Examination Guidelines for Determining Obviousness Under 35 U.S.C. 103

[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.]

35 U.S.C. 103

Conditions for patentability; non-obvious subject matter.

A patent for a claimed invention may not be obtained,

notwithstanding that the claimed invention is not identically disclosed as set forth in

section

102

, if the differences between the claimed invention and the

prior art are such that the claimed invention as a whole would have been obvious before

the effective filing date of the claimed invention to a person having ordinary skill in

the art to which the claimed invention pertains. Patentability shall not be negated by

the manner in which the invention was made.

Pre-AIA 35 U.S.C. 103

Conditions for patentability; nonobvious subject matter.

ntion and the

prior art are such that the claimed invention as a whole would have been obvious before

the effective filing date of the claimed invention to a person having ordinary skill in

the art to which the claimed invention pertains. Patentability shall not be negated by

the manner in which the invention was made.

Pre-AIA 35 U.S.C. 103

Conditions for patentability; nonobvious subject matter.

(a) A patent may not be obtained though the invention

is not identically disclosed or described as set forth in

section 102

,

if the differences between the subject matter sought to be patented and the prior

art are such that the subject matter as a whole would have been obvious at the

time the invention was made to a person having ordinary skill in the art to which

said subject matter pertains. Patentability shall not be negatived by the manner

in which the invention was made.

*****

EXAMINATION GUIDELINES FOR DETERMINING OBVIOUSNESS UNDER 35 U.S.C. 103

These guidelines are intended to assist Office personnel to make a

proper determination of obviousness under

35 U.S.C. 103

, and to provide an

appropriate supporting rationale in view of the decision by the Supreme Court in

KSR International Co. v. Teleflex Inc. (KSR),

550 U.S. 398, 82

USPQ2d 1385 (2007). The guidelines are based on the Office’s current understanding of

the law, and are believed to be fully consistent with the binding precedent of the

Supreme Court. The

KSR

decision reinforced earlier decisions that

validated a more flexible approach to providing reasons for obviousness. However, the

Supreme Court’s pronouncement in

KSR

overruled cases such as

In re Lee,

277 F.3d 1338, 61 USPQ2d 1430 (Fed. Cir. 2002), insofar

as those cases require record evidence of an express reason to modify the prior art

nt with the binding precedent of the

Supreme Court. The

KSR

decision reinforced earlier decisions that

validated a more flexible approach to providing reasons for obviousness. However, the

Supreme Court’s pronouncement in

KSR

overruled cases such as

In re Lee,

277 F.3d 1338, 61 USPQ2d 1430 (Fed. Cir. 2002), insofar

as those cases require record evidence of an express reason to modify the prior art. As

the Federal Circuit has explained:

At the time [of the decision in

In re

Lee

], we required the PTO to identify record evidence of a teaching,

suggestion, or motivation to combine references because “[o]mission of a relevant

factor required by precedent is both legal error and arbitrary agency action.”

However, this did not preclude examiners from employing common sense. More recently

[in

DyStar Textilfarben GmbH v. C.H. Patrick Co.,

464 F.3d 1356,

1366 (Fed. Cir. 2006)], we explained that use of common sense does not require a

“specific hint or suggestion in a particular reference,” only a reasoned explanation

that avoids conclusory generalizations.

Perfect Web Technologies, Inc. v. InfoUSA,

Inc.,

587 F.3d 1324, 1329, 92 USPQ2d 1849, 1854 (Fed. Cir. 2009) (citations

omitted).

In another case, the Federal Circuit also stated

that:

“… we conclude that while ‘common sense’ can be

invoked, even potentially to supply a limitation missing from the prior art, it must

still be supported by evidence and a reasoned explanation....[T]his is particularly

true where the missing limitation goes to the heart of an invention.”

Arendi v. Apple,

832 F.3d 1355, 1363,

119 USPQ2d 1822, 1827 (Fed. Cir. 2016).

These guidelines do not constitute substantive rule making and hence do

not have the force and effect of law. They have been developed as a matter of internal

Office management and are not intended to create any right or benefit, substantive or

procedural, enforceable by any party against the Office. Rejections continue to be based

upon the substantive law, and it is these rejections that are appealable

guidelines do not constitute substantive rule making and hence do

not have the force and effect of law. They have been developed as a matter of internal

Office management and are not intended to create any right or benefit, substantive or

procedural, enforceable by any party against the Office. Rejections continue to be based

upon the substantive law, and it is these rejections that are appealable. Consequently,

any failure by Office personnel to follow the guidelines is neither appealable nor

petitionable.

