Editing MPEP 2107

<noinclude>{{MPEP Section|2106|2100|2111}}</noinclude>

==[[MPEP 2107|2107 Guidelines for Examination of Applications for Compliance with the Utility Requirement]]==

<noinclude><div class="noautonum">__TOC__</div></noinclude>

EXAMINATION GUIDELINES FOR THE 
UTILITY REQUIREMENT

Office personnel are to adhere to the following 
procedures when reviewing patent applications for 
compliance with the “useful invention” (“utility”) 
requirement of 35 U.S.C. 101 and 112, first paragraph. 

'''(A) Read the claims and the supporting written  description:'''  

When reading the claims and the written disclosure the examiner is required to consider the following-:

(1) Determine what the applicant has claimed, 
noting any specific embodiments of the invention.

(2) Ensure that the claims define statutory subject
matter (i.e., a process, machine, manufacture, 
composition of matter, or improvement thereof).

(3) If at any time during the examination, it 
becomes readily apparent that the claimed invention 
has a well-established utility, do not impose a rejection 
based on lack of utility. 

'''Criteria for a well-established utility:''' 

(i) Immediate appreciation by a person of ordinary skill in 
the art on the usefulness of the invention based on the  
characteristics of the invention 
(e.g., properties or applications of a product or 
process), and 

(ii) Presence of specific, substantial and credible utility.


'''(B) Determine if the applicant has asserted for the claimed invention any specific and substantial 
utility that is credible:'''

An assertion of the usefulness of the claimed invention which is 
considered credible by a person of ordinary skill, eliminates the imposition of
rejection based on lack of utility. 

Credibility is assessed from the perspective 
of one of ordinary skill in the art in view of the 
disclosure and any other evidence of record (e.g., test 
data, affidavits or declarations from experts in the art, 
patents or printed publications) that is probative of 
the applicant’s assertions. An applicant need only provide 
one credible assertion of specific and substantial 
utility for each claimed invention to satisfy the utility 
requirement.

A claimed invention must have a specific 
and substantial utility. This requirement excludes 
“throw-away,” “insubstantial,” or “nonspecific” utilities, 
such as the use of a complex invention as landfill, 
as a way of satisfying the utility requirement of 
35 U.S.C. 101.


If no assertion of specific and substantial 
utility for the claimed invention made by the applicant 
is credible, and the claimed invention does not have a 
readily apparent well-established utility, reject the 
claim(s) under 35 U.S.C. 101 on the grounds that the 
invention as claimed lacks utility. 

Also reject the claims under 35 U.S.C. 112, first paragraph, on the 
basis that the disclosure fails to teach how to use the 
invention as claimed. The 35 U.S.C. 112, first paragraph, 
rejection imposed in conjunction with a 
35 U.S.C. 101 rejection should incorporate by reference 
the grounds of the corresponding 35 U.S.C. 101 rejection.

Further, if the applicant has not asserted any specific 
and substantial utility for the claimed invention 
and it does not have a readily apparent well-established 
utility, impose a rejection under 35 U.S.C. 101, 
emphasizing that the applicant has not disclosed a 
specific and substantial utility for the invention. Also 
impose a separate rejection under 35 U.S.C. 112, first 
paragraph, on the basis that the applicant has not disclosed 
how to use the invention due to the lack of a 
specific and substantial utility. 


The 35 U.S.C. 101 and 
112 rejections shift the burden of coming forward 
with evidence to the applicant to:

(i)Explicitly identify a specific and substantial 
utility for the claimed invention; and

(ii)Provide evidence that one of ordinary 
skill in the art would have recognized that the identified 
specific and substantial utility was well-established 
at the time of filing. 

The examiner should 
review any subsequently submitted evidence of utility 
using the criteria outlined above. The examiner 
should also ensure that there is an adequate nexus 
between the evidence and the properties of the now 
claimed subject matter as disclosed in the application 
as filed. That is, the applicant has the burden to establish 
a probative relation between the submitted evidence 
and the originally disclosed properties of the 
claimed invention.

'''(C) Any rejection based on lack of utility should include a detailed explanation why the claimed invention has no specific and substantial credible utility.''' 


Whenever possible, the examiner should provide documentary evidence regardless of publication date (e.g., scientific or technical journals, excerpts from 
treatises or books, or U.S. or foreign patents) to support the factual basis for the prima facie showing of no specific and substantial credible utility. If documentary 
evidence is not available, the examiner should specifically explain the scientific basis for his or her factual conclusions.

'''(1)Where the asserted utility is not specific
or substantial:'''

a prima facie showing must establish 
that it is more likely than not that a person of ordinary 
skill in the art would not consider that any utility 
asserted by the applicant would be specific and substantial. 

The prima facie showing must contain the 
following elements:

(i)An explanation that clearly sets forth 
the reasoning used in concluding that the asserted utility 
for the claimed invention is not both specific and 
substantial nor well-established;

(ii)Support for factual findings relied 
upon in reaching this conclusion; and

(iii)An evaluation of all relevant evidence 
of record, including utilities taught in the closest prior 
art.

'''(2)Where the asserted specific and substantial 
utility is not credible:'''

a prima facie showing of no 
specific and substantial credible utility must establish 
that it is more likely than not that a person skilled in 
the art would not consider credible any specific and 
substantial utility asserted by the applicant for the 
claimed invention. 

The prima facie showing must 
contain the following elements:

(i)An explanation that clearly sets forth 
the reasoning used in concluding that the asserted specific 
and substantial utility is not credible;

(ii)Support for factual findings relied 
upon in reaching this conclusion; and

(iii)An evaluation of all relevant evidence 
of record, including utilities taught in the closest prior 
art.

'''(3)Where no specific and substantial utility 
is disclosed or is well-established:'''

a prima facie 
showing of no specific and substantial utility need 
only establish that applicant has not asserted a utility 
and that, on the record before the examiner, there is no 
known well-established utility.


'''(D)A rejection based on lack of utility should not be maintained if an asserted utility for the claimed 
invention would be considered specific, substantial, and credible by a person of ordinary skill in the art in 
view of all evidence of record.'''

Office personnel are reminded that they must treat 
as true a statement of fact made by an applicant in 
relation to an asserted utility, unless countervailing 
evidence can be provided that shows that one of ordinary 
skill in the art would have a legitimate basis to 
doubt the credibility of such a statement. 

Similarly, Office personnel must accept an opinion from a qualified 
expert that is based upon relevant facts whose 
accuracy is not being questioned; it is improper to disregard 
the opinion solely because of a disagreement 
over the significance or meaning of the facts offered.

Once a prima facie showing of no specific and substantial 
credible utility has been properly established, 
the applicant bears the burden of rebutting it. The 
applicant can do this by amending the claims, by providing 
reasoning or arguments, or by providing evidence 
in the form of a declaration under 37 CFR 
1.132 or a patent or a printed publication that rebuts 
the basis or logic of the prima facie showing.

If the applicant responds to the prima facie rejection, the 
Office personnel should review the original disclosure, 
any evidence relied upon in establishing the 
prima facie showing, any claim amendments, and any 
new reasoning or evidence provided by the applicant 
in support of an asserted specific and substantial credible 
utility. It is essential for Office personnel to recognize, 
fully consider and respond to each substantive 
element of any response to a rejection based on lack 
of utility. Only where the totality of the record continues 
to show that the asserted utility is not specific, 
substantial, and credible should a rejection based on 
lack of utility be maintained.

If the applicant satisfactorily rebuts a prima facie rejection based on lack of utility under 35 U.S.C. 101, 
withdraw the 35 U.S.C. 101 rejection and the corresponding 
rejection imposed under 35 U.S.C. 112, first 
paragraph.

