Patent Examination Process

I.

DETERMINE WHAT INVENTION IS SOUGHT TO BE PATENTED

It is essential that patent applicants obtain a prompt yet

complete examination of their applications. Under the principles of compact prosecution,

each claim should be reviewed for compliance with every statutory requirement for

patentability in the initial review of the application, even if one or more claims are

found to be deficient with respect to some statutory requirement. Thus, examiners should

state all reasons and bases for rejecting claims in the first Office action.

Deficiencies should be explained clearly, particularly when they serve as a basis for a

rejection. Whenever practicable, examiners and patent reexamination specialists should

indicate how rejections may be overcome and how problems may be resolved. Where a

rejection not based on prior art is proper (lack of adequate written description,

enablement, or utility, etc.) such rejection should be stated with a full development of

the reasons rather than by a mere conclusion. A failure to follow this approach can lead

to unnecessary delays in the prosecution of the application.

The examination of reissue applications is covered in

MPEP Chapter

1400

, reexamination proceedings are covered in

MPEP Chapters

2200

(

ex parte

) and

2600

(

inter

partes

), and supplemental examination is covered in

MPEP Chapter

2800

.

Prior to focusing on specific statutory requirements,

examiners must begin examination by determining what, precisely, the inventor or joint

inventor has invented and is seeking to patent, and how the claims relate to and define

that invention. Examiners will review the complete specification, including the detailed

description of the invention, any specific embodiments that have been disclosed, the

claims and any specific, substantial, and credible utilities that have been asserted for

the invention

t, precisely, the inventor or joint

inventor has invented and is seeking to patent, and how the claims relate to and define

that invention. Examiners will review the complete specification, including the detailed

description of the invention, any specific embodiments that have been disclosed, the

claims and any specific, substantial, and credible utilities that have been asserted for

the invention.

After obtaining an understanding of the invention, the

examiner will conduct a search of the prior art and determine whether the invention as

claimed complies with all statutory requirements.

A.

Identify and Understand Any Utility for the Invention

The claimed invention as a whole must be useful. The

purpose of this requirement is to limit patent protection to inventions that possess

a certain level of “real world” value, as opposed to subject matter that represents

nothing more than an idea or concept, or is simply a starting point for future

investigation or research

(Brenner v. Manson,

383 U.S. 519,

528-36, 148 USPQ 689, 693-96 (1966);

In re Fisher,

421 F.3d 1365,

76 USPQ2d 1225 (Fed. Cir. 2005);

In re Ziegler,

992 F.2d 1197,

1200-03, 26 USPQ2d 1600, 1603-06 (Fed. Cir. 1993)).

Examiners should review the application to identify any

asserted utility. The applicant or the inventor is in the best position to explain

why an invention is useful. Accordingly, a complete disclosure should contain some

indication of the practical application for the claimed invention, i.e., why the

applicant asserts the claimed invention is useful. Such a statement will usually

explain the purpose of the invention or how the invention may be used (e.g., a

compound is believed to be useful in the treatment of a particular disorder). Note

that the concept of a “practical application” in the evaluation of utility is

different from the concept of whether a judicial exception is integrated into a

“practical application” in the evaluation of subject matter eligibility

usually

explain the purpose of the invention or how the invention may be used (e.g., a

compound is believed to be useful in the treatment of a particular disorder). Note

that the concept of a “practical application” in the evaluation of utility is

different from the concept of whether a judicial exception is integrated into a

“practical application” in the evaluation of subject matter eligibility. Regardless

of the form of statement of utility, it must enable one ordinarily skilled in the art

to understand why the applicant asserts the claimed invention is useful. See

MPEP §

2106

for subject matter eligibility guidelines and

MPEP §

2107

for utility examination guidelines. The application

may describe more than one utility and practical application, but only one is

necessary. Alternatively, an applicant may rely on the contemporaneous art to provide

that the claimed invention has a well-established utility.

B.