I.

THE

KSR

DECISION AND PRINCIPLES OF THE LAW OF

OBVIOUSNESS

The Supreme Court in

KSR

reaffirmed the familiar

framework for determining obviousness as set forth in

Graham v. John Deere

Co

., 383 U.S. 1, 148 USPQ 459 (1966), but stated that the Federal

Circuit had erred by applying the teaching-suggestion-motivation (TSM) test in an

overly rigid and formalistic way.

KSR,

550 U.S. at 404, 82 USPQ2d

at 1391. Specifically, the Supreme Court stated that the Federal Circuit had erred in

four ways: (1) “by holding that courts and patent examiners should look only to the

problem the patentee was trying to solve ”

(Id.

at 420, 82 USPQ2d

at 1397); (2) by assuming “that a person of ordinary skill attempting to solve a

problem will be led only to those elements of prior art designed to solve the same

problem”

(Id.);

(3) by concluding “that a patent claim cannot be

proved obvious merely by showing that the combination of elements was ‘obvious to

try’”

(Id.

at 421, USPQ2d at 1397); and (4) by overemphasizing

“the risk of courts and patent examiners falling prey to hindsight bias” and as a

result applying “[r]igid preventative rules that deny factfinders recourse to common

sense”

(Id.)

. See also

Novartis Pharms. Corp. v.

West-Ward Pharms. Int'l Ltd.,

923 F.3d 1051, 1059, 2019 USPQ2d 171676

(Fed. Cir. 2019);

Apple Inc. v. Samsung Elecs. Co.,

839 F.3d 1034,

1047-48, 120 USPQ2d 1400, 1410 (Fed. Cir. 2016); and

Aventis Pharma S.A. v.

Hospira, Inc.,

675 F.3d 1324, 1332, 102 USPQ2d 1445, 1449 (Fed. Cir.

2012)

id preventative rules that deny factfinders recourse to common

sense”

(Id.)

. See also

Novartis Pharms. Corp. v.

West-Ward Pharms. Int'l Ltd.,

923 F.3d 1051, 1059, 2019 USPQ2d 171676

(Fed. Cir. 2019);

Apple Inc. v. Samsung Elecs. Co.,

839 F.3d 1034,

1047-48, 120 USPQ2d 1400, 1410 (Fed. Cir. 2016); and

Aventis Pharma S.A. v.

Hospira, Inc.,

675 F.3d 1324, 1332, 102 USPQ2d 1445, 1449 (Fed. Cir.

2012).

In

KSR,

the Supreme Court particularly

emphasized “the need for caution in granting a patent based on the combination of

elements found in the prior art,”

Id.

at 415, 82 USPQ2d at 1395,

and discussed circumstances in which a patent might be determined to be obvious.

Importantly, the Supreme Court reaffirmed principles based on its precedent that

“[t]he combination of familiar elements according to known methods is likely to be

obvious when it does no more than yield predictable results.”

Id.

at 415-16, 82 USPQ2d at 1395. The Supreme Court stated that there are “[t]hree cases

decided after

Graham

[that] illustrate this doctrine.”

Id.

at 416, 82 USPQ2d at 1395. (1) “In

United States

v. Adams,

. . . [t]he Court recognized that when a patent claims a

structure already known in the prior art that is altered by the mere substitution of

one element for another known in the field, the combination must do more than yield a

predictable result.”

Id.

(2) “In

Anderson’s-Black Rock,

Inc. v. Pavement Salvage Co.,

. . . [t]he two [pre-existing elements] in

combination did no more than they would in separate, sequential operation.”

Id.

at 416-17, 82 USPQ2d at 1395. (3) “[I]n

Sakraida

v. AG Pro, Inc.,

the Court derived . . . the conclusion that when a

patent simply arranges old elements with each performing the same function it had

been known to perform and yields no more than one would expect from such an

arrangement, the combination is obvious.”