===2107.01 General Principles Governing Utility Rejections [R-5]===


{{Statute|35 U.S.C. 101 Inventions patentable.}}
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. 
|}


'''As interpreted by the  Federal courts, 35 U.S.C. 101 has two purposes.''' 

1- First,  35 U.S.C. 101 defines which categories of inventions 
are eligible for patent protection. An invention that is 
not a machine, an article of manufacture, a composition 
or a process cannot be patented. 
 
2- Second, 35 U.S.C. 101 serves to ensure that patents 
are granted on only those inventions that are “useful.” 


'''Deficiencies under the “useful invention” requirement  of 35 U.S.C. 101 will arise in one of two forms.''' 

'''1- Where it is not apparent why the invention is “useful.”''' 

This can occur when an applicant fails to 
identify any specific and substantial utility for the 
invention or fails to disclose enough information 
about the invention to make its usefulness immediately 
apparent to those familiar with the technological 
field of the invention. 

'''2- Where an assertion of specific and substantial utility for the invention made by an applicant is not credible.'''


'''I.SPECIFIC AND SUBSTANTIAL REQUIREMENTS'''

To satisfy 35 U.S.C. 101, an invention must be 
“useful.” Courts have recognized that the term “useful” 
used with reference to the utility requirement can 
be a difficult term  to define. 

Where an applicant has set forth a specific and substantial 
utility, courts have been reluctant to uphold a rejection 
under 35 U.S.C. 101 solely on the basis that the applicant’s 
opinion as to the nature of the specific and substantial 
utility was inaccurate. 

For example, in Nelsonv. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 
1980), the court reversed a finding by the Office that 
the applicant had not set forth a “practical” utility 
under 35 U.S.C. 101. In this case the applicant 
asserted that the composition was “useful” in a particular 
pharmaceutical application and provided evidence 
to support that assertion. 

Courts have used the labels “practical utility,” “substantial utility,” or “specific 
utility” to refer to this aspect of the “useful 
invention” requirement of 35 U.S.C. 101. 


The Court of Customs and Patent Appeals has stated:

Practical utility is a shorthand way of attributing “real-
world” value to claimed subject matter. In other words, 
one skilled in the art can use a claimed discovery in a 
manner which provides some immediate benefit to the 
public.

Practical considerations require the Office to rely 
on the inventor’s understanding of his or her invention 
in determining whether and in what regard an invention 
is believed to be “useful.” Because of this, Office 
personnel should focus on and be receptive to assertions 
made by the applicant that an invention is “useful” 
for a particular reason. 

A.Specific Utility

A “specific utility” is specific to the subject matter 
claimed and can “provide a well-defined and particular 
benefit to the public. 

This contrasts with a general utility that 
would be applicable to the broad class of the invention. 
Office personnel should distinguish between situations 
where an applicant has disclosed a specific 
use for or application of the invention and situations 
where the applicant merely indicates that the invention 
may prove useful without identifying with specificity 
why it is considered useful.

For example, indicating that a compound may be useful in treating 
unspecified disorders, or that the compound has “useful 
biological” properties, would not be sufficient to 
define a specific utility for the compound. 

Similarly, a claim to a polynucleotide whose 
use is disclosed simply as a “gene probe” or “chromosome 
marker” would not be considered to be specific 
in the absence of a disclosure of a specific DNA target. 

A general statement of diagnostic utility, 
such as diagnosing an unspecified disease, would 
ordinarily be insufficient absent a disclosure of what 
condition can be diagnosed. Contrast the situation 
where an applicant discloses a specific biological 
activity and reasonably correlates that activity to a 
disease condition. Assertions falling within the latter 
category are sufficient to identify a specific utility for 
the invention. Assertions that fall in the former category 
are insufficient to define a specific utility for the 
invention, especially if the assertion takes the form of 
a general statement that makes it clear that a “useful” 
invention may arise from what has been disclosed by 
the applicant. 

B.Substantial Utility

An application must show that an invention is 
useful to the public as disclosed in its current form, 
not that it may prove useful at some future date after 
further research. Simply put, to satisfy the ‘substantial’ 
utility requirement, an asserted use must show 
that the claimed invention has a significant and presently 
available benefit to the public.” 

Fisher, 421 F.3d at 1371, 76 USPQ2d at 1230. The claims at issue in 
Fisher were directed to expressed sequence tags 
(ESTs), which are short nucleotide sequences that can 
be used to discover what genes and downstream proteins 
are expressed in a cell. 

The court held that “the claimed ESTs can be used only to gain further information 
about the underlying genes and the proteins encoded for by those genes. 
The claimed ESTs themselves 
are not an end of applicant’s research effort, 
but only tools to be used along the way in the search 
for a practical utility…. 

Applicant does not identify 
the function for the underlying protein-encoding 
genes. Absent such identification, we hold that the 
claimed ESTs have not been researched and understood 
to the point of providing an immediate, well-
defined, real world benefit to the public meriting the 
grant of a patent.” 

Thus a “substantial utility” defines a “real 
world” use. Utilities that require or constitute carrying 
out further research to identify or reasonably confirm 
a “real world” context of use are not substantial utilities. 

For example, both a therapeutic method of treating 
a known or newly discovered disease and an assay 
method for identifying compounds that themselves 
have a “substantial utility” define a “real world” context 
of use. An assay that measures the presence of a 
material which has a stated correlation to a predisposition 
to the onset of a particular disease condition 
would also define a “real world” context of use in 
identifying potential candidates for preventive measures 
or further monitoring. 

On the other hand, the following are examples of situations that require or 
constitute carrying out further research to identify or 
reasonably confirm a “real world” context of use and, 
therefore, do not define “substantial utilities”:

(A)Basic research such as studying the properties 
of the claimed product itself or the mechanisms in 
which the material is involved;

(B)A method of treating an unspecified disease 
or condition;

(C)A method of assaying for or identifying a 
material that itself has no specific and/or substantial 
utility;

(D)A method of making a material that itself has 
no specific, substantial, and credible utility; and

(E)A claim to an intermediate product for use in 
making a final product that has no specific, substantial 
and credible utility. 

Office personnel must be careful not to interpret the 
phrase “immediate benefit to the public” or similar 
formulations in other cases to mean that products or 
services based on the claimed invention must be “currently 
available” to the public in order to satisfy the 
utility requirement. 
 
Rather, any reasonable use that an applicant 
has identified for the invention that can be viewed 
as providing a public benefit should be accepted as 
sufficient, at least with regard to defining a “substantial” 
utility.

C.Research Tools

Some confusion can result when one attempts to 
label certain types of inventions as not being capable 
of having a specific and substantial utility based on 
the setting in which the invention is to be used. 

One example is inventions to be used in a research or laboratory 
setting. Many research tools such as gas chromatographs, 
screening assays, and nucleotide 
sequencing techniques have a clear, specific and 
unquestionable utility (e.g., they are useful in analyzing 
compounds). 

An assessment that focuses on 
whether an invention is useful only in a research setting 
thus does not address whether the invention is in 
fact “useful” in a patent sense. Instead, Office personnel 
must distinguish between inventions that have a 
specifically identified substantial utility and inventions 
whose asserted utility requires further research 
to identify or reasonably confirm. Labels such as 
“research tool,” “intermediate” or “for research purposes” 
are not helpful in determining if an applicant 
has identified a specific and substantial utility for the 
invention. 

II.WHOLLY INOPERATIVE INVENTIONS; 
“INCREDIBLE” UTILITY

An invention that is “inoperative” (i.e., it does not 
operate to produce the results claimed by the patent 
applicant) is not a “useful” invention in the meaning 
of the patent law.

Wholly inoperative cases are rarest to find. A small degree  of utility is sufficient in an application. The claimed invention must 
only be capable of performing some beneficial function . An invention does not lack utility merely 
because the particular embodiment disclosed in the 
patent lacks perfection or performs crudely. 

