IN THE UNITED STATES PATENT AND TRADEMARK OFFICE

In re Trademark Application of

Adams Respiratory Operations, Inc.

Serial No.: 77/111,490 : Trademark Examining Attorney
‘ Alice Benmaman
Filed: February 20, 2007
Law Of?ce 116
Mark: DESIGN
BLUE AND WHITE TABLET

RESPONSE TO OFFICE ACTION

Blue and White Tablet Functions as a Source Indicator

Drug capsule colors are capable of federal registration as a trademark. See, e. g., In re Star
Pharmaceuticals, 225 U.S.P.Q. 209 (T.T.A.B. 1985)(?nding that a multicolored drug capsule can
serve as a registerable trademark); In re American Home Products Corp, 226 U.S.P.Q. 327
(T.T.A.B. 1985) (holding that widespread distribution of the medicinal tablet, advertising and
promotion of the color combination of the medicinal tablet was suf?cient to establish secondary
meaning). The Of?ce Action concludes that the proposed mark is merely an ornamental or
decorative feature of the tablets. Essentially, the Of?ce Action concludes that the proposed mark is
not inherently distinctive or has not acquired secondary meaning. However, because of Adams’
exclusive and continuous use of the proposed mark, signi?cant advertising expenditures,
widespread distribution and promotional materials featuring the colors depicted in the proposed
mark, the public has come to recognize the proposed mark as a trademark and a source indicator.

Advertising expenditures, alone, can create a strong presumption of a color’s secondary
meaning. Roux Labs, Inc. v. Clairol Inc., 427 F.2d 823, 829 n. 10 (CCPA 1970). In In re Owens—
Corning Fiberglas Corp, an applicant, seeking trademark registration on the color pink applied to
?berglass insulation, spent approximately $42,421,000 on television, radio, newspapers, and
consumer magazines from 1972 to 1981, with an estimated $11,400,000 expenditure in 1981 alone.
774 F.2d at 1125. The Federal Circuit Court of Appeals, reversing the Of?ce’s decision to refuse
trademark registration, found that the applicant’s soaring advertising expenditures created a strong
presumption of secondary meaning. Id. at 1128.

Indeed, other courts, in granting rights to register a color as a trademark, have found that
advertising expenses are strong evidence of secondary meaning. See, e.g., In re Hehr Mfg. Co., 279
F.2d 526, 528 (CCPA 1960) (?nding that $112,000 spent over six year period was suf?cient to
show secondary meaning); In re Am. Home Prods. Corp, 226 U.S.P.Q. at 330 (noting that
$8,000,000 spent between 1960 and 1980 suf?ced); but see In re Star Pharms., Inc., 225 U.S.P.Q.
at 209 (?nding that $250,000 spent over ?ve years was insuf?cient).
In the instant situation, Adams has been distributing and selling blue and white tablets,
exclusively and continuously, under the name (i) MUC]NEX® since July 2002, (ii) MAXIMUM
STRENGTH MUCINEX® since July 2007, and (iii) HUMBID® fromMarch 2006 to May 2007
(collectively, the “Products”). See Af?davit of Brad Cole (hereinafter Cole Af?davit) 11 3. Since
the ?rst sale of each of the products, Adams has spent approximately $85,872,710 on advertising
expenditures for the blue and white tablets distributed and sold under the mark MUCINEX®,
MAXIMUM STRENGTH MUCINEX® and HUMIBID®. See Cole Af?davit 11 6. Advertising for
the blue and white tablets speci?cally includes consumer advertising, professional advertising and
consumer promotions. See Cole Af?davit 11 7. Because of Applicant’s advertising expenditures
alone, there is a strong presumption of secondary meaning. See Roux Labs, Inc, 427 F.2d 823, 829
n. 10 (CCPA 1970).

In addition to advertising expenditures, widespread use or distribution of the product bearing
the proposed mark can demonstrate an acquired secondary meaning. See, e.g., In re Am. Home
Prods. Corp, 226 U.S.P.Q. at 330 (?nding that when distribution of samples between 1972 and
1980 exceeded 69,000,000 tablets, there existed at least some presumption of secondary meaning);
but see In re Star Pharms., Inc, 225 U.S.P.Q. at 210, 212 (?nding that $1,000,000 in sales volume
over ?ve years was insuf?cient to establish any acquisition of distinctiveness).

Here, Applicant has been has been distributing and selling blue and white tablets,
exclusively and continuously, under the name (i) MUCINEX® since July 2002, (ii) MAXIMUM
STRENGTH MUCINEX since July 2007, and (iii) HUMBID from March 2006 to May 2007. See
Cole Af?davit 11 3. Since the ?rst sale of each of the Products, Adams has exclusively and
continuously distributed and sold approximately 1,596,008,899 blue and white tablets under the
mark MUCINEX® to MAXIMUM STRENGTH MUCINEX® and HUMIBID® to wholesalers and
various retailers including mass merchandisers, chain food & drug stores, wholesale food & drug
stores, specialty pharmacies and wholesalers. See Cole Af?davit 11 5.

