those in the art was to isolate a specific

nucleic acid, and there were a limited number of methods available to do so. The

Board concluded that the skilled artisan would have had reason to try these

methods with the reasonable expectation that at least one would be successful.

Thus, isolating the specific nucleic acid molecule claimed was “the product not of

innovation but of ordinary skill and common sense.”

Id.

The Board’s reasoning was substantially adopted by

the Federal Circuit. However, it is important to note that in the

Kubin

decision, the Federal Circuit held that “the Supreme

Court in

KSR

unambiguously discredited” the Federal Circuit’s

decision in

Deuel,

insofar as it “implies the obviousness

inquiry cannot consider that the combination of the claim’s constituent elements

was ‘obvious to try.’”

Kubin,

561 F.3d at 1358, 90 USPQ2d at

1422. Instead,

Kubin

stated that

KSR

“resurrects” the Federal Circuit’s own wisdom in

O’Farrell,

in

which “to differentiate between proper and improper applications of ‘obvious to

try,’” the Federal Circuit “outlined two classes of situations where ‘obvious to

try’ is erroneously equated with obviousness under

§ 103

.”

Kubin,

561 F.3d at 1359, 90 USPQ2d at 1423

ubin,

561 F.3d at 1358, 90 USPQ2d at

1422. Instead,

Kubin

stated that

KSR

“resurrects” the Federal Circuit’s own wisdom in

O’Farrell,

in

which “to differentiate between proper and improper applications of ‘obvious to

try,’” the Federal Circuit “outlined two classes of situations where ‘obvious to

try’ is erroneously equated with obviousness under

§ 103

.”

Kubin,

561 F.3d at 1359, 90 USPQ2d at 1423. These two

classes of situations are: (1) when what would have been “obvious to try” would

have been 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; and (2) when what was “obvious to

try” was to explore a new technology or general approach that seemed to be a

promising field of experimentation, where the prior art gave only general guidance

as to the particular form of the claimed invention or how to achieve it.

Id.

(citing

In re O’Farrell,

853 F.2d

894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988)).

Example 4:

Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd.,

492 F.3d

1350, 83 USPQ2d 1169 (Fed. Cir. 2007), is an example of a chemical case in which

the Federal Circuit found that the claimed invention was not obvious. The claimed

compound was pioglitazone, a member of a class of drugs known as

thiazolidinediones (TZDs) marketed by Takeda as a treatment for Type 2 diabetes.

The

Takeda

case brings together the concept of a “lead

compound” and the obvious-to-try argument.

Alphapharm had filed an Abbreviated New Drug

Application with the Food and Drug Administration, which was a technical act of

infringement of Takeda’s patent. When Takeda brought suit, Alphapharm’s defense

was that Takeda’s patent was invalid due to obviousness

akeda as a treatment for Type 2 diabetes.

The

Takeda

case brings together the concept of a “lead

compound” and the obvious-to-try argument.

Alphapharm had filed an Abbreviated New Drug

Application with the Food and Drug Administration, which was a technical act of

infringement of Takeda’s patent. When Takeda brought suit, Alphapharm’s defense

was that Takeda’s patent was invalid due to obviousness. Alphapharm argued that a

two-step modification – involving homologation and ring-walking – of a known

compound identified as “compound b” would have produced pioglitazone, and that it

was therefore obvious.

The district court found that there would have been

no reason to select compound b as a lead compound. There were a large number of

similar prior art TZD compounds; fifty-four were specifically identified in

Takeda’s prior patent, and the district court observed that “hundreds of millions”

were more generally disclosed. Although the parties agreed that compound b

represented the closest prior art, one reference taught certain disadvantageous

properties associated with compound b, which according to the district court would

have taught the skilled artisan not to select that compound as a lead compound.

The district court found no

prima facie

case of obviousness,

and stated that even if a

prima facie

case had been

established, it would have been overcome in this case in view of the unexpected

lack of toxicity of pioglitazone.

The Federal Circuit affirmed the decision of the

district court, citing the need for a reason to modify a prior art compound. The

Federal Circuit quoted

KSR,

stating:

The

KSR

Court recognized that

“[w]hen 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.”

KSR,

550 U.S. at 421, 82 USPQ2d at 1397. In such

circumstances, “the fact that a combination was obvious to try might show that

it was obvious under

§ 103

.”

Id

hen 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.”

KSR,

550 U.S. at 421, 82 USPQ2d at 1397. In such

circumstances, “the fact that a combination was obvious to try might show that

it was obvious under

§ 103

.”

Id.