Id.

at 417, 82 USPQ2d at

1395-96 (Internal quotations omitted.)

ial operation.”

Id.

at 416-17, 82 USPQ2d at 1395. (3) “[I]n

Sakraida

v. AG Pro, Inc.,

the Court derived . . . the conclusion that when a

patent simply arranges old elements with each performing the same function it had

been known to perform and yields no more than one would expect from such an

arrangement, the combination is obvious.”

Id.

at 417, 82 USPQ2d at

1395-96 (Internal quotations omitted.). The principles underlining these cases are

instructive when the question is whether a patent application claiming the

combination of elements of prior art would have been obvious. The Supreme Court

further stated that:

When a work is available in one field of endeavor, design

incentives and other market forces can prompt variations of it, either in the same

field or a different one. If a person of ordinary skill can implement a

predictable variation,

§ 103

likely bars its

patentability. For the same reason, if a technique has been used to improve one

device, and a person of ordinary skill in the art would recognize that it would

improve similar devices in the same way, using the technique is obvious unless its

actual application is beyond his or her skill.

Id.

at 417, 82

USPQ2d at 1396.

When considering obviousness of a combination of known elements,

the operative question is thus “whether the improvement is more than the predictable

use of prior art elements according to their established functions.”

Id.

The Supreme Court’s flexible approach to the

obviousness inquiry is reflected in numerous pre-

KSR

decisions;

see

MPEP §

2144

. That section provides many lines of reasoning to

support a determination of obviousness based upon earlier legal precedent that had

condoned the use of particular examples of what may be considered common sense or

ordinary routine practice (e.g., making integral, changes in shape, making

adjustable). Thus, the type of reasoning sanctioned by the opinion in KSR has long

been part of the patent examination process.

II.

THE BASIC FACTUAL INQUIRIES OF

GRAHAM v. JOHN DEERE CO

obviousness based upon earlier legal precedent that had

condoned the use of particular examples of what may be considered common sense or

ordinary routine practice (e.g., making integral, changes in shape, making

adjustable). Thus, the type of reasoning sanctioned by the opinion in KSR has long

been part of the patent examination process.

II.

THE BASIC FACTUAL INQUIRIES OF

GRAHAM v. JOHN DEERE CO.

An invention that would have been obvious to a person of ordinary

skill at the relevant time is not patentable. See

35 U.S.C.

103

or

pre-AIA 35 U.S.C. 103(a)

.  As

reiterated by the Supreme Court in

KSR,

the framework for the

objective analysis for determining obviousness under

35 U.S.C. 103

is stated in

Graham v. John Deere Co.,

383 U.S. 1, 148 USPQ 459

(1966). Obviousness is a question of law based on underlying factual inquiries. The

factual inquiries enunciated by the Court are as follows:

(A) Determining the scope and content of the prior art;

(B) Ascertaining the differences between the claimed invention and

the prior art; and

(C) Resolving the level of ordinary skill in the pertinent

art.

Objective evidence relevant to the issue of obviousness must be

evaluated by Office personnel.

Id.

at 17-18, 148 USPQ at 467. Such

evidence, sometimes referred to as “secondary considerations,” may include evidence

of commercial success, long-felt but unsolved needs, failure of others, and

unexpected results. The evidence may be included in the specification as filed,

accompany the application on filing, or be provided in a timely manner at some other

point during the prosecution. The weight to be given any objective evidence is

determined on a case-by-case basis. The mere fact that an applicant has presented

evidence does not mean that the evidence is dispositive of the issue of

obviousness.

The question of obviousness must be resolved on the basis of the

factual inquiries set forth above

filing, or be provided in a timely manner at some other

point during the prosecution. The weight to be given any objective evidence is

determined on a case-by-case basis. The mere fact that an applicant has presented

evidence does not mean that the evidence is dispositive of the issue of

obviousness.

