Sanofi-Aventis

Trademark Trial and Appeal Board

Jul 27, 2006

No. 78278816 (T.T.A.B. Jul. 27, 2006)

Mailed:
27 July 2006
AD

UNITED STATES PATENT AND TRADEMARK OFFICE
________

Trademark Trial and Appeal Board
________

In re Sanofi-Aventis
________

Serial No. 78278816
_______

Susan Upton Douglass of Fross Zelnick Lehrman & Zissu, P.C.
for Sanofi-Aventis.

Zhaleh Delaney, Trademark Examining Attorney, Law Office
116 (M.L. Hershkowitz, Managing Attorney).
_______

Before Drost, Zervas, and Cataldo, Administrative Trademark
Judges.

Opinion by Drost, Administrative Trademark Judge:

On July 25, 2003, applicant Sanofi-Aventis, a
corporation of France, applied to register the mark
INCLUSIVE, in typed or standard character form, on the
Principal Register for services ultimately identified as
“clinical research in the filed of hypertension and anti-
hypertensive pharmaceuticals; medical and scientific
THIS DISPOSITION IS
NOT CITABLE AS
PRECEDENT OF THE
TTAB
Ser. No. 78278816
2
research, namely, conducting clinical trials for anti-
hypertensive pharmaceuticals” in Class 42.1
The examining attorney refused to register applicant’s
mark on the ground that the mark, when used in association
with the identified services, is merely descriptive under
Section 2(e)(1) of the Trademark Act, 15 U.S.C.
§ 1052(e)(1). The examining attorney argues (Brief at
unnumbered p. 4, footnote omitted):
The term INCLUSIVE, meaning “comprehensive,” is merely
descriptive in this instance because it immediately
describes a feature of the Applicant’s inclusive
clinical research services that include a diverse
patient group. That is, the Applicant’s clinical
research services are inclusive or comprehensive in
nature because as the Applicant’s specimen and
evidence of record specifically indicates, the
Applicant’s INCLUSIVE trial “was the first to include
a broad range of patient groups, including the
elderly, African-American, and Hispanic/Latino
patients, as well as patients with type 2 diabetes or
the metabolic syndrome.”

The examining attorney maintains that the “evidence of
record showing multiple references to ‘inclusive research’
in a wide variety of fields shows the consumers’ exposure
to and understanding of the term INCLUSIVE in the research
context.” Brief at unnumbered p. 5. The examining
attorney specifically points to applicant’s specimen that

1 Serial No. 78278816 was based on an allegation of a bona fide
intention to use the mark in commerce. Subsequently, the
examining attorney accepted applicant’s second amendment to
allege use. The date of first use and first use in commerce in
that amendment was identified as November 8, 2003.
Ser. No. 78278816
3
“indicates that its INCLUSIVE trial ‘was the first to
include a broad range of patient groups.’” Brief at
unnumbered pp. 6-7. Therefore, the examining attorney
determined that the mark was merely descriptive.
In response, applicant disputes the examining
attorney’s conclusion that its mark is merely descriptive
for its services. It argues (Brief at 5) that the
examining attorney “wrongly equates the meaning of
‘inclusive’ with the meaning of ‘diverse.’” Finally,
applicant maintains (Brief at 7-8) that:
Applicant coined the mark INCLUSIVE as an acronym
based on the full name of a study, IrbesartaN/HCTZ
bLood pressUre reductionS in dIVErse patient
populations… It is common practice in the
pharmaceutical industry for companies to choose marks
for clinical trials that are based on acronyms derived
from words describing the subject matter of the study.
For example, applicant has another study named REACH,
which is an acronym for Reduction of Atherothrombosis
for Continued Health… Consumers for pharmaceutical
clinical trials, including doctors and patients who
participate in the studies are aware of this practice.
Thus, when these consumers see the mark in connection
with the services, they will perceive the name of the
study as a trademark identifying the source of the
study and not as a descriptor of the study.