That is not the case here. Rather than identify

predictable solutions for antidiabetic treatment, the prior art disclosed a

broad selection of compounds any one of which could have been selected as a

lead compound for further investigation. Significantly, the closest prior art

compound (compound b, the 6-methyl) exhibited negative properties that would

have directed one of ordinary skill in the art away from that compound. Thus,

this case fails to present the type of situation contemplated by the Court when

it stated that an invention may be deemed obvious if it was “obvious to try.”

The evidence showed that it was not obvious to try.

Takeda,

492 F.3d at 1359, 83 USPQ2d at 1176.

Accordingly, Office personnel should recognize that

the obvious to try rationale does not apply when the appropriate factual findings

cannot be made. In

Takeda,

there was a recognized need for

treatment of diabetes. However, there was no finite number of identified,

predictable solutions to the recognized need, and no reasonable expectation of

success. There were numerous known TZD compounds, and although one clearly

represented the closest prior art, its known disadvantages rendered it unsuitable

as a starting point for further research, and taught the skilled artisan away from

its use. Furthermore, even if there had been reason to select compound b, there

had been no reasonable expectation of success associated with the particular

modifications necessary to transform compound b into the claimed compound

pioglitazone. Thus, an obviousness rejection based on an obvious to try rationale

was not appropriate in this situation

esearch, and taught the skilled artisan away from

its use. Furthermore, even if there had been reason to select compound b, there

had been no reasonable expectation of success associated with the particular

modifications necessary to transform compound b into the claimed compound

pioglitazone. Thus, an obviousness rejection based on an obvious to try rationale

was not appropriate in this situation.

Example 5:

The case of

Ortho-McNeil Pharm., Inc. v.

Mylan Labs, Inc.,

520 F.3d 1358, 86 USPQ2d 1196 (Fed. Cir. 2008),

provides another example in which a chemical compound was determined not to be

obvious. The claimed subject matter was topiramate, which is used as an

anti-convulsant.

In the course of working toward a new anti-diabetic

drug, Ortho-McNeil’s scientist had unexpectedly discovered that a reaction

intermediate had anti-convulsant properties. Mylan’s defense of invalidity due to

obviousness rested on an obvious to try argument. However, Mylan did not explain

why it would have been obvious to begin with an anti-diabetic drug precursor,

especially the specific one that led to topiramate, if one had been seeking an

anti-convulsant drug. The district court ruled on summary judgment that

Ortho-McNeil’s patent was not invalid for obviousness.

The Federal Circuit affirmed. The Federal Circuit

pointed out that there was no apparent reason a person of ordinary skill would

have chosen the particular starting compound or the particular synthetic pathway

that led to topiramate as an intermediate. Furthermore, there would have been no

reason to test that intermediate for anticonvulsant properties if treating

diabetes had been the goal. The Federal Circuit recognized an element of

serendipity in this case, which runs counter to the requirement for

predictability

l would

have chosen the particular starting compound or the particular synthetic pathway

that led to topiramate as an intermediate. Furthermore, there would have been no

reason to test that intermediate for anticonvulsant properties if treating

diabetes had been the goal. The Federal Circuit recognized an element of

serendipity in this case, which runs counter to the requirement for

predictability. Summarizing their conclusion with regard to Mylan’s obvious to try

argument, the Federal Circuit stated:

[T]his invention, contrary to Mylan’s

characterization, does not present a finite (and small in the context of the

art) number of options easily traversed to show obviousness. . . .

KSR

posits a situation with a finite, and in the context

of the art, small or easily traversed, number of options that would convince an

ordinarily skilled artisan of obviousness. . . . [T]his clearly is not the

easily traversed, small and finite number of alternatives that

KSR

suggested might support an inference of obviousness.

Id.

at 1364, 86 USPQ2d at 1201.

Thus,

Ortho-McNeil

helps to

clarify the Supreme Court’s requirement in KSR for “a finite number” of

predictable solutions when an obvious to try rationale is applied: under the

Federal Circuit’s case law “finite” means “small or easily traversed” in the

context of the art in question. As taught in

Abbott,

discussed

above, it is essential that the inquiry be placed in the context of the subject

matter at issue, and each case must be decided on its own facts.

Example 6:

In

Bayer Schering Pharma A.G. v. Barr

Labs., Inc.,

575 F.3d 1341, 91 USPQ2d 1569 (Fed. Cir. 2009), the

claimed invention was an oral contraceptive containing micronized drospirenone

marketed as Yasmin

®

. The prior art compound

drospirenone was known to be a poorly water-soluble, acid-sensitive compound with

contraceptive effects. It was also known in the art that micronization improves

the solubility of poorly water soluble drugs

arr

Labs., Inc.,

575 F.3d 1341, 91 USPQ2d 1569 (Fed. Cir. 2009), the

claimed invention was an oral contraceptive containing micronized drospirenone

marketed as Yasmin

®

. The prior art compound

drospirenone was known to be a poorly water-soluble, acid-sensitive compound with

contraceptive effects. It was also known in the art that micronization improves

the solubility of poorly water soluble drugs.