A commercially successful product is not required nor is it essential that the invention accomplish all its 
intended functions or operate under all conditions. Partial success is sufficient to demonstrate patentable 
utility.

In short, the defense of non-utility 
cannot be sustained without proof of total incapacity.” 
If an invention is only partially successful in achieving 
a useful result, a rejection of the claimed invention 
as a whole based on a lack of utility is not appropriate. 


Situations where an invention is found to be “inoperative” 
and therefore lacking in utility are rare, and 
rejections maintained solely on this ground by a Federal 
court even rarer. In many of these cases, the utility 
asserted by the applicant was thought to be 
“incredible in the light of the knowledge of the art, or 
factually misleading” when initially considered by the 
Office. 

Other cases suggest that on 
initial evaluation, the Office considered the asserted 
utility to be inconsistent with known scientific principles 
or “speculative at best” as to whether attributes of 
the invention necessary to impart the asserted utility 
were actually present in the invention. 

However cast, the underlying finding by the court in these 
cases was that, based on the factual record of the case, 
it was clear that the invention could not and did not 
work as the inventor claimed it did. 

Indeed, the use of many labels to describe a single problem (e.g., a false 
assertion regarding utility) has led to some of the confusion 
that exists today with regard to a rejection 
based on the “utility” requirement. 

Examples of such 
cases include: 
- an invention asserted to change the 
taste of food using a magnetic field (Fregeau v. Mossinghoff, 
776 F.2d 1034, 227 USPQ 848 (Fed. Cir. 
1985)), 

- a perpetual motion machine (Newman v.
Quigg, 877 F.2d 1575, 11 USPQ2d 1340 (Fed. Cir. 
1989)), a flying machine operating on “flapping or 
flutter function” (In re Houghton, 433 F.2d 820, 
167  USPQ 687 (CCPA 1970)), 

- a “cold fusion” process 
for producing energy (In re Swartz, 232 F.3d 862, 56 USPQ2d 1703, (Fed. Cir. 2000)),

 a method for increasing the energy output of fossil fuels upon combustion 
through exposure to a magnetic field (In re 
Ruskin, 354 F.2d 395, 148 USPQ 221 (CCPA 1966)), 

uncharacterized compositions for curing a wide array 
of cancers (In re Citron, 325 F.2d 248, 139 USPQ 516 
(CCPA 1963)), and 

a method of controlling the aging 
process (In re Eltgroth, 419 F.2d 918, 164 
USPQ 221 
(CCPA 1970)). 

'''III.THERAPEUTIC OR PHARMACOLOGICAL  UTILITY'''

Inventions asserted to have utility in the treatment 
of human or animal disorders are subject to the same 
legal requirements for utility as inventions in any 
other field of technology. 

Pharmacological or therapeutic inventions that provide 
any “immediate benefit to the public” satisfy 
35 U.S.C. 101. 

In order to determine the patentability of pharmacological or therapeutic invention,
the Office Personnel are advised to rely on Nelson and other cases as providing general guidance when evaluating the utility of an invention. 

The Court of Customs and Patent Appeals held in Nelson v. Bowler:

Knowledge of the pharmacological activity of any compound 
is obviously beneficial to the public. It is inherently 
faster and easier to combat illnesses and alleviate symptoms 
when the medical profession is armed with an arsenal 
of chemicals having known pharmacological 
activities. Since it is crucial to provide researchers with an 
incentive to disclose pharmacological activities in as 
many compounds as possible, we conclude that adequate 
proof of any such activity constitutes a showing of practical 
utility.

{{Statute|Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ 881, 883 (CCPA 1980)}}

In Nelson v. Bowler, the court addressed the practical 
utility requirement in the context of an interference 
proceeding. 

Bowler challenged the patentability 
of the invention claimed by Nelson on the basis 
that Nelson had failed to sufficiently and persuasively 
disclose in his application a practical utility for the 
invention. 

Nelson had developed and claimed a class 
of synthetic prostaglandins modeled on naturally 
occurring prostaglandins. Naturally occurring prostaglandins 
are bioactive compounds that, at the time 
of Nelson’s application, had a recognized value in 
pharmacology (e.g., the stimulation of uterine smooth 
muscle which resulted in labor induction or abortion, 
the ability to raise or lower blood pressure, etc.). 

To support the utility he identified in his disclosure, Nelson 
included in his application the results of tests 
demonstrating the bioactivity of his new substituted 
prostaglandins relative to the bioactivity of naturally 
occurring prostaglandins. 

The court concluded that 
Nelson had satisfied the practical utility requirement 
in identifying the synthetic prostaglandins as 
pharmacologically active compounds. In reaching this 
conclusion, the court considered and rejected arguments 
advanced by Bowler that attacked the evidentiary 
basis for Nelson’s assertions that the compounds 
were pharmacologically active.
|}


{{Statute|Reference case where asserted utility was incredible}}

Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980), an invention  claiming protection for pharmaceutical compositions for treating leukemia.
 
The active ingredient in the compositions 
was a structural analog to a known anticancer agent. 
The applicant provided evidence showing that the 
claimed analogs had the same general pharmaceutical 
activity as the known anticancer agents. The court 
reversed the Board’s finding that the asserted pharmaceutical 
utility was “incredible,” pointing to the evidence 
that showed the relevant pharmacological 
activity.
|}


'''Utility of Therapeutic inventions at a very early stage of development'''

Courts have found utility for therapeutic 
inventions despite the fact that an applicant is at a 
very early stage in the development of a pharmaceutical 
product or therapeutic regimen based on a claimed 
pharmacological or bioactive compound or composition. 

A successful vitro testing shall marshal resources and direct the expenditure 
of effort to further in vivo testing of the most potent compounds, 
thereby providing an immediate benefit to the 
public, analogous to the benefit provided by the showing 
of an in vivo utility.


'''Utility judgement by USPTO and the requirements of FDA.'''

The Federal Circuit has reiterated that therapeutic 
utility sufficient under the patent laws is not to be confused 
with the requirements of the FDA with regard to 
safety and efficacy of drugs to marketed in the United 
States.

FDA approval, however, is not a prerequisite for finding a 
compound useful within the meaning of the patent laws. 
Usefulness in patent law, and in particular in the context of pharmaceutical inventions, 
necessarily includes the expectation of further research 
and development. The stage at which an invention in this 
field becomes useful is well before it is ready to be administered 
to humans.

If Phase II testing is considered for 
proving utility, the associated costs would prevent 
many companies from obtaining patent protection on 
promising new inventions, thereby eliminating an incentive 
to pursue, through research and development, potential 
cures in many crucial areas such as the treatment of 
cancer.


These general principles are equally applicable to 
situations where an applicant has claimed a process 
for treating a human or animal disorder. In such cases, 
the asserted utility is usually clear — the invention is 
asserted to be useful in treating the particular disorder. 
If the asserted utility is credible, there is no basis to 
challenge such a claim on the basis that it lacks utility 
under 35 U.S.C. 101.


IV.RELATIONSHIP BETWEEN 35 U.S.C. 112, 
FIRST PARAGRAPH, AND 35 U.S.C. 101

A deficiency under the utility prong of 35 U.S.C. 
101 also creates a deficiency under 35 U.S.C. 112, 
first paragraph. If a claimed invention does not have 
utility, the specification cannot enable one to use it.


Courts have also cast the 
35 U.S.C. 101/35 U.S.C. 112 relationship such that 35 
U.S.C. 112 presupposes compliance with 35 U.S.C. 
101. 

If the application fails as a matter of 
fact to satisfy 35 U.S.C. § 101, then the application 
also fails as a matter of law to enable one of ordinary 
skill in the art to use the invention under 35 U.S.C. § 
112.