The question of obviousness must be resolved on the basis of the

factual inquiries set forth above. While each case is different and must be decided

on its own facts, these factual inquiries, as well as secondary considerations when

present, must be analyzed. The

Graham

factors were reaffirmed and

relied upon by the Supreme Court in its consideration and determination of

obviousness in the fact situation presented in

KSR,

550 U.S. at

406-07, 82 USPQ2d at 1391 (2007). The Supreme Court has utilized the

Graham

factors in each of its obviousness decisions since

Graham.

See

Sakraida v. Ag Pro, Inc.,

425

U.S. 273, 189 USPQ 449,

reh’g denied,

426 U.S. 955 (1976);

Dann v. Johnston,

425 U.S. 219, 189 USPQ 257 (1976); and

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

396 U.S.

57, 163 USPQ 673 (1969). As stated by the Supreme Court in

KSR,

“While the sequence of these questions might be reordered in any particular case, the

[

Graham

] factors continue to define the inquiry that

controls.”

KSR,

550 U.S. at 407, 82 USPQ2d at 1391.

Office Personnel As Factfinders

Office personnel fulfill the critical role of factfinder when

resolving the

Graham

inquiries. It must be remembered that

while the ultimate determination of obviousness is a legal conclusion, the

underlying

Graham

inquiries are factual. When making an

obviousness rejection, Office personnel must therefore ensure that the written

record includes findings of fact concerning the state of the art and the teachings

of the references applied

ole of factfinder when

resolving the

Graham

inquiries. It must be remembered that

while the ultimate determination of obviousness is a legal conclusion, the

underlying

Graham

inquiries are factual. When making an

obviousness rejection, Office personnel must therefore ensure that the written

record includes findings of fact concerning the state of the art and the teachings

of the references applied. In certain circumstances, it may also be important to

include explicit findings as to how a person of ordinary skill would have

understood prior art teachings, or what a person of ordinary skill would have

known or could have done. Factual findings made by Office personnel are the

necessary underpinnings to establish obviousness.

Once the findings of fact are articulated, Office personnel must

provide an explanation to support an obviousness rejection under

35 U.S.C.

103

.

35 U.S.C. 132

requires that

the applicant be notified of the reasons for the rejection of the claim so that

the applicant can decide how best to proceed. Clearly setting forth findings of

fact and the rationale(s) to support a rejection in an Office action leads to the

prompt resolution of issues pertinent to patentability.

In short, the focus when making a determination of obviousness

should be on what a person of ordinary skill in the pertinent art would have known

at the relevant time, and on what such a person would have reasonably expected to

have been able to do in view of that knowledge. This is so regardless of whether

the source of that knowledge and ability was documentary prior art, general

knowledge in the art, or common sense. What follows is a discussion of the

Graham

factual inquiries.

A.

Determining the Scope and Content of the Prior Art

In determining the scope and content of the prior art, Office

personnel must first obtain a thorough understanding of the invention disclosed

and claimed in the application under examination by reading the specification,

including the claims, to understand what has been invented. See

MPEP §

904

is a discussion of the

Graham

factual inquiries.

A.

Determining the Scope and Content of the Prior Art

In determining the scope and content of the prior art, Office

personnel must first obtain a thorough understanding of the invention disclosed

and claimed in the application under examination by reading the specification,

including the claims, to understand what has been invented. See

MPEP §

904

. The scope of the claimed invention must be

clearly determined by giving the claims the “broadest reasonable interpretation

consistent with the specification.” See

Phillips v. AWH

Corp.,

415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005)

and

MPEP

§ 2111

. Once the scope of the claimed invention is

determined, Office personnel must then determine what to search for and where

to search.

1.

What To Search For:

The search should cover the claimed subject matter and

should also cover the disclosed features which might reasonably be expected

to be claimed. See

MPEP § 904.02

. Although a

rejection need not be based on a teaching or suggestion to combine, a

preferred search will be directed to finding references that provide such a

teaching or suggestion if they exist.

2.

Where To Search:

Office personnel should continue to follow the general

search guidelines set forth in

MPEP § 904

to

§ 904.03

regarding search of the prior art.