Based on the known acid sensitivity, Bayer had

studied how effectively an enteric-coated drospirenone tablet delivered a

formulation as compared to an intravenous injection of the same formulation to

measure the “absolute bioavailability” of the drug. Bayer added an unprotected

(normal) drospirenone tablet and compared its bioavailability to that of the

enteric-coated formulation and the intravenous delivery. Bayer expected to find

that the enteric-coated tablet would produce a lower bioavailability than an

intravenous injection, while the normal pill would produce an even lower

bioavailability than the enteric-coated tablet. However, they found that despite

observations that drospirenone would quickly isomerize in a highly acidic

environment (supporting the belief that an enteric coating would be necessary to

preserve bioavailability), the normal pill and the enteric-coated pill resulted in

the same bioavailability. Following this study, Bayer developed micronized

drospirenone in a normal pill, the basis for the disputed patent.

The district court found that a person having

ordinary skill in the art would have considered the prior art result that a

structurally related compound, spirorenone, though acid-sensitive, would

nevertheless absorb

in vivo,

would have suggested the same

result for drospirenone

bility. Following this study, Bayer developed micronized

drospirenone in a normal pill, the basis for the disputed patent.

The district court found that a person having

ordinary skill in the art would have considered the prior art result that a

structurally related compound, spirorenone, though acid-sensitive, would

nevertheless absorb

in vivo,

would have suggested the same

result for drospirenone. It also found that while another reference taught that

drospirenone isomerizes

in vitro

when exposed to acid

simulating the human stomach, a person of ordinary skill would have been aware of

the study’s shortcomings, and would have verified the findings as suggested by a

treatise on the science of dosage form design, which would have then showed that

no enteric coating was necessary.

The Federal Circuit held that the patent was invalid

because the claimed formulation was obvious. The Federal Circuit reasoned that the

prior art would have funneled the formulator toward two options. Thus, the

formulator would not have been required to try all possibilities in a field

unreduced by the prior art. The prior art was not vague in pointing toward a

general approach or area of exploration, but rather guided the formulator

precisely to the use of either a normal pill or an enteric-coated pill.

It is important for Office personnel to recognize

that the mere existence of a large number of options does not in and of itself

lead to a conclusion of nonobviousness. Where the prior art teachings lead one of

ordinary skill in the art to a narrower set of options, then that reduced set is

the appropriate one to consider when determining obviousness using an obvious to

try rationale.

Example 7:

The case of

Sanofi-Synthelabo v. Apotex,

Inc.,

550 F.3d 1075, 89 USPQ2d 1370 (Fed. Cir. 2008), also sheds

light on the obvious to try line of reasoning. The claimed compound was

clopidogrel, which is the dextrorotatory isomer of methyl alpha-

5(4,5,6,7-tetrahydro(3,2-c)thienopyridyl)(2-chlorophenyl)-acetate

one to consider when determining obviousness using an obvious to

try rationale.

Example 7:

The case of

Sanofi-Synthelabo v. Apotex,

Inc.,

550 F.3d 1075, 89 USPQ2d 1370 (Fed. Cir. 2008), also sheds

light on the obvious to try line of reasoning. The claimed compound was

clopidogrel, which is the dextrorotatory isomer of methyl alpha-

5(4,5,6,7-tetrahydro(3,2-c)thienopyridyl)(2-chlorophenyl)-acetate. Clopidogrel is

an anti-thrombotic compound used to treat or prevent heart attack or stroke. The

racemate, or mixture of dextrorotatory and levorotatory (D- and L-) isomers of the

compound, was known in the prior art. The two forms had not previously been

separated, and although the mixture was known to have anti-thrombotic properties,

the extent to which each of the individual isomers contributed to the observed

properties of the racemate was not known and was not predictable.

The district court assumed that in the absence of

any additional information, the D-isomer would have been

prima

facie

obvious over the known racemate. However, in view of the

evidence of unpredicted therapeutic advantages of the D-isomer presented in the

case, the district court found that any

prima facie

case of

obviousness had been overcome. At trial, the experts for both parties testified

that persons of ordinary skill in the art could not have predicted the degree to

which the isomers would have exhibited different levels of therapeutic activity

and toxicity. Both parties’ experts also agreed that the isomer with greater

therapeutic activity would most likely have had greater toxicity. Sanofi witnesses

testified that Sanofi’s own researchers had believed that the separation of the

isomers was unlikely to have been productive, and experts for both parties agreed

that it was difficult to separate isomers at the time of the invention

ctivity

and toxicity. Both parties’ experts also agreed that the isomer with greater

therapeutic activity would most likely have had greater toxicity. Sanofi witnesses

testified that Sanofi’s own researchers had believed that the separation of the

isomers was unlikely to have been productive, and experts for both parties agreed

that it was difficult to separate isomers at the time of the invention.