As such, a rejection properly imposed 
under 35 U.S.C. 101 for lack of utility should be 
accompanied with a rejection under 35 U.S.C. 112, 
first paragraph. It is equally clear that a rejection 
based on “lack of utility,” whether grounded upon 35 
U.S.C. 101 or 35 U.S.C. 112, first paragraph, rests on 
the same basis (i.e., the asserted utility is not credible). 

To avoid confusion, any lack of utility rejection 
that is imposed on the basis of 35 U.S.C. 101 should be accompanied by a rejection based on 35 
U.S.C. 112, first paragraph. 

The 35 U.S.C. 112, first 
paragraph, rejection should be set out as a separate 
rejection that incorporates by reference the factual 
basis and conclusions set forth in the 35 U.S.C. 101rejection. 

The 35 U.S.C. 112, first paragraph, rejection 
should indicate that because the invention as 
claimed does not have utility, a person skilled in the 
art would not be able to use the invention as claimed, 
and as such, the claim is defective under 35 U.S.C. 
112, first paragraph. 

A 35 U.S.C. 112, first paragraph, 
rejection based on lack of utility should not be 
imposed or maintained unless an appropriate basis 
exists for imposing a utility rejection under 
35 U.S.C. 101. In other words, Office personnel 
should not impose a 35 U.S.C. 112, first paragraph, 
rejection grounded on a “lack of utility” basis unless a 
35 U.S.C. 101 rejection is proper. In particular, the 
factual showing needed to impose a rejection under 
35 U.S.C. 101 must be provided if a rejection under 
35 U.S.C. 112, first paragraph, is to be imposed on 
“lack of utility” grounds.

It is important to recognize that 35 U.S.C. 112, first 
paragraph, addresses matters other than those related 
to the question of whether or not an invention lacks 
utility. 

These matters include :

- whether the claims are 
fully supported by the disclosure  

- whether the applicant has provided an 
enabling disclosure of the claimed subject matter

- whether the applicant has provided an adequate written description of the 
invention and 

- whether the applicant has disclosed the 
best mode of practicing the claimed invention 

The fact that an 
applicant has disclosed a specific utility for an invention 
and provided a credible basis supporting that specific 
utility does not provide a basis for concluding 
that the claims comply with all the requirements of 
35 U.S.C. 112, first paragraph. 

For example, if an 
applicant has claimed a process of treating a certain 
disease condition with a certain compound and provided 
a credible basis for asserting that the compound 
is useful in that regard, but to actually practice the 
invention as claimed a person skilled in the relevant 
art would have to engage in an undue amount of 
experimentation, the claim may be defective under 
35 U.S.C. 112, but not 35 U.S.C. 101. 

To avoid confusion during examination, any rejection under 
35 U.S.C. 112, first paragraph, based on 
grounds 
other than “lack of utility” should be imposed 
separately from any rejection imposed due to “lack of 
utility” under 35 U.S.C. 101 and 35 U.S.C. 112, first 
paragraph.

===2107.02 Procedural Considerations Related to Rejections for Lack of Utility [R-5]===

I.THE CLAIMED INVENTION IS THE FOCUS 
OF THE UTILITY REQUIREMENT

The claimed invention is the focus of the assessment 
of whether an applicant has satisfied the utility 
requirement. Each claim (i.e., each “invention”), 
therefore, must be evaluated on its own merits for 
compliance with all statutory requirements. 

Generally speaking, however, a dependent claim will define an 
invention that has utility if the independent claim 
from which the dependent claim depends is drawn 
to the same statutory class of invention as the dependent 
claim and the independent claim defines an 
invention having utility. 

An exception to this general 
rule is where the utility specified for the invention 
defined in a dependent claim differs from that indicated 
for the invention defined in the independent 
claim from which the dependent claim depends. 
Where an applicant has established utility for a species 
that falls within an identified genus of compounds, 
and presents a generic claim covering the 
genus, as a general matter, that claim should be 
treated as being sufficient under 35 U.S.C. 101. Only 
where it can be established that other species clearly 
encompassed by the claim do not have utility should a 
rejection be imposed on the generic claim. In such 
cases, the applicant should be encouraged to amend 
the generic claim so as to exclude the species that lack 
utility. 

'''Only one credible assertion of specific utility for the claimed invention is required.'''

It is common and sensible for an applicant to identify 
several specific utilities for an invention, particularly 
where the invention is a product (e.g., a machine, 
an article of manufacture or a composition of matter). 
However, regardless of the category of invention that 
is claimed (e.g., product or process), an applicant 
need only make one credible assertion of specific utility 
for the claimed invention to satisfy 35 U.S.C. 101and 35 U.S.C. 112; additional statements of utility, 
even if not “credible,” do not render the claimed 
invention lacking in utility. 

'''Example:''' 

1- '''USPQ 665, 668 (CCPA 1964)''' : 

"Having found 
that the antibiotic is useful for some purpose, it 
becomes unnecessary to decide whether it is in fact 
useful for the other purposes ‘indicated’ in the specification 
as possibly useful.”; 

Statements made by the applicant in the specification 
or incident to prosecution of the application 
before the Office cannot, standing alone, be the basis 
for a lack of utility rejection under 35 U.S.C. 101 or 
35 U.S.C. 112. 


An applicant may include statements 
in the specification whose technical accuracy cannot 
be easily confirmed if those statements are not necessary 
to support the patentability of an invention with 
regard to any statutory basis. Thus, the Office should 
not require an applicant to strike nonessential statements 
relating to utility from a patent disclosure, 
regardless of the technical accuracy of the statement 
or assertion it presents. Office personnel should also 
be especially careful not to read into a claim 
unclaimed results, limitations or embodiments of an 
invention. Doing so can inappropriately change the relationship 
of an asserted utility to the claimed invention 
and raise issues not relevant to examination of that 
claim.


'''II.IS THERE AN ASSERTED OR WELL-ESTABLISHED 
UTILITY FOR THE 
CLAIMED INVENTION?'''

Upon initial examination, the examiner should 
review the specification to determine if there are 
any statements asserting that the claimed invention is 
useful for any particular purpose. A complete disclosure 
should include a statement which identifies a 
specific and substantial utility for the invention. 


'''A.An Asserted Utility Must Be Specific and Substantial'''

A statement of specific and substantial utility 
should fully and clearly explain why the applicant 
believes the invention is useful. Such statements will 
usually explain the purpose of or how the invention 
may be used (e.g., a compound is believed to be useful 
in the treatment of a particular disorder). Regardless 
of the form of statement of utility, it must enable 
one ordinarily skilled in the art to understand why the 
applicant believes the claimed invention is useful. 

Except where an invention has a well-established 
utility, the failure of an applicant to specifically identify 
why an invention is believed to be useful renders 
the claimed invention deficient under 35 U.S.C. 101 and 35 U.S.C. 112, first paragraph. 


In such cases, the applicant has failed to identify a “specific and substantial 
utility” for the claimed invention. For example, 
a statement that a composition has an unspecified 
“biological activity” or that does not explain why a 
composition with that activity is believed to be useful 
fails to set forth a “specific and substantial utility.” 

'''USPQ2d 1600, 1604 (Fed. Cir. 1993):''' 

disclosure that composition is “plastic-like” and can form 
“films” not sufficient to identify specific and substantial 
utility for invention; 

'''In re Kirk, 376 F.2d 936, 153 USPQ 48 (CCPA 1967):'''

indication that compound is 
“biologically active” or has “biological properties” 
insufficient standing alone. 

A disclosure that identifies a particular biological activity of a 
compound and explains how that activity can be utilized 
in a particular therapeutic application of the 
compound does contain an assertion of specific and 
substantial utility for the invention.

Situations where an applicant either fails to indicate 
why an invention is considered useful, or where the 
applicant inaccurately describes the utility should 
rarely arise. 