Office personnel are reminded that, for purposes of

35 U.S.C.

103

, prior art can be either in the field of the

inventor’s endeavor or be reasonably pertinent to the particular problem

with which the inventor was concerned. See

MPEP §

2141.01(a)

for a discussion of analogous art and

MPEP §

1504.03

for a discussion of analogous art for

design applications. Furthermore, prior art that is in a field of endeavor

other than that of the inventor (as noted by the Court in

KSR,

“[w]hen a work is available in one field of

endeavor, design incentives and other market forces can prompt variations of

it, either in the same field or a

different one

,” 550

U.S

scussion of analogous art and

MPEP §

1504.03

for a discussion of analogous art for

design applications. Furthermore, prior art that is in a field of endeavor

other than that of the inventor (as noted by the Court in

KSR,

“[w]hen a work is available in one field of

endeavor, design incentives and other market forces can prompt variations of

it, either in the same field or a

different one

,” 550

U.S. at 417, 82 USPQ2d at 1396 (emphasis added)), or solves a problem which

is different from that which the inventor was trying to solve, may also be

considered for the purposes of

35 U.S.C. 103

. (The

Court in

KSR

stated that “[t]he first error…in this case

was…holding that courts and patent examiners should look only to the problem

the patentee was trying to solve. The Court of Appeals failed to recognize

that the problem motivating the patentee may be only one of many addressed

by the patent’s subject matter…The second error [was]…that a person of

ordinary skill attempting to solve a problem will be led only to those

elements of prior art designed to solve the same problem.” 550 U.S. at 420,

82 USPQ2d at 1397. Federal Circuit case law prior to the Supreme Court’s

decision in

KSR

is generally in accord with these

statements by the

KSR

Court. See e.g.,

In re

Dillon,

919 F.2d 688, 693, 16 USPQ2d 1897, 1902 (Fed. Cir.

1990)

(en banc)

(“[I]t is not necessary in order to

establish a

prima facie

case of obviousness that both a

structural similarity between a claimed and prior art compound (or a key

component of a composition) be shown and that there be a suggestion in or

expectation from

the prior art

that the claimed compound or

composition will have the same or a similar utility

as one newly

discovered by applicant

”) (emphasis added);

In re

Lintner,

458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972)

(“The fact that appellant uses sugar for a different purpose does not alter

the conclusion that its use in a prior art composition would be

prima facie

obvious from the purpose disclosed in the

references.”)

imed compound or

composition will have the same or a similar utility

as one newly

discovered by applicant

”) (emphasis added);

In re

Lintner,

458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972)

(“The fact that appellant uses sugar for a different purpose does not alter

the conclusion that its use in a prior art composition would be

prima facie

obvious from the purpose disclosed in the

references.”).

For a discussion of what constitutes prior art, see

MPEP §

901

to

§ 901.06(d)

and

§

2121

to

§ 2129

. See

MPEP §

2141.01(a)

for a discussion of analogous art and

MPEP §

1504.03

for a discussion of analogous art for

design applications.

B.

Ascertaining the Differences Between the Claimed Invention and the

Prior Art

Ascertaining the differences between the claimed invention

and the prior art requires interpreting the claim language, see

MPEP §

2111

, and considering both the invention and the

prior art as a whole. See

MPEP § 2141.02

.

C.

Resolving the Level of Ordinary Skill in the Art

Any obviousness rejection should include, either explicitly

or implicitly in view of the prior art applied, an indication of the level of

ordinary skill. See

MPEP § 2141.03

, subsection II,

regarding implicit indication of the level of ordinary skill. A finding as to

the level of ordinary skill may be used as a partial basis for a resolution of

the issue of obviousness.

The person of ordinary skill in the art is a hypothetical

person who is presumed to have known the relevant art at the relevant time.

Factors that may be considered in determining the level of ordinary skill in

the art may include: (1) “type of problems encountered in the art;” (2) “prior

art solutions to those problems;” (3) “rapidity with which innovations are

made;” (4) “sophistication of the technology; and” (5) “educational level of

active workers in the field.”

In re GPAC,

57 F.3d 1573,

1579, 35 USPQ2d 1116, 1121 (Fed. Cir. 1995). “In a given case, every factor may

not be present, and one or more factors may predominate.”

Id.

See also

Custom Accessories, Inc. v

t;” (2) “prior

art solutions to those problems;” (3) “rapidity with which innovations are

made;” (4) “sophistication of the technology; and” (5) “educational level of

active workers in the field.”