Nevertheless, when Sanofi ultimately undertook the task of separating the isomers,

it found that they had the “rare characteristic of ‘absolute stereoselectivity,’”

whereby the D-isomer provided all of the favorable therapeutic activity but no

significant toxicity, while the L-isomer produced no therapeutic activity but

virtually all of the toxicity. Based on this record, the district court concluded

that Apotex had not met its burden of proving by clear and convincing evidence

that Sanofi’s patent was invalid for obviousness. The Federal Circuit affirmed the

district court’s conclusion.

Office personnel should recognize that even when

only a small number of possible choices exist, the obvious to try line of

reasoning is not appropriate when, upon consideration of all of the evidence, the

outcome would not have been reasonably predictable and the inventor would not have

had a reasonable expectation of success. In

Bayer,

there were

art-based reasons to expect that both the normal pill and the enteric-coated pill

would be therapeutically suitable, even though not all prior art studies were in

complete agreement. Thus, the result obtained was not unexpected. In

Sanofi,

on the other hand, there was strong evidence that

persons of ordinary skill in the art, prior to the separation of the isomers,

would have had no reason to expect that the D-isomer would have such strong

therapeutic advantages as compared with the L-isomer. In other words, the result

in

Sanofi

was unexpected.

Example 8:

In

Rolls-Royce, PLC v. United Tech.

Corp.,

603 F.3d 1325, 95 USPQ2d 1097 (Fed. Cir

he other hand, there was strong evidence that

persons of ordinary skill in the art, prior to the separation of the isomers,

would have had no reason to expect that the D-isomer would have such strong

therapeutic advantages as compared with the L-isomer. In other words, the result

in

Sanofi

was unexpected.

Example 8:

In

Rolls-Royce, PLC v. United Tech.

Corp.,

603 F.3d 1325, 95 USPQ2d 1097 (Fed. Cir. 2010), the Federal

Circuit addressed the obvious to try rationale in the context of a fan blade for

jet engines. The case had arisen out of an interference proceeding. Finding that

the district court had correctly determined that there was no interference-in-fact

because Rolls-Royce’s claims would not have been obvious in light of United’s

application, the Federal Circuit affirmed.

The Federal Circuit described the fan blade of the

count as follows:

Each fan blade has three regions – an inner, an

intermediate, and an outer region. The area closest to the axis of rotation at

the hub is the inner region. The area farthest from the center of the engine

and closest to the casing surrounding the engine is the outer region. The

intermediate region falls in between. The count defines a fan blade with a

swept-forward inner region, a swept-rearward intermediate region, and

forward-leaning outer region.

Id.

at 1328, 95 USPQ2d at 1099.

United had argued that it would have been obvious

for a person of ordinary skill in the art to try a fan blade design in which the

sweep angle in the outer region was reversed as compared with prior art fan blades

from rearward to forward sweep, in order to reduce endwall shock. The Federal

Circuit disagreed with United’s assessment that the claimed fan blade would have

been obvious based on an obvious to try rationale. The Federal Circuit pointed out

that in a proper obvious to try approach to obviousness, the possible options for

solving a problem must have been “known and finite.”

Id.

at

1339, 95 USPQ2d at 1107 (citing

Abbott,

544 F.3d at 1351, 89

USPQ2d at 1171)

hock. The Federal

Circuit disagreed with United’s assessment that the claimed fan blade would have

been obvious based on an obvious to try rationale. The Federal Circuit pointed out

that in a proper obvious to try approach to obviousness, the possible options for

solving a problem must have been “known and finite.”

Id.

at

1339, 95 USPQ2d at 1107 (citing

Abbott,

544 F.3d at 1351, 89

USPQ2d at 1171). In this case, nothing in the prior art would have suggested that

changing the sweep angle as Rolls-Royce had done would have addressed the issue of

endwall shock. Thus, the Federal Circuit concluded that changing the sweep angle

“would not have presented itself as an option at all, let alone an option that

would have been obvious to try.”

Id.

The decision in

Rolls-Royce

is a reminder to Office personnel that the

obvious to try rationale can properly be used to support a conclusion of

obviousness only when the claimed solution would have been selected from a finite

number of potential solutions known to persons of ordinary skill in the art.