An applicant may demonstrate that a color has achieved secondary meaning by presenting
evidence that the color has been, or is currently, featured in the applicant’s promotional materials.
In re Owens—Corning Fiberglas Corp, 774 F.2d at 1126-27. In In re Owens-Corning Fiberglas
Corp, the Federal Circuit found that continued references to the pinkness of the ?berglass
insulation, including commercials that prominently featured the Pink Panther, were strong evidence
that the color had acquired distinctiveness or secondary meaning. Id. Furthermore, in In re
American Home Products, the Trademark Trial and Appeal Board found that an applicant’s use of
packaging that mirrored the colored layers of the enclosed tablets was strong evidence of an
acquired distinctiveness. 226 U.S.P.Q. at 330. On the other hand, in In re Star Pharmaceuticals,
Inc. , the court noted that promotional materials that featured black and white representations of
multi-colored capsules severely undermined the applicant’s argument that the colors had acquired
secondary meaning. 225 U.S.P.Q. at 212.

Here, Applicant’s packaging prominently features full color representations of the product.
Furthermore, as in In re American Home Products, Applicant has fashioned its products’ box
designs to mirror the blue and white, patterns of the enclosed capsules. 225 U.S.P.Q. at 212. In
addition, Applicant’s consumer advertising, professional advertising and consumer promotions
prominently displays the blue and white tablets. See Cole Af?davit 11 7.
The Color ofthe Mark is not Functional

The Of?ce Action points out, colors that “yield a utilitarian or functional advantage” are not
registrable. TMEP § 1202.05(b). Arguments that a color is not functional typically—and
understandably—vary by context. See J. THOMAS MCCARTHY, MCCARTHY ON TRADEMARKS AND
UNFAIR COMPETITION § 7:49 (West 2007). In the context of drug capsule colors, applicants seeking
federal trademark registration must generally show that (1) the colors are not a natural by-product of
the manufacturing process and (2) the colors do not indicate the type of drug. Id.

The Colors Do Not Occur Naturally

Colors that result as a natural by-product of the manufacturing process are not registrable as
trademarks. Id. Courts ?rmly enforce this restriction so that competitors, who are consequently
obliged to arti?cially color their products, are not place (1 at a competitive disadvantage relative to
the registrant. Id. In Marion Laboratories, Inc. v. Michigan Pharmacal Corp, the court held that
brown and clear multi-colored capsules were not functional because the capsules were made of a
gelatin that could take on any color or opaqueness. 338 F. Supp. 762, 766—67 (E.D. Mich. 1972).

Here, the blue and white color of the tablets is not a natural by—product of the manufacturing
process. See Cole Af?davit 8. The blue and white color the tablets possess are a result of the
addition of speci?c dye that is added during the manufacturing process. See Cole Af?davit 9.
Speci?cally, a FD & C blue #1 aluminum lake dye is added to create the blue and white color on the
tablets. See Cole Af?davit 10. The FD &C blue #1 aluminum lake dye is listed as an active
ingredient on the product packaging for the blue and white tablets. See Cole Af?davit 11. Because
the color feature of the mark is not naturally occurring, the blue and white color of the proposed
mark does not serve a utilitarian function and thus, the proposed mark is registerable on the
Principle Register.

The Colors Are Not an Indicator of the Type of Drug

Courts have suggested that colors that identify the type of medication, regardless of the
medication’s source, are generally not registrable. MCCARTHY, supra, at § 7:50. The underlying
argument is that trademark registration of a colored capsule or tablet could potentially confuse
consumers who use color to identify the general type of drug, such as a heart or blood medication.
Id. Nonetheless, courts have scarcely found that end-users, within the pharmaceutical industry, use
speci?c color combinations to identify the type of drug. See, e.g., SK&F, Co. v. Premo Pharm.
Labs, 625 F.2d 1055, 1064 (3d Cir. 1980) (?nding that an orange tablet was not functional because
there was no evidence that diuretics were identi?ed in the industry as such); but see Shire US Inc. v.
Barr Labs, Inc., 329 F.3d 348, 353—59 (3d Cir. 2003) (?nding that colors functioned to identify
correct dosages and ensure patients’ approval of generic substitutions).

Here, the blue and white color combination is not generally indicative of expectorants in the
pharmaceutical industry. In fact, the color combinations used by Applicant are unique’ to
Applicant’s products and consumers do not use those colors to identify expectorants generally but
to identify Applicant’s products alone. In fact, the color combinations used by Applicant are unique
to Applicant’s products and consumers do not use those colors to identify expectorants generally
but to identify Applicant’s products alone. See Cole Af?davit W l2-l4. Consequently, the only
purpose for the blue and white color is to serve as a source indicator for Adams’ MUCINEX®,
MAXIMUM STRENGTH MUCINEX® and HUMIBID® tablets. See Cole Af?davit 1] 12.

Additional Information

See Attached Affidavit of B. Cole

Drawing ofthe Mark

A substitute drawing of the mark has been submitted. The substitute drawing

presents a single three-dimensional view of the tablet showing solid lines of the entire tablet. A

separate drawing of the mark is submitted contemporaneously with the electronic response to the

Of?ce Action.