One reason for this is that applicants are 
required to disclose the best mode known to them of 
practicing the invention at the time they file their 
application. An applicant who omits a description of 
the specific and substantial utility of the invention, or 
who incompletely describes that utility, may encounter 
problems with respect to the best mode requirement 
of 35 U.S.C. 112, first paragraph.

'''B.No Statement of Utility for the Claimed 
Invention in the Specification Does Not Per Se 
Negate Utility'''

Occasionally, an applicant will not explicitly state 
in the specification or otherwise assert a specific and 
substantial utility for the claimed invention. If no 
statements can be found asserting a specific and substantial 
utility for the claimed invention in the specification, 
Office personnel should determine if the 
claimed invention has a well-established utility. 

An invention has a well-established utility if :

(i) a person of ordinary skill in the art would immediately appreciate 
why the invention is useful based on the characteristics 
of the invention (e.g., properties or applications 
of a product or process), and 

(ii) the utility is specific, substantial, and credible.

If an invention has a well- established utility, rejections under 35 U.S.C. 101 and 
35 U.S.C. 112, first paragraph, based on lack of utility 
should not be imposed. 

In re Folkers, 344 F.2d 970, 145 USPQ 390 (CCPA 1965). For example, if an 
application teaches the cloning and characterization of 
the nucleotide sequence of a well-known protein such 
as insulin, and those skilled in the art at the time of filing 
knew that insulin had a well-established use, it 
would be improper to reject the claimed invention as 
lacking utility solely because of the omitted statement 
of specific and substantial utility.

If a person of ordinary skill would not immediately 
recognize a specific and substantial utility for the 
claimed invention (i.e., why it would be useful) based 
on the characteristics of the invention or statements 
made by the applicant, the examiner should reject the 
application under 35 U.S.C. 101 and under 35 U.S.C. 
112, first paragraph, as failing to identify a specific 
and substantial utility for the claimed invention. 

The rejection should clearly indicate that the basis of the 
rejection is that the application fails to identify a specific 
and substantial utility for the invention. The 
rejection should also specify that the applicant must 
reply by indicating why the invention is believed useful 
and where support for any subsequently asserted 
utility can be found in the specification as filed. 

If the applicant subsequently indicates why the 
invention is useful, Office personnel should review 
that assertion according to the standards articulated 
below for review of the credibility of an asserted utility.


'''III.EVALUATING THE CREDIBILITY OF AN 
ASSERTED UTILITY'''

'''A.An Asserted Utility Creates a Presumption of Utility'''

In most cases, an applicant’s assertion of utility creates 
a presumption of utility that will be sufficient to 
satisfy the utility requirement of 35 U.S.C. 101. 

As a matter of Patent Office practice, a specification 
which contains a disclosure of utility which corresponds 
in scope to the subject matter sought to be patented must 
be taken as sufficient to satisfy the utility requirement of § 
101 for the entire claimed subject matter unless there is a 
reason for one skilled in the art to question the objective 
truth of the statement of utility or its scope.

In re Langer, 503 F.2d at 1391, 183 USPQ at 297 
(emphasis in original). The “Langer” test for utility 
has been used by both the Federal Circuit and the 
Court of Customs and Patent Appeals in evaluation of 
rejections under 35 U.S.C. 112, first paragraph, where 
the rejection is based on a deficiency under 35 U.S.C. 
101. In In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 
(Fed. Cir. 1995), the Federal Circuit explicitly 
adopted the Court of Customs and Patent Appeals formulation 
of the “Langer” standard for 35 
U.S.C. 112, 
first paragraph rejections, as it was expressed in a 
slightly reworded format in In re Marzocchi, 439 F.2d 
220, 223, 169 USPQ 367, 369 (CCPA 1971), namely:

A specification disclosure which contains a teaching of 
the manner and process of making and using the invention 
in terms which correspond in scope to those used in 
describing and defining the subject matter sought to be 
patented must be taken as in compliance with the enabling 
requirement of the first paragraph of § 112 unless there is 
reason to doubt the objective truth of the statements contained 
therein which must be relied on for enabling support. 


Thus, Langer and subsequent cases direct the 
Office to presume that a statement of utility made by 
an applicant is true.  

For obvious reasons of efficiency and in deference 
to an applicant’s understanding of his or her 
invention, when a statement of utility is evaluated, 
Office personnel should not begin by questioning the 
truth of the statement of utility. Instead, any inquiry 
must start by asking if there is any reason to question 
the truth of the statement of utility. This can be done 
by simply evaluating the logic of the statements made, 
taking into consideration any evidence cited by the 
applicant. If the asserted utility is credible (i.e., 
believable based on the record or the nature of the 
invention), a rejection based on “lack of utility” is not 
appropriate. Clearly, Office personnel should not 
begin an evaluation of utility by assuming that an 
asserted utility is likely to be false, based on the technical 
field of the invention or for other general reasons.


Compliance with 35 U.S.C. 101 is a question of 
fact. Thus, to overcome the presumption 
of truth that an assertion of utility by the applicant 
enjoys, Office personnel must establish that it is 
more 
likely than not that one of ordinary skill in the 
art would doubt (i.e., “question”) the truth of the statement 
of utility. The evidentiary standard to be used 
throughout ex parte examination in setting forth a 
rejection is a preponderance of the totality of the evidence 
under consideration. In re Oetiker, 977 F.2d 
1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) 
(“After evidence or argument is submitted by the 
applicant in response, patentability is determined 
on 
the totality of the record, by a preponderance of 
evidence with due consideration to persuasiveness of 
argument.”); In re Corkill, 771 F.2d 1496, 




 

1500,
 
226 
USPQ 1005, 1008 (Fed. Cir. 1985). A preponderance 
of the evidence exists when it suggests 
that it is more likely than not that the assertion in 
question is true. Herman v. Huddleston, 459 U.S. 375, 
390 (1983). To do this, Office personnel must provide 
evidence sufficient to show that the statement of 
asserted utility would be considered “false” by a person 
of ordinary skill in the art. Of course, a person of 
ordinary skill must have the benefit of both facts and 
reasoning in order to assess the truth of a statement. 
This means that if the applicant has presented facts 
that support the reasoning used in asserting a utility, 
Office personnel must present countervailing facts 
and reasoning sufficient to establish that a person of 
ordinary skill would not believe the applicant’s assertion 
of utility. In re Brana, 51 F.3d 1560, 34 USPQ2d 
1436 (Fed. Cir. 1995). The initial evidentiary standard 
used during evaluation of this question is a preponderance 
of the evidence (i.e., the totality of facts and reasoning 
suggest that it is more likely than not that the 
statement of the applicant is false). 

B.When Is an Asserted Utility Not Credible?

Where an applicant has specifically asserted that an 
invention has a particular utility, that assertion cannot 
simply be dismissed by Office personnel as being 
“wrong,” even when there may be reason to believe 
that the assertion is not entirely accurate. Rather, 
Office personnel must determine if the assertion of 
utility is credible (i.e., whether the assertion of utility 
is believable to a person of ordinary skill in the art 
based on the totality of evidence and reasoning provided). 
An assertion is credible unless (A) the logic 
underlying the assertion is seriously flawed, or (B) the 
facts upon which the assertion is based are inconsistent 
with the logic underlying the assertion. Credibility 
as used in this context refers to the reliability of the 
statement based on the logic and facts that are offered 
by the applicant to support the assertion of utility.

One situation where an assertion of utility would 
not be considered credible is where a person of ordinary 
skill would consider the assertion to be “incredible 
in view of contemporary knowledge” and where 
nothing offered by the applicant would counter what 
contemporary knowledge might otherwise suggest. 
Office personnel should be careful, however, not to 
label certain types of inventions as “incredible” or 
“speculative” as such labels do not provide the correct 
focus for the evaluation of an assertion of utility. 
“Incredible utility” is a conclusion, not a starting point 
for analysis under 35 U.S.C. 101. A conclusion that 
an asserted utility is incredible can be reached only 
after the Office has evaluated both the assertion of the 
applicant regarding utility and any evidentiary basis 
of that assertion. The Office should be particularly 
careful not to start with a presumption that an asserted 
utility is, per se, “incredible” and then proceed to base 
a rejection under 35 U.S.C. 101 on that presumption.