Example 9:

The case of

Perfect Web Tech., Inc. v.

InfoUSA, Inc.,

587 F.3d 1324, 1328-29, 92 USPQ2d 1849, 1854 (Fed.

Cir. 2009), provides an example in which the Federal Circuit held that a claimed

method for managing bulk email distribution was obvious on the basis of an obvious

to try argument. In

Perfect Web,

the method required selecting

the intended recipients, transmitting the emails, determining how many of the

emails had been successfully received, and repeating the first three steps if a

pre-determined minimum number of intended recipients had not received the email.

The Federal Circuit affirmed the district court’s

determination on summary judgment that the claimed invention would have been

obvious. Failure to meet a desired quota of email recipients was a recognized

problem in the field of email marketing

s had been successfully received, and repeating the first three steps if a

pre-determined minimum number of intended recipients had not received the email.

The Federal Circuit affirmed the district court’s

determination on summary judgment that the claimed invention would have been

obvious. Failure to meet a desired quota of email recipients was a recognized

problem in the field of email marketing. The prior art had also recognized three

potential solutions: increasing the size of the initial recipient list; resending

emails to recipients who did not receive them on the first attempt; and selecting

a new recipient list and sending emails to them. The last option corresponded to

the fourth step of the invention as claimed.

The Federal Circuit noted that based on “simple

logic,” selecting a new list of recipients was more likely to result in the

desired outcome than resending to those who had not received the email on the

first attempt. There had been no evidence of any unexpected result associated with

selecting a new recipient list, and no evidence that the method would not have had

a reasonable likelihood of success. Thus, the Federal Circuit concluded that, as

required by

KSR,

there were a “finite number of identified,

predictable solutions,” and that the obvious to try inquiry properly led to the

legal conclusion of obviousness.

The Federal Circuit in

Perfect

Web

also discussed the role of common sense in the determination of

obviousness. The district court had cited

KSR

for the

proposition that “[a] person of ordinary skill is also a person of ordinary

creativity, not an automaton,” and found that “the final step [of the claimed

invention] is merely the logical result of common sense application of the maxim

‘try, try again.’” In affirming the district court, the Federal Circuit undertook

an extended discussion of common sense as it has been applied to the obviousness

inquiry, both before and since the

KSR

decision

l is also a person of ordinary

creativity, not an automaton,” and found that “the final step [of the claimed

invention] is merely the logical result of common sense application of the maxim

‘try, try again.’” In affirming the district court, the Federal Circuit undertook

an extended discussion of common sense as it has been applied to the obviousness

inquiry, both before and since the

KSR

decision.

The Federal Circuit pointed out that application of

common sense is not really an innovation in the law of obviousness when it stated,

“Common sense has long been recognized to inform the analysis of obviousness if

explained with sufficient reasoning.”

Perfect Web,

587 F.3d at

1328, 92 USPQ2d at 1853 (emphasis added). The Federal Circuit then provided a

review of a number of precedential cases that inform the understanding of common

sense, including

In re Bozek,

416 F.2d 1385, 1390, 163 USPQ

545, 549 (CCPA 1969) (explaining that a patent examiner may rely on “common

knowledge and common sense of the person of ordinary skill in the art without any

specific hint or suggestion in a particular reference”) and

In re

Zurko,

258 F.3d 1379, 1383, 1385, 59 USPQ2d 1693 at 1695, 1697 (Fed.

Cir. 2001) (clarifying that a factual foundation is needed in order for an

examiner to invoke “good common sense” in a case in which “basic knowledge and

common sense was not based on any evidence in the record”). The Federal Circuit

implicitly acknowledged in

Perfect Web

that the kind of strict

evidence-based teaching, suggestion, or motivation required in

In re

Lee,

277 F.3d 1338, 1344, 61 USPQ2d 1430, 1434 (Fed. Cir. 2002), is

not an absolute requirement for an obviousness rejection in light of the teachings

of

KSR

in which “basic knowledge and

common sense was not based on any evidence in the record”). The Federal Circuit

implicitly acknowledged in

Perfect Web

that the kind of strict

evidence-based teaching, suggestion, or motivation required in

In re

Lee,

277 F.3d 1338, 1344, 61 USPQ2d 1430, 1434 (Fed. Cir. 2002), is

not an absolute requirement for an obviousness rejection in light of the teachings

of

KSR.

The Federal Circuit explained that “[a]t the time [of

the Lee decision], we required the PTO to identify record evidence of a teaching,

suggestion, or motivation to combine references.” However,

Perfect

Web

went on to state that even under

Lee,

common

sense could properly be applied when analyzing evidence relevant to obviousness.