In re GPAC,

57 F.3d 1573,

1579, 35 USPQ2d 1116, 1121 (Fed. Cir. 1995). “In a given case, every factor may

not be present, and one or more factors may predominate.”

Id.

See also

Custom Accessories, Inc. v.

Jeffrey-Allan Indust., Inc.,

807 F.2d 955, 962, 1 USPQ2d 1196,

1201 (Fed. Cir. 1986);

Environmental Designs, Ltd. v. Union Oil

Co.,

713 F.2d 693, 696, 218 USPQ 865, 868 (Fed. Cir. 1983).

“A person of ordinary skill in the art is also a person of

ordinary creativity, not an automaton.”

KSR,

550 U.S. at 421,

82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to

fit the teachings of multiple patents together like pieces of a

puzzle.”

Id.

at 420, 82 USPQ2d at 1397. Office personnel

may also take into account “the inferences and creative steps that a person of

ordinary skill in the art would employ.”

Id.

at 418, 82

USPQ2d at 1396.

In addition to the factors above, Office personnel may rely

on their own technical expertise to describe the knowledge and skills of a

person of ordinary skill in the art. The Federal Circuit has stated that

examiners and administrative patent judges on the Board are “persons of

scientific competence in the fields in which they work” and that their findings

are “informed by their scientific knowledge, as to the meaning of prior art

references to persons of ordinary skill in the art.”

In re

Berg,

320 F.3d 1310, 1315, 65 USPQ2d 2003, 2007 (Fed. Cir. 2003).

In addition, examiners “are assumed to have some expertise in interpreting the

references and to be familiar from their work with the level of skill in the

art .”

PowerOasis, Inc. v. T-Mobile USA, Inc.,

522 F.3d

1299, 86 USPQ2d 1385 (Fed. Cir. 2008) (quoting

Am. Hoist & Derrick

Co. v. Sowa & Sons,

725 F.2d 1350, 1360, 220 USPQ 763, 770

(Fed. Cir. 1984). See

MPEP § 2141.03

for a

discussion of the level of ordinary skill

“are assumed to have some expertise in interpreting the

references and to be familiar from their work with the level of skill in the

art .”

PowerOasis, Inc. v. T-Mobile USA, Inc.,

522 F.3d

1299, 86 USPQ2d 1385 (Fed. Cir. 2008) (quoting

Am. Hoist & Derrick

Co. v. Sowa & Sons,

725 F.2d 1350, 1360, 220 USPQ 763, 770

(Fed. Cir. 1984). See

MPEP § 2141.03

for a

discussion of the level of ordinary skill.

III.

RATIONALES TO SUPPORT REJECTIONS UNDER 35 U.S.C. 103

Once the

Graham

factual inquiries are resolved,

Office personnel must determine whether the claimed invention would have been obvious as

of the relevant time to one of ordinary skill in the art.

The obviousness analysis cannot be confined by . . . overemphasis on

the importance of published articles and the explicit content of issued

patents. . . . . In many fields it may be that there is little discussion of obvious

techniques or combinations, and it often may be the case that market demand, rather

than scientific literature, will drive design trends.

KSR,

550 U.S.

at 419, 82 USPQ2d at 1396.

Prior art is not limited just to the references being applied, but

includes the understanding of one of ordinary skill in the art. The prior art reference

(or references when combined) need not teach or suggest all the claim limitations.

However, Office personnel must explain why the difference(s) between the prior art and

the claimed invention would have been obvious to one of ordinary skill in the art. The

“mere existence of differences between the prior art and an invention does not establish

the invention’s nonobviousness.”

Dann v. Johnston,

425 U.S. 219, 230,

189 USPQ 257, 261 (1976). The gap between the prior art and the claimed invention may

not be “so great as to render the [claim] nonobvious to one reasonably skilled in the

art.”

Id.

In determining obviousness, neither the particular

motivation to make the claimed invention nor the problem the inventor is solving

controls

tablish

the invention’s nonobviousness.”

Dann v. Johnston,

425 U.S. 219, 230,

189 USPQ 257, 261 (1976). The gap between the prior art and the claimed invention may

not be “so great as to render the [claim] nonobvious to one reasonably skilled in the

art.”