Rejections under 35 U.S.C. 101 based on a lack of 
credible utility have been  sustained by federal 
courts when, for example, the applicant failed to 
disclose any utility for the invention or asserted a utility 
that could only be true if it violated a scientific 
principle, such as the second law of thermodynamics, 
or a law of nature, or was wholly inconsistent with 
contemporary knowledge in the art. In re Gazave, 379 
F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967). Special 
care  should be taken when assessing the credibility 
of an asserted therapeutic utility for a claimed 
invention. In such cases, a previous lack of success in 
treating a disease or condition, or the absence of a 
proven animal model for testing the effectiveness of 
drugs for treating a disorder in humans, should not, 
standing alone, serve as a basis for challenging the 
asserted utility under 35 U.S.C. 101. 


IV.INITIAL BURDEN IS ON THE OFFICE 
TO ESTABLISH A PRIMA FACIE CASE 
AND PROVIDE EVIDENTIARY SUPPORT 
THEREOF

To properly reject a claimed invention under 
35 
U.S.C. 101, the Office must (A) make a prima 
facie showing that the claimed invention lacks utility, 
and (B) provide a sufficient evidentiary basis for factual 
assumptions relied upon in establishing the prima 
facie showing. In re Gaubert, 524 F.2d 1222, 1224, 
187 USPQ 664, 666 (CCPA 1975) (“Accordingly, the 
PTO must do more than merely question operability - 
it must set forth factual reasons which would lead one 
skilled in the art to question the objective truth of the 
statement of operability.”). If the Office 
cannot 
develop a proper prima facie case and provide 
evidentiary support for a rejection under 35 U.S.C. 
101, a rejection on this ground should not be imposed. 




 

See, e.g., In re Oetiker, 977 F.2d 1443, 1445, 
24 
USPQ2d 1443, 1444 (Fed. Cir. 1992) (“[T]he 
examiner bears the initial burden, on review of the 
prior art or on any other ground, of presenting a prima 
facie case of unpatentability. If that burden is met, the 
burden of coming forward with evidence or argument 
shifts to the applicant.... If examination at the initial 
stage does not produce a prima facie case of unpatentability, 
then without more the applicant is entitled to 
grant of the patent.”). See also Fregeau v. Mossinghoff, 
776 F.2d 1034, 227 USPQ 848 (Fed. Cir. 1985) 
(applying prima facie case law to 35 
U.S.C. 101); 
In 
re Piasecki, 745 F.2d 1468, 223 USPQ 785 (Fed. 
Cir. 1984). 

The prima facie showing must be set forth in a 
well-reasoned statement. Any rejection based on lack 
of utility should include a detailed explanation why 
the claimed invention has no specific and substantial 
credible utility. Whenever possible, the examiner 
should provide documentary evidence regardless of 
publication date (e.g., scientific or technical journals, 
excerpts from treatises or books, or U.S. or foreign 
patents) to support the factual basis for the prima 
facie showing of no specific and substantial credible 
utility. If documentary evidence is not available, the 
examiner should specifically explain the scientific 
basis for his or her factual conclusions.

 Where the asserted utility is not specific or substantial, 
a prima facie showing must establish that it is 
more likely than not that a person of ordinary skill in 
the art would not consider that any utility asserted by 
the applicant would be specific and substantial. The 
prima facie showing must contain the following elements:


(A)An explanation that clearly sets forth the reasoning 
used in concluding that the asserted utility for 
the claimed invention is neither both specific and substantial 
nor well-established;

(B)Support for factual findings relied upon in 
reaching this conclusion; and

(C)An evaluation of all relevant evidence of 
record, including utilities taught in the closest prior 
art.

Where the asserted specific and substantial utility is 
not credible, a prima facie showing of no specific and 
substantial credible utility must establish that it is 
more likely than not that a person skilled in the art 
would not consider credible any specific and substantial 
utility asserted by the applicant for the claimed 
invention. The prima facie showing must contain the 
following elements:

(A)An explanation that clearly sets forth the reasoning 
used in concluding that the asserted specific 
and substantial utility is not credible;

(B)Support for factual findings relied upon in 
reaching this conclusion; and

(C)An evaluation of all relevant evidence of 
record, including utilities taught in the closest prior 
art.

Where no specific and substantial utility is disclosed 
or is well-established, a prima facie showing of 
no specific and substantial utility need only establish 
that applicant has not asserted a utility and that, on the 
record before the examiner, there is no known well-
established utility.

It is imperative that Office personnel use specificity 
in setting forth and initial rejection under 35 U.S.C. 
101 and support any factual conclusions made in the 
prima facie showing. 

By using specificity, the applicant will be able to 
identify the assumptions made by the Office in setting 
forth the rejection and will be able to address those 
assumptions properly.

V.EVIDENTIARY REQUESTS BY AN EXAMINER 
TO SUPPORT AN ASSERTED 
UTILITY

In appropriate situations the Office may require an 
applicant to substantiate an asserted utility for a 
claimed invention. See In re Pottier, 376 F.2d 328, 
330, 153 USPQ 407, 408 (CCPA 1967) (“When the 
operativeness of any process would be deemed 
unlikely by one of ordinary skill in the art, it is not 
improper for the examiner to call for evidence of 
operativeness.”). See also In re Jolles, 628 F.2d 1322, 
1327, 206 USPQ 885, 890 (CCPA 1980); In re Citron, 
325 F.2d 248, 139 USPQ 516 (CCPA 1963); In re 
Novak, 306 F.2d 924, 928, 134 USPQ 335, 337 
(CCPA1962). In In re Citron, the court held that when 
an “alleged utility appears to be incredible in the light 
of the knowledge of the art, or factually misleading, 
applicant must establish the asserted utility by acceptable 
proof.” 325 F.2d at 253, 139 USPQ at 520. The 
court approved of the board’s decision which affirmed 




 

the rejection under 35 U.S.C. 101 “in view of the art knowledge of the lack of a cure for cancer and the 
absence of any clinical data to substantiate the allegation.” 
325 F.2d at 252, 139 USPQ at 519 (emphasis in 
original). The court thus established a higher burden 
on the applicant where the statement of use is incredible 
or misleading. In such a case, the examiner should 
challenge the use and require sufficient evidence of 
operativeness. The purpose of this authority is to 
enable an applicant to cure an otherwise defective factual 
basis for the operability of an invention. Because 
this is a curative authority (e.g., evidence is requested 
to enable an applicant to support an assertion that is 
inconsistent with the facts of record in the application), 
Office personnel should indicate not only why 
the factual record is defective in relation to the assertions 
of the applicant, but also, where appropriate, 
what type of evidentiary showing can be provided by 
the applicant to remedy the problem.