Citing

DyStar Textilfarben GmbH v. C.H. Patrick Co.,

464 F.3d

1356, 80 USPQ2d 1641 (Fed. Cir. 2006), and

In re Kahn,

441 F.3d

977, 78 USPQ2d 1329 (Fed. Cir. 2006), two cases decided shortly before the Supreme

Court’s decision in

KSR,

the Federal Circuit noted that

although “a reasoned explanation that avoids conclusory generalizations” is

required to use common sense, identification of a “specific hint or suggestion in

a particular reference” is not. See also

B/E Aerospace, Inc. v. C&D

Zodiac, Inc.,

962 F.3d 1373, 1380-81, 2020 USPQ2d 10706 (Fed. Cir.

2020) (stating that “the Board’s invocation of common sense was properly

accompanied by reasoned analysis and evidentiary support” to show why it would be

obvious to incorporate a second recess to receive an airplane seat support). But

see

Arendi v. Apple,

832 F.3d 1355, 119 USPQ2d 1822 (Fed. Cir.

2016) (finding that the Board had not provided a reasoned analysis, supported by

the evidence of record, for why “common sense” taught the missing process step).

F

s properly

accompanied by reasoned analysis and evidentiary support” to show why it would be

obvious to incorporate a second recess to receive an airplane seat support). But

see

Arendi v. Apple,

832 F.3d 1355, 119 USPQ2d 1822 (Fed. Cir.

2016) (finding that the Board had not provided a reasoned analysis, supported by

the evidence of record, for why “common sense” taught the missing process step).

F.

Known Work in One Field of Endeavor May Prompt Variations of It for Use

in Either the Same Field or a Different One Based on Design Incentives or Other

Market Forces if the Variations Are Predictable to One of Ordinary Skill in the

Art

To reject a claim based on this rationale, Office personnel must

resolve the

Graham

factual inquiries. Then, Office personnel must

articulate the following:

(1) a finding that the scope and content of the prior art, whether

in the same field of endeavor as that of the applicant’s invention or a

different field of endeavor, included a similar or analogous device (method, or

product);

(2) a finding that there were design incentives or market forces

which would have prompted adaptation of the known device (method, or product);

(3) a finding that the differences between the claimed invention

and the prior art were encompassed in known variations or in a principle known

in the prior art;

(4) a finding that one of ordinary skill in the art, in view of

the identified design incentives or other market forces, could have implemented

the claimed variation of the prior art, and the claimed variation would have

been predictable to one of ordinary skill in the art; and

en the claimed invention

and the prior art were encompassed in known variations or in a principle known

in the prior art;

(4) a finding that one of ordinary skill in the art, in view of

the identified design incentives or other market forces, could have implemented

the claimed variation of the prior art, and the claimed variation would have

been predictable to one of ordinary skill in the art; and

(5) whatever additional findings based on the

Graham

factual inquiries may be necessary, in view of the

facts of the case under consideration, to explain a conclusion of obviousness.

The rationale to support a conclusion that the claimed invention

would have been obvious is that design incentives or other market forces could have

prompted one of ordinary skill in the art to vary the prior art in a predictable

manner to result in the claimed invention. If any of these findings cannot be made,

then this rationale cannot be used to support a conclusion that the claim would have

been obvious to one of ordinary skill in the art.

Example 1:

The fact pattern in

Dann v. Johnston,

425 U.S.

219, 189 USPQ 257 (1976) is set forth above in Example 1 in subsection D.

The Court found that the problem addressed by applicant – the

need to give more detailed breakdown by a category of transactions – was closely

analogous to the task of keeping track of the transaction files of individual

business units.

Id.

at 229, 189 USPQ at 261. Thus, an artisan

in the data processing area would have recognized the similar class of problem and

the known solutions of the prior art and it would have been well within the

ordinary skill level to implement the system in the different environment. The

Court held that “[t]he gap between the prior art and respondent’s system is simply

not so great as to render the system nonobvious to one reasonably skilled in the

art.”

Id.

at 230, 189 USPQ at 261.

Example 2:

The claimed invention in

Leapfrog Enterprises, Inc. v.

Fisher-Price, Inc.,

485 F.3d 1157, 82 USPQ2d 1687 (Fed. Cir

inary skill level to implement the system in the different environment. The

Court held that “[t]he gap between the prior art and respondent’s system is simply

not so great as to render the system nonobvious to one reasonably skilled in the

art.”

Id.

at 230, 189 USPQ at 261.

Example 2:

The claimed invention in

Leapfrog Enterprises, Inc. v.