Id.

In determining obviousness, neither the particular

motivation to make the claimed invention nor the problem the inventor is solving

controls. The proper analysis is whether the claimed invention would have been obvious

as of the relevant time to one of ordinary skill in the art after consideration of all

the facts. See

35 U.S.C. 103

or

pre-AIA 35 U.S.C.

103(a)

. Factors other than the disclosures of the cited prior art

may provide a basis for concluding that it would have been obvious to one of ordinary

skill in the art to bridge the gap. The rationales discussed below outline reasoning

that may be applied to find obviousness in such cases.

If the search of the prior art and the resolution of the

Graham

factual inquiries reveal that an obviousness rejection may

be made using the familiar teaching-suggestion-motivation (TSM) rationale, then such a

rejection is appropriate. Although the Supreme Court in

KSR

cautioned

against an overly rigid application of TSM, it also recognized that TSM was one of a

number of valid rationales that could be used to determine obviousness. (According to

the Supreme Court, establishment of the TSM approach to the question of obviousness

“captured a helpful insight.” 550 U.S. at 418, 82 USPQ2d at 1396 (citing

In re

Bergel,

292 F.2d 955, 956-57, 130 USPQ 206, 207-208 (1961)). Furthermore,

the Court explained that “[t]here is no necessary inconsistency between the idea

underlying the TSM test and the

Graham

analysis.” 550 U.S. at 419, 82

USPQ2d at 1396. The Supreme Court also commented that the Federal Circuit “no doubt has

applied the test in accord with these principles [set forth in

KSR

]

in many cases.”

Id

Bergel,

292 F.2d 955, 956-57, 130 USPQ 206, 207-208 (1961)). Furthermore,

the Court explained that “[t]here is no necessary inconsistency between the idea

underlying the TSM test and the

Graham

analysis.” 550 U.S. at 419, 82

USPQ2d at 1396. The Supreme Court also commented that the Federal Circuit “no doubt has

applied the test in accord with these principles [set forth in

KSR

]

in many cases.”

Id.

Office personnel should also consider whether one

or more of the other rationales set forth below supports a conclusion of obviousness.

The Court in

KSR

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

.

KSR,

550 U.S. at 415-21, 82 USPQ2d at 1395-97. Note that the list

of rationales provided below is not intended to be an all-inclusive list. Other

rationales to support a conclusion of obviousness may be relied upon by Office

personnel. Consistent with

KSR,

the Federal Circuit stated that the

obviousness analysis is not “confined by a formalistic conception of the words teaching,

suggestion, and motivation.”

Intel Corp. v. Qualcomm Inc.,

21 F.4th

784, 795, 2021 USPQ2d 1259 (Fed. Cir. 2021) (quoting

KSR,

550 U.S. at

419, 82 USPQ2d at 1396). See also

In re Ethicon, Inc.,

844 F.3d 1344,

1350, 121 USPQ2d 1139, 1143 (Fed. Cir. 2017) (recalling that the Supreme Court has

instructed decisionmakers to “apply ‘an expansive and flexible approach’ to

obviousness”) (quoting

KSR,

550 U.S. at 415, 82 USPQ2d at 1395).

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

”) (quoting

KSR,

550 U.S. at 415, 82 USPQ2d at 1395).

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.’”

KSR,

550 U.S. at 418,

82 USPQ2d at 1396. See also

Adapt Pharma Operations Ltd. v. Teva Pharms. USA,

Inc.,

25 F.4th 1354, 1365, 2022 USPQ2d 144 (Fed. Cir. 2022) (stating that a

determination of obviousness “requires ‘identify[ing] 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’” (quoting

KSR,

550 U.S. at 418, 82 USPQ2d

at 1395). 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

pectation 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.

See

MPEP § 2143

for a discussion of the rationales listed above

along with examples illustrating how the cited rationales may be used to support a

finding of obviousness. See also

MPEP § 2144

-

§ 2144.09

for

additional guidance regarding support for obviousness determinations.

IV.