Requests for additional evidence should be 
imposed rarely, and only if necessary to support the 
scientific credibility of the asserted utility (e.g., if the 
asserted utility is not consistent with the evidence of 
record and current scientific knowledge). As the Federal 
Circuit recently noted, “[o]nly after the PTO provides 
evidence showing that one of ordinary skill in 
the art would reasonably doubt the asserted utility 
does the burden shift to the applicant to provide rebuttal 
evidence sufficient to convince such a person of 
the invention’s asserted utility.” In re Brana, 51 F.3d 
1560, 34 USPQ2d 1436 (Fed. Cir. 1995) (citing In re 
Bundy, 642 F.2d 430, 433, 209 USPQ 48, 51 (CCPA 
1981)). In Brana,
 
the court pointed out that the purpose 
of treating 
cancer 
with chemical compounds 
does not suggest,
 
per 
se,
 
an 
incredible utility. Where 
the prior art 
disclosed 
“structurally similar compounds 
to those claimed 
by applicants which have 
been proven in vivo to be effective as chemotherapeutic 
agents against various tumor models . . ., one 
skilled in the art would be without basis to reasonably 
doubt applicants’ asserted utility on its face.” 51 F.3d 
at 1566, 34 USPQ2d at 1441. As courts have stated, 
“it is clearly improper for the examiner to make a 
demand for further test data, which as evidence would 
be essentially redundant and would seem to serve for 
nothing except perhaps to unduly burden the applicant.” 
In re Isaacs, 347 F.2d 887, 890, 146 USPQ 193, 
196 (CCPA 1965).

VI.CONSIDERATION OF A REPLY TO A 
PRIMA FACIE REJECTION FOR LACK 
OF UTILITY

If a rejection under 35 U.S.C. 101 has been properly 
imposed, along with a corresponding rejection 
under 35 U.S.C. 112, first paragraph, the burden shifts 
to the applicant to rebut the prima facie showing. In re 
Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 
(Fed. Cir. 1992) (“The examiner bears the initial burden, 
on review of the prior art or on any other ground, 
of presenting a prima facie case of unpatentability. If 
that burden is met, the burden of coming forward with 
evidence or argument shifts to the applicant. . . After 
evidence or argument is submitted by the applicant in 
response, patentability is determined on the totality of 
the record, by a preponderance of evidence with due 
consideration to persuasiveness of argument.”). An 
applicant can do this using any combination of the 
following: amendments to the claims, arguments or 
reasoning, or new evidence submitted in an affidavit 
or declaration under 37 CFR 1.132, or in a printed 
publication. New evidence provided by an applicant 
must be relevant to the issues raised in the rejection. 
For example, declarations in which conclusions are 
set forth without establishing a nexus between those 
conclusions and the supporting evidence, or which 
merely express opinions, may be of limited probative 
value with regard to rebutting a prima facie case. In re 
Grunwell, 609 F.2d 486, 203 USPQ 1055 (CCPA 
1979); In re Buchner, 929 F.2d 660, 18 USPQ2d 1331 
(Fed. Cir. 1991). See MPEP § 716.01(a) through 
§
 
716.01(c).

If the applicant responds to the prima facie rejection, 
Office personnel should review the original disclosure, 
any evidence relied upon in establishing the 
prima facie showing, any claim amendments, and any 
new reasoning or evidence provided by the applicant 
in support of an asserted specific and substantial credible 
utility. It is essential for Office personnel to recognize, 
fully consider and respond to each substantive 
element of any response to a rejection based on lack 
of utility. Only where the totality of the record continues 
to show that the asserted utility is not specific, 
substantial, and credible should a rejection based on 
lack of utility be maintained. If the record as a whole 
would make it more likely than not that the asserted 
utility for the claimed invention would be considered 
credible by a person of ordinary skill in the art, the 




 

Office cannot maintain the rejection. In re Rinehart, 
531 F.2d 1048, 1052, 189 USPQ 143, 147 (CCPA 
1976).

VII.EVALUATION OF EVIDENCE RELATED 
TO UTILITY

There is no predetermined amount or character of 
evidence that must be provided by an applicant to 
support an asserted utility, therapeutic or otherwise. 
Rather, the character and amount of evidence needed 
to support an asserted utility will vary depending on 
what is claimed (Ex parte Ferguson, 117 USPQ 229 
(Bd. App. 1957)), and whether the asserted utility 
appears to contravene established scientific principles 
and beliefs. In re Gazave, 379 F.2d 973, 978, 
154 
USPQ 92, 96 (CCPA 1967); In re Chilowsky, 
229 
F.2d 457, 462, 108 USPQ 321, 325 (CCPA 1956). 
Furthermore, the applicant does not have to provide 
evidence sufficient to establish that an asserted utility 
is true “beyond a reasonable doubt.” In re Irons,
340 
F.2d 974, 978, 144 USPQ 351, 354 (CCPA 1965). 
Nor must an applicant provide evidence such that it 
establishes an asserted utility as a matter of statistical 
certainty. Nelson v. Bowler, 626 F.2d 853, 856-57, 
206 
USPQ 881, 883-84 (CCPA 1980) (reversing the 
Board and rejecting Bowler’s arguments that the evidence 
of utility was statistically insignificant. The 
court pointed out that a rigorous correlation is not 
necessary when the test is reasonably predictive of the 
response). See also Rey-Bellet v. Englehardt, 493 F.2d 
1380, 181 USPQ 453 (CCPA 1974) (data from animal 
testing is relevant to asserted human therapeutic utility 
if there is a “satisfactory correlation between the 
effect on the animal and that ultimately observed in 
human beings”). Instead, evidence will be sufficient 
if, considered as a whole, it leads a person of ordinary 
skill in the art to conclude that the asserted utility is 
more likely than not true.

===2107.03 Special Considerations for Asserted Therapeutic or Pharmacological Utilities===


The Federal courts have consistently reversed 
rejections by the Office asserting a lack of utility for 
inventions claiming a pharmacological or therapeutic 
utility where an applicant has provided evidence that 
reasonably supports such a utility. In view of this, 
Office personnel should be particularly careful in their 
review of evidence provided in support of an asserted 
therapeutic or pharmacological utility.

I.A REASONABLE CORRELATION BETWEEN 
THE EVIDENCE AND THE ASSERTED 
UTILITY IS SUFFICIENT

As a general matter, evidence of pharmacological 
or other biological activity of a compound will be relevant 
to an asserted therapeutic use if there is a reasonable 
correlation between the activity in question 
and the asserted utility. 

An applicant can establish this reasonable correlation by relying 
on 

1- statistically relevant data documenting the 
activity of a compound or composition,

2- arguments or 
reasoning, 

3-documentary evidence (e.g., articles in scientific 
journals), or any combination thereof. 

The applicant does not have to prove that a correlation 
exists between a particular activity and an asserted 
therapeutic use of a compound as a matter of statistical 
certainty, nor does he or she have to provide actual 
evidence of success in treating humans where such a 
utility is asserted. Instead, as the courts have repeatedly 
held, all that is required is a reasonable correlation 
between the activity and the asserted use.


II.STRUCTURAL SIMILARITY TO COMPOUNDS 
WITH ESTABLISHED UTILITY

Courts have routinely found evidence of structural 
similarity to a compound known to have a particular 
therapeutic or pharmacological utility as being supportive 
of an assertion of therapeutic utility for a 
new compound. 

In re Jolles, 628 F.2d 1322, 206 
USPQ 885 (CCPA 1980), the claimed compounds 
were found to have utility based on a finding of 
a close structural relationship to daunorubicin and 
doxorubicin and shared pharmacological activity with 
those compounds, both of which were known to be 
useful in cancer chemotherapy. The evidence of close 
structural similarity with the known compounds 
was presented in conjunction with evidence demonstrating 
substantial activity of the claimed 
compounds in animals customarily employed for 
screening anticancer agents. 

Such evidence should be 
given appropriate weight in determining whether one 
skilled in the art would find the asserted utility credible. 
Office personnel should evaluate not only the 
existence of the structural relationship, but also the 
reasoning used by the applicant or a declarant to 
explain why that structural similarity is believed to be 
relevant to the applicant's assertion of utility.

III.DATA FROM IN VITRO OR ANIMAL 
TESTING IS GENERALLY SUFFICIENT 
TO SUPPORT THERAPEUTIC UTILITY

If reasonably correlated to the particular therapeutic 
or pharmacological utility, data generated using in 
vitro assays, or from testing in an animal model or a 
combination thereof almost invariably will be sufficient 
to establish therapeutic or pharmacological utility 
for a compound, composition or process. 