Fisher-Price, Inc.,

485 F.3d 1157, 82 USPQ2d 1687 (Fed. Cir. 2007)

was directed to a learning device to help young children read phonetically. The

claim read as follows:

An interactive learning device, comprising:

a housing including a plurality of switches;

a sound production device in communication with the switches and

including a processor and a memory;

at least one depiction of a sequence of letters, each letter

being associable with a switch; and

a reader configured to communicate the identity of the depiction

to the processor,

wherein selection of a depicted letter activates an associated

switch to communicate with the processor, causing the sound production device to

generate a signal corresponding to a sound associated with the selected letter,

the sound being determined by a position of the letter in the sequence of

letter.

The court concluded that the claimed invention would have been

obvious in view of the combination of two pieces of prior art, (1) Bevan (which

showed an electro-mechanical toy for phonetic learning), (2) the Super Speak &

Read device (SSR) (an electronic reading toy), and the knowledge of one of

ordinary skill in the art.

The court made clear that there was no technological advance

beyond the skill shown in the SSR device. The court stated that “one of ordinary

skill in the art of children’s learning toys would have found it obvious to

combine the Bevan device with the 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

e

beyond the skill shown in the SSR device. The court stated that “one of ordinary

skill in the art of children’s learning toys would have found it obvious to

combine the Bevan device with the 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. While the SSR only permits generation of a sound corresponding to the first

letter of a word, it does so using electronic means. The combination is thus the

adaptation of an old idea or invention (Bevan) using newer technology that is

commonly available and understood in the art (the SSR).”

The court found that the claimed invention was but a variation on

already known children’s toys. This variation presented no nonobvious advance over

other toys. The court made clear that there was no technological advance beyond

the skill shown in the SSR device. The court found that “[a]ccommodating a prior

art mechanical device that accomplishes that goal to modern electronics would have

been reasonably obvious to one of ordinary skill in designing children’s learning

devices. Applying modern electronics to older mechanical devices has been

commonplace in recent years.”

Example 3:

The claimed invention in

KSR Int'l Co. v.

Teleflex

Inc.,

550 U.S. 398, 82 USPQ2d 1385 (2007), was an adjustable

pedal assembly with a fixed pivot point and an electronic pedal-position sensor

attached to the assembly support. The fixed pivot point meant that the pivot was

not changed as the pedal was adjusted. The placement of the sensor on the assembly

support kept the sensor fixed while the pedal was adjusted.

Conventional gas pedals operated by a mechanical link which

adjusted the throttle based on the travel of the pedal from a set position. The

throttle controlled the combustion process and the available power generated by

the engine

t meant that the pivot was

not changed as the pedal was adjusted. The placement of the sensor on the assembly

support kept the sensor fixed while the pedal was adjusted.

Conventional gas pedals operated by a mechanical link which

adjusted the throttle based on the travel of the pedal from a set position. The

throttle controlled the combustion process and the available power generated by

the engine. Newer cars used computer controlled throttles in which a sensor

detected the motion of the pedal and sent signals to the engine to adjust the

throttle accordingly. At the time of the invention, the marketplace provided a

strong incentive to convert mechanical pedals to electronic pedals, and the prior

art taught a number of methods for doing so. The prior art (Asano) taught an

adjustable pedal with a fixed pivot point with mechanical throttle control. The

prior art (‘936 patent to Byler) taught an electronic pedal sensor which was

placed on a pivot point in the pedal assembly and that it was preferable to detect

the pedal’s position in the pedal mechanism rather than in the engine. The prior

art (Smith) taught that to prevent the wires connecting the sensor to the computer

from chafing and wearing out, the sensor should be put on a fixed part of the

pedal assembly rather than in or on the pedal’s footpad. The prior art (Rixon)

taught an adjustable pedal assembly (sensor in the footpad) with an electronic

sensor for throttle control. There was no prior art electronic throttle control

that was combined with a pedal assembly which kept the pivot point fixed when

adjusting the pedal.

The Court stated that “[t]he proper question to have asked was

whether a pedal designer of ordinary skill, facing the wide range of needs created

by developments in the field of endeavor, would have seen a benefit to upgrading

Asano with a sensor.”

Id.

at 424, 82 USPQ2d at 1399. The Court

found that technological developments in the automotive design would have prompted

a designer to upgrade Asano with an electronic sensor

he proper question to have asked was

whether a pedal designer of ordinary skill, facing the wide range of needs created

by developments in the field of endeavor, would have seen a benefit to upgrading

Asano with a sensor.”