Review the Detailed Disclosure and Specific Embodiments of the Invention

To Understand What the Applicant Has Asserted as the Invention

The written description will provide the clearest

explanation of the invention, by exemplifying the invention, explaining how it

relates to the prior art and explaining the relative significance of various features

of the invention. Accordingly, examiners should continue their evaluation by:

(A) determining the function of the invention,

that is, what the invention does when used as disclosed (e.g., the

functionality of a programmed computer); and

(B) determining the features necessary to

accomplish at least one asserted practical application.

Patent applicants can assist the USPTO by preparing

applications that clearly set forth these aspects of an invention.

C.

Review the Claims

The claims define the property rights provided by a

patent, and thus require careful scrutiny

as disclosed (e.g., the

functionality of a programmed computer); and

(B) determining the features necessary to

accomplish at least one asserted practical application.

Patent applicants can assist the USPTO by preparing

applications that clearly set forth these aspects of an invention.

C.

Review the Claims

The claims define the property rights provided by a

patent, and thus require careful scrutiny. The goal of claim analysis is to identify

the boundaries of the protection sought by the applicant and to understand how the

claims relate to and define what the applicant has indicated is the invention.

Examiners must first determine the scope of a claim by thoroughly analyzing the

language of the claim before determining if the claim complies with each statutory

requirement for patentability. See

In re Hiniker Co.,

150 F.3d

1362, 1369, 47 USPQ2d 1523, 1529 (Fed. Cir. 1998) (“[T]he name of the game is the

claim.”).

Examiners should begin claim analysis by identifying

and evaluating each claim limitation. For processes, the claim limitations will

define steps or acts to be performed. For products, the claim limitations will define

discrete physical structures or materials. Product claims are claims that are

directed to either machines, manufactures or compositions of matter.

Examiners should then correlate each claim limitation

to all portions of the disclosure that describe the claim limitation. This is to be

done in all cases, regardless of whether the claimed invention is defined using

means- (or step-) plus- function language. The correlation step will ensure that

examiners correctly interpret each claim limitation in light of the specification.

The subject matter of a properly construed claim is

defined by the terms that limit the scope of the claim when given their broadest

reasonable interpretation. It is this subject matter that must be examined

d invention is defined using

means- (or step-) plus- function language. The correlation step will ensure that

examiners correctly interpret each claim limitation in light of the specification.

The subject matter of a properly construed claim is

defined by the terms that limit the scope of the claim when given their broadest

reasonable interpretation. It is this subject matter that must be examined. As a

general matter, grammar and the plain meaning of terms as understood by one having

ordinary skill in the art used in a claim will dictate whether, and to what extent,

the language limits the claim scope. See

MPEP § 2111.01

for more information

on the plain meaning of claim language. Language that suggests or makes a feature or

step optional but does not require that feature or step does not limit the scope of a

claim under the broadest reasonable claim interpretation. The following types of

claim language may raise a question as to its limiting effect:

(A) statements of intended use or field of use,

including statements of purpose or intended use in the preamble,

(B) “adapted to” or “adapted for” clauses,

(C) "wherein" or "whereby" clauses,

(D) contingent limitations,

(E) printed matter, or

(F) terms with associated functional

language.

This list of examples is not intended to be exhaustive.

The determination of whether particular language is a limitation in a claim depends

on the specific facts of the case. See, e.g.,

Griffin v. Bertina,

285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002)(finding that a “wherein” clause

limited a process claim where the clause gave “meaning and purpose to the

manipulative steps”). For more information about these types of claim language and

how to determine whether they have a limiting effect on claim scope, see

MPEP §§

2111.02

through

2111.05

.

Examiners are to give claims their broadest

reasonable interpretation in light of the supporting disclosure. See

MPEP §

2111

. Disclosure may be express, implicit, or inherent

e gave “meaning and purpose to the

manipulative steps”). For more information about these types of claim language and

how to determine whether they have a limiting effect on claim scope, see

MPEP §§

2111.02

through

2111.05

.