A  cursory review of cases involving therapeutic inventions 
where 35 U.S.C. 101 was the dispositive issue 
illustrates the fact that the Federal courts are not particularly 
receptive to rejections under 35 U.S.C. 101 based on inoperability. 

Most striking is the fact that in 
those cases where an applicant supplied a reasonable 
evidentiary showing supporting an asserted therapeutic 
utility, almost uniformly the 35 U.S.C. 101-based 
rejection was reversed. 

Only in those cases where the applicant was unable to 
come forward with any relevant evidence to rebut a 
finding by the Office that the claimed invention was 
inoperative was a 35 U.S.C. 101 rejection affirmed by 
the court. 

In re Citron, 325 F.2d 248, 253, 139 USPQ 
516, 520 (CCPA 1963) (therapeutic utility for an 
uncharacterized biological extract not supported or 
scientifically credible); 

In re Buting, 418 F.2d 540, 
543, 163 USPQ 689, 690 (CCPA 1969) (record did 
not establish a credible basis for the assertion that the 
single class of compounds in question would be useful 
in treating disparate types of cancers); 

In re Novak, 
306 F.2d 924, 134 USPQ 335 (CCPA 1962) (claimed 
compounds did not have capacity to effect physiological 
activity upon which utility claim based). 

Contrast, 
however, In re Buting to In re Gardner, 475 F.2d 
1389, 177 USPQ 396 (CCPA 1973), reh'g denied, 
480 F.2d 879 (CCPA 1973), in which the court held 
that utility for a genus was found to be supported 
through a showing of utility for one species. In no 
case has a Federal court required an applicant to support 
an asserted utility with data from human clinical 
trials.

If an applicant provides data, whether from in vitroassays or animal tests or both, to support an asserted 
utility, and an explanation of why that data supports 
the asserted utility, the Office will determine if the 
data and the explanation would be viewed by one 
skilled in the art as being reasonably predictive of the 
asserted utility. 

Office personnel must be careful to evaluate all 
factors that might influence the conclusions of a person 
of ordinary skill in the art as to this question, 
including the test parameters, choice of animal, relationship 
of the activity to the particular disorder to 
be 
treated, characteristics of the compound or composition, 
relative significance of the data provided 
and,
 
most importantly, the explanation offered by 
the 
applicant as to why the information provided 
is 
believed to support the asserted utility. If the data 
supplied is consistent with the asserted utility, the 
Office cannot maintain a rejection under 35 U.S.C. 
101.

Evidence does not have to be in the form of data 
from an art-recognized animal model for the particular 
disease or disease condition to which the asserted 
utility relates. Data from any test that the applicant 
reasonably correlates to the asserted utility should be 
evaluated substantively. Thus, an applicant may provide 
data generated using a particular animal model 
with an appropriate explanation as to why that 
data 
supports the asserted utility. The absence of a 
certification that the test in question is an industry-
accepted model is not dispositive of whether data 
from an animal model is in fact relevant to the 
asserted utility. Thus, if one skilled in the art would 
accept the animal tests as being reasonably predictive

of utility in humans, evidence from those tests should 
be considered sufficient to support the credibility of 
the asserted utility. 

Office personnel should be careful not to find 
evidence unpersuasive simply because no animal 
model for the human disease condition had been 
established prior to the filing of the application. 


IV.HUMAN CLINICAL DATA

Office personnel should not impose on applicants 
the unnecessary burden of providing evidence from 
human clinical trials. There is no decisional law that 
requires an applicant to provide data from human 
clinical trials to establish utility for an invention 
related to treatment of human disorders (see In re 
Isaacs, even with respect to situations where no art-
recognized animal models existed for the human disease 
encompassed by the claims. 

Before a drug can enter human clinical trials, the sponsor, often the applicant, 
must provide a convincing rationale to those especially 
skilled in the art (e.g., the Food and Drug 
Administration) that the investigation may be successful. 
Such a rationale would provide a basis for the 
sponsor’s expectation that the investigation may be 
successful. In order to determine a protocol for phase 
I testing, the first phase of clinical investigation, some 
credible rationale of how the drug might be effective 
or could be effective would be necessary. Thus, as a 
general rule, if an applicant has initiated human clinical 
trials for a therapeutic product or process, Office 
personnel should presume that the applicant has 
established that the subject matter of that trial is reasonably 
predictive of having the asserted therapeutic 
utility. 

V.SAFETY AND EFFICACY CONSIDERA-
TIONS

The Office must confine its review of patent applications 
to the statutory requirements of the patent law. 
Other agencies of the government have been assigned 
the responsibility of ensuring conformance to standards 
established by statute for the advertisement, 
use, sale or distribution of drugs. The FDA pursues a 
two-prong test to provide approval for testing. Under 
that test, a sponsor must show that the investigation 
does not pose an unreasonable and significant risk of 
illness or injury and that there is an acceptable rationale 
for the study. As a review matter, there must be a 
rationale for believing that the compound could be 
effective. If the use reviewed by the FDA is not set 
forth in the specification, FDA review may not satisfy 
35 U.S.C. 101. However, if the reviewed use is one 
set 
forth in the specification, Office personnel must 
be 
extremely hesitant to challenge utility. In such a 
situation, experts at the FDA have assessed the rationale 
for the drug or research study upon which an 
asserted utility is based and found it satisfactory. 
Thus, in challenging utility, Office personnel must be 
able to carry their burden that there is no sound rationale 
for the asserted utility even though experts designated 
by Congress to decide the issue have come to an 
opposite conclusion. “FDA approval, however, is not 
a prerequisite for finding a compound useful within 
the meaning of the patent laws.


 

Thus, while an applicant may on occasion need to 
provide evidence to show that an invention will work 
as claimed, it is improper for Office personnel to 
request evidence of safety in the treatment of humans, 
or regarding the degree of effectiveness. 

VI.TREATMENT OF SPECIFIC DISEASE 
CONDITIONS

Claims directed to a method of treating or curing a 
disease for which there have been no previously successful 
treatments or cures warrant careful review for 
compliance with 35 U.S.C. 101. The credibility of an 
asserted utility for treating a human disorder may be 
more difficult to establish where current scientific 
understanding suggests that such a task would be 
impossible. Such a determination has always required 
a good understanding of the state of the art as of the 
time that the invention was made. For example, prior 
to the 1980’s, there were a number of cases where an 
asserted use in treating cancer in humans was viewed 
as “incredible.”

The fact that there 
is no known cure for a disease, however, cannot serve 
as the basis for a conclusion that such an invention 
lacks utility. Rather, Office personnel must determine 
if the asserted utility for the invention is credible 
based on the information disclosed in the application. 
Only those claims for which an asserted utility is not 
credible should be rejected. In such cases, the Office 
should carefully review what is being claimed by the 
applicant. An assertion that the claimed invention is 
useful in treating a symptom of an incurable disease 
may be considered credible by a person of ordinary 
skill in the art on the basis of a fairly modest amount 
of evidence or support. In contrast, an assertion that 
the claimed invention will be useful in “curing” the 
disease may require a significantly greater amount of 
evidentiary support to be considered credible by a 
person of ordinary skill in the art.

In these cases, it is important to note that the Food 
and Drug Administration has promulgated regulations 
that enable a party to conduct clinical trials for drugs 
used to treat life threatening and severely-debilitating 
illnesses, even where no alternative therapy exists. 

Implicit in these regulations 
is the recognition that experts qualified to 
evaluate the effectiveness of therapeutics can and 
often do find a sufficient basis to conduct clinical trials 
of drugs for incurable or previously untreatable illnesses. 
Thus, affidavit evidence from experts in the 
art indicating that there is a reasonable expectation of 
success, supported by sound reasoning, usually should 
be sufficient to establish that such a utility is credible.