Id.

at 424, 82 USPQ2d at 1399. The Court

found that technological developments in the automotive design would have prompted

a designer to upgrade Asano with an electronic sensor. The next question was where

to attach the sensor. Based on the prior art, a designer would have known to place

the sensor on a nonmoving part of the pedal structure and the most obvious

nonmoving point on the structure from which a sensor can easily detect the pedal’s

position was a pivot point. The Court concluded that it would have been obvious to

upgrade Asano’s fixed pivot point adjustable pedal by replacing the mechanical

assembly for throttle control with an electronic throttle control and to mount the

electronic sensor on the pedal support structure.

Example 4:

The claimed invention in

Ex parte Catan,

83

USPQ2d 1569 (Bd. Pat. App. & Int. 2007), was a consumer electronics device

using bioauthentication to authorize sub-users of an authorized credit account to

place orders over a communication network up to a pre-set maximum sub-credit

limit.

The prior art (Nakano) disclosed a consumer electronics device

like the claimed invention, except that security was provided by a password

authentication device rather than a bioauthentication device. The prior art

(Harada) disclosed that the use of a bioauthentication device (fingerprint sensor)

on a consumer electronics device (remote control) to provide bioauthentication

information (fingerprint) was known in the prior art at the time of the invention.

The prior art (Dethloff) also disclosed that it was known in the art at the time

of the invention to substitute bioauthentication for PIN authentication to enable

a user to access credit via a consumer electronics device

ngerprint sensor)

on a consumer electronics device (remote control) to provide bioauthentication

information (fingerprint) was known in the prior art at the time of the invention.

The prior art (Dethloff) also disclosed that it was known in the art at the time

of the invention to substitute bioauthentication for PIN authentication to enable

a user to access credit via a consumer electronics device.

The Board found that the prior art “shows that one of ordinary

skill in the consumer electronic device art at the time of the invention would

have been familiar with using bioauthentication information interchangeably with

or in lieu of PINs to authenticate users.” The Board concluded that one of

ordinary skill in the art of consumer electronic devices would have found it

obvious to update the prior art password device with the modern bioauthentication

component and thereby gain, predictably, the commonly understood benefits of such

adaptation, that is, a secure and reliable authentication procedure.

G.

Some Teaching, Suggestion, or Motivation in the Prior Art That Would Have

Led One of Ordinary Skill To Modify the Prior Art Reference or To Combine Prior

Art Reference Teachings To Arrive at the Claimed Invention

To reject a claim based on this rationale, Office personnel must

resolve the

Graham

factual inquiries. Then, Office personnel must

articulate the following:

(1) a finding that there was some teaching, suggestion, or

motivation, either in the references themselves or in the knowledge generally

available to one of ordinary skill in the art, to modify the reference or to

combine reference teachings;

(2) a finding that there was reasonable expectation of success;

and

solve the

Graham

factual inquiries. Then, Office personnel must

articulate the following:

(1) a finding that there was some teaching, suggestion, or

motivation, either in the references themselves or in the knowledge generally

available to one of ordinary skill in the art, to modify the reference or to

combine reference teachings;

(2) a finding that there was reasonable expectation of success;

and

(3) whatever additional findings based on the

Graham

factual inquiries may be necessary, in view of the

facts of the case under consideration, to explain a conclusion of obviousness.

The rationale to support a conclusion that the claim would have

been obvious is that "a person of ordinary skill in the art would have been motivated

to combine the prior art to achieve the claimed invention and whether there would

have been a reasonable expectation of success in doing so."

DyStar

Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co.,

464 F.3d

1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006). If any of these findings cannot be

made, then this rationale cannot be used to support a conclusion that the claim would

have been obvious to one of ordinary skill in the art.

The courts have made clear that the teaching, suggestion, or

motivation test is flexible and an explicit suggestion to combine the prior art is

not necessary. The motivation to combine may be implicit and may be found in the

knowledge of one of ordinary skill in the art, or, in some cases, from the nature of

the problem to be solved.

Id.

at 1366, 80 USPQ2d at 1649. “[A]n

implicit motivation to combine exists not only when a suggestion may be gleaned from

the prior art as a whole, but when the ‘improvement’ is technology-independent and

the combination of references results in a product or process that is more desirable,

for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more

durable, or more efficient

at 1366, 80 USPQ2d at 1649. “[A]n

implicit motivation to combine exists not only when a suggestion may be gleaned from

the prior art as a whole, but when the ‘improvement’ is technology-independent and

the combination of references results in a product or process that is more desirable,

for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more

durable, or more efficient. Because the desire to enhance commercial opportunities by

improving a product or process is universal—and even common-sensical—we have held

that there exists in these situations a motivation to combine prior art references

even absent any hint of suggestion in the references themselves. In such situations,

the proper question is whether the ordinary artisan possesses knowledge and skills

rendering him

capable

of combining the prior art references.”

Id.

at 1368, 80 USPQ2d at 1651.