Examiners are to give claims their broadest

reasonable interpretation in light of the supporting disclosure. See

MPEP §

2111

. Disclosure may be express, implicit, or inherent.

Examiners are to give claimed means- (or step-) plus- function limitations their

broadest reasonable interpretation consistent with all corresponding structures (or

materials or acts) described in the specification and their equivalents. See

In re Aoyama,

656 F.3d 1293, 1297, 99 USPQ2d 1936, 1939 (Fed.

Cir. 2011). Further guidance in interpreting the scope of equivalents is provided in

MPEP §§

2181

through

2186

.

While it is appropriate to use the specification to

determine what applicant intends a term to mean, a positive limitation from the

specification cannot be read into a claim that does not itself impose that

limitation. See

MPEP §

2111.01

, subsection II. As explained in

MPEP §

2111

, giving a claim its broadest reasonable interpretation

during prosecution will reduce the possibility that the claim, when issued, will be

interpreted more broadly than is justified.

Finally, when evaluating the scope of a claim, every

limitation in the claim must be considered. Examiners may not dissect a claimed

invention into discrete elements and then evaluate the elements in isolation.

Instead, the claim as a whole must be considered. See, e.g.,

Diamond v.

Diehr,

450 U.S. 175, 188-89, 209 USPQ 1, 9 (1981) (“In determining the

eligibility of respondents’ claimed process for patent protection under

§

101

, their claims must be considered as a whole. It is

inappropriate to dissect the claims into old and new elements and then to ignore the

presence of the old elements in the analysis

stead, the claim as a whole must be considered. See, e.g.,

Diamond v.

Diehr,

450 U.S. 175, 188-89, 209 USPQ 1, 9 (1981) (“In determining the

eligibility of respondents’ claimed process for patent protection under

§

101

, their claims must be considered as a whole. It is

inappropriate to dissect the claims into old and new elements and then to ignore the

presence of the old elements in the analysis. This is particularly true in a process

claim because a new combination of steps in a process may be patentable even though

all the constituents of the combination were well known and in common use before the

combination was made.”).

II.

CONDUCT A THOROUGH SEARCH OF THE PRIOR ART

Prior to evaluating the claimed invention for

patentability, examiners are expected to conduct a thorough search of the prior art. See

MPEP §§

904

through

904.03

for more information about how

to conduct a search. In many cases, the result of such a search will contribute to

examiners' understanding of the invention. Both claimed and unclaimed aspects of the

invention described in the specification should be searched if there is a reasonable

expectation that the unclaimed aspects may be later claimed. A search must take into

account any structure or material described in the specification and its equivalents

which correspond to the claimed means- (or step-) plus- function limitation, in

accordance with

35 U.S.C. 112(f)

and

MPEP §

2181

through

MPEP § 2186

.

III.

DETERMINE WHETHER THE CLAIMED INVENTION COMPLIES WITH 35 U.S.C. 101

A.

Consider the Breadth of 35 U.S.C. 101 Under Controlling Law

Section

101

of title 35, United States Code, provides:

Whoever invents or discovers any new and useful

process, machine, manufacture, or composition of matter, or any new and useful

improvement thereof, may obtain a patent therefor, subject to the conditions and

requirements of this title.

35 U.S.C

INVENTION COMPLIES WITH 35 U.S.C. 101

A.

Consider the Breadth of 35 U.S.C. 101 Under Controlling Law

Section

101

of title 35, United States Code, provides:

Whoever invents or discovers any new and useful

process, machine, manufacture, or composition of matter, or any new and useful

improvement thereof, may obtain a patent therefor, subject to the conditions and

requirements of this title.

35 U.S.C.

101

has been interpreted as imposing four requirements: (i)

only one patent may be obtained for an invention; (ii) the inventor(s) must be

identified in an application filed on or after September 16, 2012 or must be the

applicant in applications filed before September 16, 2012; (iii) the claimed

invention must be eligible for patenting; and (iv) the claimed invention must be

useful (have utility).