After the examining attorney made the refusal final,
applicant appealed to this board.
A mark is merely descriptive if it immediately
describes the ingredients, qualities, or characteristics
Ser. No. 78278816
4
of the goods or services or if it conveys information
regarding a function, purpose, or use of the goods or
services. In re Abcor Development Corp., 588 F.2d 811,
200 USPQ 215, 217 (CCPA 1978). See also In re MBNA
America Bank N.A., 340 F.3d 1328, 67 USPQ2d 1778, 1780
(Fed. Cir. 2003) (A “mark is merely descriptive if the
ultimate consumers immediately associate it with a quality
or characteristic of the product or service”); In re Nett
Designs, 236 F.3d 1339, 57 USPQ2d 1564, 1566 (Fed. Cir.
2001).
To be merely descriptive, a term need only describe a
single significant quality or property of the goods or
services. In re Gyulay, 820 F.2d 1216, 3 USPQ2d 1009,
1009 (Fed. Cir. 1987); Meehanite Metal Corp. v.
International Nickel Co., 262 F.2d 806, 120 USPQ 293, 294
(CCPA 1959). See also In re Oppedahl & Larson LLP, 373
F.3d 1171, 71 USPQ2d 1370, 1371 (Fed. Cir. 2004) (“A mark
may be merely descriptive even if it does not describe the
full scope and extent of the applicant’s goods or
services”) (internal quotation marks omitted). We view
the mark in relation to the goods or services, and not in
the abstract, when we consider whether the mark is
descriptive. Abcor, 200 USPQ at 218.
Ser. No. 78278816
5
We now look at the evidence to determine whether the
term INCLUSIVE would be merely descriptive of applicant’s
clinical research services. We start with a definition of
the term that the examining attorney included with her
final Office action:2 “Inclusive” – “taking a great deal
or everything within its scope, comprehensive: an
inclusive survey of world economic affairs.” Next, we
look at applicant’s specimen of use (entitled INCLUSIVE:
Irbesartan/HCTZ Blood Pressure Reductions in Diverse
Patient Populations) (footnotes omitted):
A fixed-dose combination pill containing 2
antihypertesive drugs, an angiotensin receptor
blocker (ARB), and a thiazide-type diruretic (HCTZ)
has been shown to produce significant benefit in
patients whose blood pressure is usually regarded as
more difficult to control. The IrbesartaN/HCTZ bLood
pressure reductionS in dIVErse patient populations
(INCLUSIVE) trial was the first to include a broad
range of patient groups, including elderly, African-
American, and Hispanic/Latino patients, as well as
patients with type 2 diabetes or the metabolic
syndrome. The patients in all of these subgroups all
had a higher rate of blood pressure control than
obtained on monotherapy, and since no effort was made
to intervene in diet or exercise in this study, this
was almost all attributable to the drug therapy, the
INCLUSIVE investigators believe.

INCLUSIVE

The aim of INCLUSIVE, a prospective open-label,
single-arm study, was to determine the efficacy and

2 We have not considered any online dictionaries entries that
were submitted during the appeal stage of this case. In re Total
Quality Group, Inc., 51 USPQ2d 1474, 1476 (TTAB 1999) (We “do not
normally take judicial notice of on-line dictionaries that are
submitted for the first time on appeal”).
Ser. No. 78278816
6
safety of irbesartan/HCTZ 150/12.5 mg and 300/25 mg
fixed combinations in a diverse population of adults
with systolic blood pressure (SBP) uncontrolled on
antihypertensive monotherapy. In addition to the
study’s overall enrollment, investigators also
actively sought to recruit at least 100 patients in
several predefined subgroups who have blood pressure
that is traditionally deemed difficult to control.

Patients

The study started with 1005 patients (mean age 57.2
+/- 11.2 years, 52% women) recruited at 119 sites
throughout the United States. In line with the aim
of the study to recruit patients from subgroups with
hard-to-control blood pressure, they included:

- 46% with the metabolic syndrome (3 or more
criteria according to the National Cholesterol
Education Program [NCEP] definition);

- 30% with type 2 diabetes (defined as fasting
plasma glucose >/= 126 mg/dL and/or on
antidiabetic medication);

- 25% elderly (aged >/= 65 years);

- 23% African American; and

- 14% Hispanic/Latino.

We also look at the evidence (emphasis added in
examples) that the examining attorney has included in
order to establish the descriptiveness of the term
“Inclusive.” Applicant does point out that several of
these articles involve research in the social sciences.
One (www.ccsd.ca) is “Inclusive Social Policy Development:
Ser. No. 78278816
7
Ideas for Practitioners.”3 A website from the Open
University (www.open.ac.uk) has an entry: “Self Advocacy
and Research: an analysis of the talk in inclusive
research with members of a People First group.” An
Australian article (www.vcoss.org.au) is entitled
“Inclusive research: The opportunities and challenges of
engaging and empowering diverse communities.” The Center
for the Study of Experimental Psychotherapy
(www.utoledo.edu) in its research protocol for a study
concerning “emotion-based treatment of depression” under
the category Clients/Patients” refers to “realistic
clinical populations (inclusive sample)” and “very limited
exclusion criteria: exclude psychotic, actively suicidal,
antisocial pd, current severe substance abuse/dependence
or other current severe crises.”