APPLICANT’S REPLY

Once Office personnel have issued a rejection that establishes the

Graham

factual findings and concludes, in view of the relevant

evidence of record at that time, that the claimed invention would have been obvious as

of the relevant time, the burden then shifts to the applicant to (A) show that the

Office erred in these findings or (B) provide other evidence to show that the claimed

subject matter would have been nonobvious.

37 CFR 1.111(b)

requires applicant

to distinctly and specifically point out the supposed errors in the Office’s action and

reply to every ground of objection and rejection in the Office action. The reply must

present arguments pointing out the specific distinction believed to render the claims

patentable over any applied references.

If an applicant disagrees with any factual findings by the Office, an

effective traverse of a rejection based wholly or partially on such findings must

include a reasoned statement explaining why the applicant believes the Office has erred

substantively as to the factual findings

t arguments pointing out the specific distinction believed to render the claims

patentable over any applied references.

If an applicant disagrees with any factual findings by the Office, an

effective traverse of a rejection based wholly or partially on such findings must

include a reasoned statement explaining why the applicant believes the Office has erred

substantively as to the factual findings. A mere statement or argument that the Office

has not established a

prima facie

case of obviousness or that the

Office’s reliance on common knowledge is unsupported by documentary evidence will not be

considered substantively adequate to rebut the rejection or an effective traverse of the

rejection under

37 CFR

1.111(b)

. Office personnel addressing this situation may repeat

the rejection made in the prior Office action and make the next Office action final. See

MPEP §

706.07(a)

.

An applicant’s reply could also establish that a

disclosure relied on in an obviousness rejection is not in fact prior art in view of a

35 U.S.C.

102(b)

exception, or that subject matter, although prior art, is

disqualified for use in an obviousness rejection in view of

pre-AIA 35 U.S.C.

103(c)

. See

MPEP §§ 2146

,

2153.01

and

2154.02

. See also

MPEP §

2155

regarding affidavits or declarations under

37 CFR

1.130

to overcome prior art rejections.

V.

CONSIDERATION OF APPLICANT’S REBUTTAL EVIDENCE

Office personnel should consider all rebuttal evidence that is timely

presented by the applicants when reevaluating any obviousness determination. Rebuttal

evidence may include evidence of “secondary considerations,” such as “commercial

success, long felt but unsolved needs, [and] failure of others”

(Graham v. John

Deere Co.,

383 U.S. at 17, 148 USPQ at 467), and may also include evidence

of unexpected results. As set forth above, Office personnel must articulate findings of

fact that support the rationale relied upon in an obviousness rejection. As a result,

applicants are likely to submit evidence to rebut the fact finding made by Office

personnel

ut unsolved needs, [and] failure of others”

(Graham v. John

Deere Co.,

383 U.S. at 17, 148 USPQ at 467), and may also include evidence

of unexpected results. As set forth above, Office personnel must articulate findings of

fact that support the rationale relied upon in an obviousness rejection. As a result,

applicants are likely to submit evidence to rebut the fact finding made by Office

personnel. For example, in the case of a claim to a combination, applicants may submit

evidence or argument to demonstrate that:

(A) one of ordinary skill in the art could not have combined the

claimed elements by known methods (e.g., due to technological difficulties);

(B) the elements in combination do not merely perform the function

that each element performs separately; or

(C) the results of the claimed combination were unexpected.

Once the applicant has presented rebuttal evidence, Office personnel

should reconsider any initial obviousness determination in view of the entire record.

See, e.g.,

In re Piasecki,

745 F.2d 1468, 1472, 223 USPQ 785, 788

(Fed. Cir. 1984);

In re Eli Lilly & Co.,

902 F.2d 943, 945, 14

USPQ2d 1741, 1743 (Fed. Cir. 1990). All the rejections of record and proposed rejections

and their bases should be reviewed to confirm their continued viability. The Office

action should clearly communicate the Office’s findings and conclusions, articulating

how the conclusions are supported by the findings. The procedures set forth in

MPEP §

706.07(a)

are to be followed in determining whether an action

may be made final.

See

MPEP

§ 2145

concerning consideration of applicant’s rebuttal

evidence. See also

MPEP §

716

to

§ 716.10

regarding affidavits or

declarations filed under

37 CFR 1.132

for purposes of

traversing grounds of rejection.