See

MPEP §

2104

for a discussion of the four requirements,

MPEP §

2106

for a discussion of eligibility, and

MPEP §

2107

for the utility examination guidelines.

The patent eligibility inquiry under

35 U.S.C. 101

is a threshold inquiry. Even if a claimed invention qualifies as eligible subject

matter under

35

U.S.C. 101

, it must also satisfy the other conditions and

requirements of the patent laws, including the requirements for novelty

(

35 U.S.C.

102

), nonobviousness (

35 U.S.C. 103

), and adequate

description and definite claiming (

35 U.S.C. 112

).

Bilski

v. Kappos,

561 U.S. 593, 602, 95 USPQ2d 1001, 1006 (2010). Therefore,

examiners should avoid focusing on only issues of patent-eligibility under

35 U.S.C.

101

to the detriment of considering an application for

compliance with the requirements of

35 U.S.C. 102

,

35 U.S.C. 103

,

and

35 U.S.C.

112

, and should avoid treating an application solely on the

basis of patent-eligibility under

35 U.S.C. 101

except in the most

extreme cases.

IV.

EVALUATE APPLICATION FOR COMPLIANCE WITH 35 U.S.C. 112

A.

Determine Whether the Claimed Invention Complies with 35 U.S.C. 112(b)

or Pre-AIA 35 U.S.C. 112, Second Paragraph Requirements

35 U.S.C

quirements of

35 U.S.C. 102

,

35 U.S.C. 103

,

and

35 U.S.C.

112

, and should avoid treating an application solely on the

basis of patent-eligibility under

35 U.S.C. 101

except in the most

extreme cases.

IV.

EVALUATE APPLICATION FOR COMPLIANCE WITH 35 U.S.C. 112

A.

Determine Whether the Claimed Invention Complies with 35 U.S.C. 112(b)

or Pre-AIA 35 U.S.C. 112, Second Paragraph Requirements

35 U.S.C.

112(b)

contains two separate and distinct requirements: (A)

that the claim(s) set forth the subject matter the inventor or a joint inventor

regards as the invention, and (B) that the claim(s) particularly point out and

distinctly claim the invention. An application will be deficient under the first

requirement of

35 U.S.C. 112(b)

when evidence

outside the application as filed, e.g., admissions, shows that the inventor or a

joint inventor regards the invention to be different from what is claimed (see

MPEP §

2171

-

MPEP § 2172.01

).

An application fails to comply with the second

requirement of

35 U.S.C. 112(b)

when the claims

do not set out and define the invention with a reasonable degree of precision and

particularity. In this regard, the definiteness of the language must be analyzed, not

in a vacuum, but always in light of the teachings of the disclosure as it would be

interpreted by one of ordinary skill in the art. Applicant’s claims, interpreted in

light of the disclosure, must reasonably apprise a person of ordinary skill in the

art of the invention.

The scope of a limitation that invokes

35

U.S.C. 112(f)

is defined as the corresponding structure or

material set forth in the written description and equivalents thereof that perform

the claimed function. See

MPEP § 2181

through

MPEP §

2186

. See

MPEP § 2173

et seq.

for a discussion of a variety of issues pertaining to the

35

U.S.C. 112(b)

requirement that the claims particularly point

out and distinctly claim the invention.

B.

Determine Whether the Claimed Invention Complies with 35 U.S.C. 112(a)

or 35 U.S.C. 112, First Paragraph Requirements

35 U.S.C

nts thereof that perform

the claimed function. See

MPEP § 2181

through

MPEP §

2186

. See

MPEP § 2173

et seq.

for a discussion of a variety of issues pertaining to the

35

U.S.C. 112(b)

requirement that the claims particularly point

out and distinctly claim the invention.

B.

Determine Whether the Claimed Invention Complies with 35 U.S.C. 112(a)

or 35 U.S.C. 112, First Paragraph Requirements

35 U.S.C.

112(a)

contains three separate and distinct requirements:

(A) adequate written description,

(B) enablement, and

(C) best mode.