3 While applicant argues that the references to foreign
publications are irrelevant, the board has determined that these
articles can have some relevance. “[I]t is reasonable to assume
that professionals in medicine, engineering, computers,
telecommunications and many other fields are likely to utilize
all available resources, regardless of country of origin or
medium. Further, the Internet is a resource that is widely
available to these same professionals and to the general public
in the United States. Particularly in the case before us,
involving sophisticated medical technology, it is reasonable to
consider a relevant article from an Internet web site, in
English, about medical research in another country, Great Britain
in this case, because that research is likely to be of interest
worldwide regardless of its country of origin.” In re Remacle,
66 USPQ2d 1222, 1224 n.5 (TTAB 2002). These foreign articles
have some limited relevance in this case involving clinical
research services, although they are not critical to the result
here.
Ser. No. 78278816
8
Applicant argues (Brief at 5) that the examining
attorney’s evidence only serves “to show that INCLUSIVE
can be descriptive of certain research methodology in the
social sciences, they have no bearing on the issue of
whether INCLUSIVE is descriptive of applicant’s research.”
However, the evidence is not limited to the social
sciences. For example, a webpage for BioMechanics Lab4
describes it as a “source for basic and applied research.
Its mission is to design, test and evaluate new treatment
modalities that will advance the quality of patient care
and outcomes.” Among the lab features is “Inclusive
research and testing capabilities, combining design,
prototyping, macro and sub-micro scale material testing,
motion analysis, and finite element modeling.”
Another website from the Breast Cancer Forum5 contains
an article that is entitled “The Clinical Trial Dilemma:
How to Choose and Prioritize.” In discussing clinical
trials, it reports that the “FDA also imposes some
eligibility criteria and is very strict about who can take
new drugs and treatments.” The article proposes that a
“solution would be having a trial that is as inclusive as
possible. By testing a drug or treatment on a large

4 www.edtech.connect.msu.edu.
5 www.breastcancercenter.his.ucsf.edu.
Ser. No. 78278816
9
population, it would be determined how it affects a cancer
population as a whole.”
An article concerning the National Rural Health
Association (www.nhraural.org) contains the following
information: “Federal agencies that seek to promote more
‘population inclusive’ research should be instructed to
formally establish funding relationships with grant
programs.” Another website6 reports that: “There’s
growing attention being paid to gay and lesbian health
care issues, said Smith, with new group’s advocating
improved services and more inclusive research.” An
Ontario Public Health Association resolution
(www.opha.on.ca) explains that “the lack of comprehensive
and inclusive research and its dissemination results in
inequitable distribution of health care resources and
inaccessible, inappropriate and ineffective health
services for lesbians and gay men.”
A bulletin from the U.S. Department of State
(http://lists.state.gov) with the subject “HIV Vaccine
Trials Must Include Women, Teens, Experts Say” reports
that the World Health Organization “brought together this
panel of specialists to focus on the need to make the

6 www.valleyadvocate.com.
Ser. No. 78278816
10
composition of trial populations more inclusive and
broaden participation by gender, age and race… Clinical
trial enrollment needs to be more inclusive, so the
benefits of research are more fairly distributed.” The
American Heart Association website (www.ahajournals.com)
includes an article entitled “Heterogeneity of Stroke
Pathophysiology and Neuroprotective Clinical Trial
Design.” It indicates that: “Strategies to enhance the
proportion with tissue substrate for neuroprotection could
reduce sample size to 500 per group and simultaneously
reduce total number of patients screened compared with
inclusive trials.” Finally, the World Summit against
Cancer for the New Millenium (www.cancersafe.com) reports
that “the parties seek to enable rapid, powerful and
inclusive trials that ethically engage and also empower
people with cancer.”
This evidence lead us to conclude that the term
“inclusive” describes a characteristic, feature, or
attribute of applicant’s services of clinical research in
the filed of hypertension and anti-hypertensive
pharmaceuticals; medical and scientific research, namely,
conducting clinical trials for anti-hypertensive
pharmaceuticals. The term “inclusive” means “taking a
great deal or everything within its scope, comprehensive.”
Ser. No. 78278816
11
Applicant’s specimen describes a study that takes a great
deal within its scope.
The aim of INCLUSIVE, a prospective open-label,
single-arm study, was to determine the efficacy and
safety of irbesartan/HCTZ 150/12.5 mg and 300/25 mg
fixed combinations in a diverse population of adults
with systolic blood pressure (SBP) uncontrolled on
antihypertensive monotherapy. In addition to the
study’s overall enrollment, investigators also
actively sought to recruit at least 100 patients in
several predefined subgroups who have blood pressure
that is traditionally deemed difficult to control.

In addition, the “study started with 1005 patients (mean
age 57.2 +/- 11.2 years, 52% women) recruited at 119 sites
throughout the United States in line with the aim of the
study to recruit patients from subgroups with hard-to-
control blood pressure.” The groups that applicant’s
research was designed to include were those with metabolic
syndrome, type 2 diabetes, the elderly, African Americans,
and Hispanics/Latinos. Applicant’s research concerning
patients whose blood pressure is usually regarded as more
difficult to control falls within the dictionary
definition of “Inclusive.”
Applicant argues that its research “was not
comprehensive because it necessarily excluded the general
population who might otherwise have qualified to
participate in the study.” Brief at 6. However,
applicant’s study was inclusive because by its own
Ser. No. 78278816
12
definition, it was not a study of the general population
or even the general population with high blood pressure
but rather it was limited to patients whose blood pressure
is usually regarded as more difficult to control.
Applicant’s study certainly takes in a great deal within
its scope and, therefore, it is accurately described by
the term “inclusive.”
In addition, applicant argues (Brief at 5) that the
“examiner wrongly equates the meaning of “inclusive” with
meaning of “diverse.” Applicant’s argument rests heavily
on the point that its “clinical trial was not ‘inclusive,’
because it is a study of a drug on a limited population of
patients in certain sub-groups, not in a large population
of patients with high blood pressure as a whole.” Reply
Brief at 2. As discussed above, we have found this
general argument unpersuasive. Applicant also argues that
“diverse” is defined as “made up of distinct
characteristics, qualities, or elements.” Applicant’s
research, as its title demonstrates, is admittedly a study
involving a diverse patient universe (INCLUSIVE:
Irbesartan/HCTZ Blood Pressure Reductions in Diverse
Patient Populations). The issue of descriptiveness in
this case does not require that we find that “inclusive”
and “diverse” are synonyms. While the terms “inclusive”
Ser. No. 78278816
13
and “diverse” are not necessarily interchangeable, they
are certainly not unrelated. For instance, evidence that
a diverse population was included as part of the study
supports an argument that the research was inclusive. In
this case, if patients with metabolic syndrome or type 2
diabetes or those who were elderly, African American, or
Hispanic/Latino were excluded, the study would not have
included a diverse population and it would be unlikely to
be considered an inclusive study. The fact that
applicant’s study included a diverse population supports
the examining attorney’s position that the study is
described by the term “inclusive.”
Finally, applicant argues (Brief at 8) that its “mark
is an acronym for the subject matter of the clinical study
on hypertensive pharmaceuticals, and is not descriptive.”
There are several problems with applicant’s argument.
First, it is not clear that applicant’s term is an
acronym. An acronym is defined as “a word formed from the
initial letters or groups of letters of words in a set
phrase or series of words as Wac from Women’s Army Corps
or OPEC from Organization of Petroleum Exporting
Countries.” The Random House Dictionary of the English
Ser. No. 78278816
14
Language (unabridged) (2d ed. 1987).7 Applicant maintains
(Brief at 7) that the term INCLUSIVE is an acronym
composed of the highlighted letters from the following
phrase: “IrbesartaN/HCTZ bLood pressUre reductionS in
dIVErse patient populations.” Thus, it is composed of the
first and last letter of the first word, the second letter
of the next term (HCTZ), the second letter of the third
word, the sixth letter of the fourth term, the last letter
of the fifth term, and the third, fourth, and fifth
letters of the third to the last term. Applicant’s phrase
with the letters highlighted looks more like a ransom note
or a secret message rather than a traditional acronym.
This observation aside, we will assume for the
purposes of this decision, that prospective purchasers
will recognize applicant’s term, after studying
applicant’s literature, as an acronym. However, even
acronyms may be merely descriptive of an applicant’s goods
or services. See In re North American Free Trade
Association, 43 USPQ2d 1282, 1288 (TTAB 1997) (The
“evidence shows that NAFTA is an acronym for the North
American Free Trade Agreement, and applicant's identified

7 We take judicial notice of this definition. University of
Notre Dame du Lac v. J.C. Gourmet Food Imports Co., 213 USPQ 594,
596 (TTAB 1982), aff'd, 703 F.2d 1372, 217 USPQ 505 (Fed. Cir.
1983).
Ser. No. 78278816
15
services are the promotion of trade and investment in the
countries which are signatory to that trade agreement, and
the providing of advice regarding investments with respect
to the free trade area. Therefore, NAFTA is merely
descriptive of applicant's services, and must be
disclaimed”). The fact that applicant can make an acronym
of a descriptive or generic term does not eliminate the
term’s descriptive or generic significance. For example,
the term TIRE would remain generic for vehicle tires even
if an applicant argued that it used the term as an acronym
for Traction Improvement - Response Enhancer.
The term INCLUSIVE has a meaning that would be
immediately understood by prospective purchasers or users
of applicant’s identified clinical services, i.e., that its
services are comprehensive in nature. “The fact that
applicant may be the first and possibly the only one to
utilize this notation in connection with its services
cannot alone alter the basic descriptive significance of
the term.” In re Gould, 173 USPQ 243, 245 (TTAB 1972).
Decision: The examining attorney’s refusal to
register under Section 2(e)(1) of the Trademark Act is
affirmed.