1.

Adequate Written Description

For the written description requirement, an

applicant’s specification must reasonably convey to those skilled in the art that

the inventor was in possession of the claimed invention as of the date of

invention. See

MPEP

§ 2163

for further guidance with respect to the

evaluation of a patent application for compliance with the written description

requirement.

2.

Enabling Disclosure

An applicant’s specification must enable a person

skilled in the art to make and use the claimed invention without undue

experimentation. The fact that experimentation is complex, however, will not make

it undue if a person of skill in the art routinely engages in such

experimentation.

See

MPEP § 2164

et seq.

for detailed guidance with regard to the enablement

requirement of

35 U.S.C. 112(a)

.

3.

Best Mode

Determining compliance with the best mode

requirement requires a two-prong inquiry:

(1) at the time the application was filed, did

the inventor possess a best mode for practicing the invention; and

ndue if a person of skill in the art routinely engages in such

experimentation.

See

MPEP § 2164

et seq.

for detailed guidance with regard to the enablement

requirement of

35 U.S.C. 112(a)

.

3.

Best Mode

Determining compliance with the best mode

requirement requires a two-prong inquiry:

(1) at the time the application was filed, did

the inventor possess a best mode for practicing the invention; and

(2) if the inventor did possess a best mode,

does the written description disclose the best mode in such a manner that a

person of ordinary skill in the art could practice the best mode.

See

MPEP § 2165

et seq.

for additional guidance. Deficiencies related to

disclosure of the best mode for carrying out the claimed invention are not usually

encountered during examination of an application because evidence to support such

a deficiency is seldom in the record.

Fonar Corp. v. General Elec.

Co.,

107 F.3d 1543, 1548-49, 41 USPQ2d 1801, 1804-05 (Fed. Cir.

1997).

V.

DETERMINE WHETHER THE CLAIMED INVENTION COMPLIES WITH 35 U.S.C. 102 AND

103

Reviewing a claimed invention for compliance with

35 U.S.C.

102

and

35 U.S.C.103

begins with a

comparison of the claimed subject matter to what is known in the prior art. See

MPEP §§

2131

-

2146

and

MPEP §§

2150

-

2159

for specific guidance on

patentability determinations under

35 U.S.C. 102

and

35 U.S.C. 103

. If

no differences are found between the claimed invention and the prior art, then the

claimed invention lacks novelty and is to be rejected by USPTO personnel under

35 U.S.C.

102

. Once differences are identified between the claimed invention

and the prior art, those differences must be assessed and resolved in light of the

knowledge possessed by a person of ordinary skill in the art. Against this backdrop, one

must determine whether the invention would have been obvious to one of ordinary skill in

the art. If not, the claimed invention satisfies

35 U.S.C. 103

.

VI

.C.

102

. Once differences are identified between the claimed invention

and the prior art, those differences must be assessed and resolved in light of the

knowledge possessed by a person of ordinary skill in the art. Against this backdrop, one

must determine whether the invention would have been obvious to one of ordinary skill in

the art. If not, the claimed invention satisfies

35 U.S.C. 103

.

VI.

CLEARLY COMMUNICATE FINDINGS, CONCLUSIONS AND THEIR BASES

Once examiners have completed the above analyses of the

claimed invention under all the statutory provisions, including

35 U.S.C. 101

,

35 U.S.C.

112

,

35 U.S.C. 102

, and

35 U.S.C. 103

,

they should review all the proposed rejections and their bases to confirm that a

prima facie

case of unpatentability exists. Only then should any

rejection be imposed in an Office action. The Office action should clearly communicate

the findings, conclusions and reasons which support them.

EXAMINERS SHOULD USE THE APPLICABLE FORM PARAGRAPHS IN

OFFICE ACTIONS TO STATE THE BASIS FOR ANY OBJECTIONS OR REJECTIONS TO REDUCE THE CHANCE

OF A MISUNDERSTANDING AS TO THE GROUNDS OF OBJECTION OR REJECTION.

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