Description ofthe Mark

Applicant agrees and adopts the Examiner’s suggested description of the mark, as

follows:

The mark consists of the color blue and white as applied to the bi-layer guaifenesin
extended-release tablets with blue on top for extended relies and white on bottom indicating
immediate release.

Specimen

Applicant submits a JPG photograph of the actual blue and white tablet. In addition,

Applicant submits an electronic declaration verifying that the specimen was in use in commerce at

least as early as the ?ling date of the application.
Conclusion

Having fully responded to the issues raised in the of?ce action, Applicant requests that the

mark be approved for publication as soon as possible.

Respectfully submitted,

WWW
Debra Deardourff Faulk
HOLLAND & KNIGHT LLP
PO. Box 1288
Tampa, FL 33601-1288
Attorney for Applicant
Telephone: (813) 227-8500
Email: [email protected]

# 494245l _vl
IN THE UNITED STATES PATENT AND TRADEMARK OFFICE

In re Trademark Application of

Adams Respiratory Operations, Inc.

Serial No.: 77/ l 1 1,490 , : r. ,. Trademark Examining Attorney
Alice Benmaman
Filed: February 20, 2007
Law Office 116
Mark: BLUE AND WHITE TABLET

AFFIDAVIT OF BRAD COLE IN SUPPORT OF RESPONSE TO OFFICE ACTION

STATE OF NEW JERSEY )

COUNTY OF MORRIS 3

BEFORE ME , the und ers ign ed aut hor ity per son all y app ear ed BR AD CO LE , wh o aft er

being duly sworn, states as follows:

1. My name is Brad Cole. I am more than 21 years of age and have personal

knowledge of the facts herein.

2. I am the Ass oci ate Gen era l Cou nse l for Ad am s Res pir ato ry Ope rat ion s, Inc . d/b /a

Adams Respirato ry The rap eut ics , Inc. (“A dam s”) . I hav e bee n emp loy ed by Ada ms sin ce Oct obe r,

2004.

3. Adams has been distributing and selling blue and white tablets, exclusively and

continuou sly , und er the nam e (i) MU CI NE X® sin ce Jul y 200 2, (ii) MA XI MU M ST RE NG TH

MUCINEX sin ce Jul y 200 7, and (iii ) HU MB ID fro m Mar ch 200 6 to Ma y 200 7 (col lect ivel y, the

“Products”).

4. The blue and white tablets consist of bi-layer guaifenesin extended release tablets

with blue on top for extended releaSe and white on bottom indicating immediate release.
5. Since the ?rst sale of each of the Products Adams has exclusively and continuously

distributed and sold approximately 1,599,754,966 blue and white tablets under the mark

MUCINEX® to MAXIMUM STRENGTH MUCINEX® and HUMIBID® to wholesalers and

various retailers including mass merchandisers, chain food & drug stores, wholesale food & drug

stores, specialty pharmacies and wholesalers.

6. Since the ?rst sale of each of the products Adams has spent approximately

$85,872,710 on advertising expenditures for the blue and white tablets distributed and sold under

the mark MUCINEX®, MAXIMUM STRENGTH MUCINEX® and I‘iUMlBID.

7. Advertising for the blue and white tablets Speci?cally includes consumer advertising,

professional advertising and consumer promotions. See Exhibit A.

8. The blue and white color of the tablets is not a natural by-product of the

manufacturing process.

9. The blue and white color the tablets posses are a result of the addition of speci?c dye

that is added during the manufacturing process.

10. Speci?cally, a FD&C blue #1 aluminum lake dye is added to create the blue and

white color on the tablets.

l 1. The FD&C blue #1 aluminum lake dye is listed as an active ingredient on the

product packaging for the blue and white tablets. See Exhibit B.

12. The only purpose of the blue and white color tablets is to serve as a source indicator

for Adams’ MUCINEX®, MAXIMUM STRENGTH MUCINEX® and HUMIBID® tablets.

13. To my knowledge, other companies distributing and selling bi-layer guaifenesin

tablets are not using the blue and white color for tablets.
l4. To my knowledge, the blue and white color combination is unique to Adams’

MUCINEX®, MAXIMUM STRENGTH MUCIN EX® and HUMIBID® products and consumers do not

identity cough expectorants generally by blue and white tablets.

AFFIANT SAY NOTHING FURTHER.

?a/
Brad Cole

STATE 01“ NEW JERSEY

COUNTY OF MORRIS

The foregoing instrument was subscribed and sworn to beforc me on November 20, 2007 by Brad
Cole, who is personally known to me.
(SEAL)
Printed/’l‘ypcd Name:
Notary Public—State ochw Jersey KA‘I‘HERINE MacFARLANE
Commission Number: NOTARY PUBLIC ill NEW JERSEY
, MY COMMISSW“ WW” ‘5 :’=tlt‘:llST18.2003
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EXHIBIT
IRST. LET’S CLEAR UP THE CONEUSION HOW CAN THE MUCINEX FAMILY OF WHAT SHOULD YOU EXPECT
– BOUT MUCUS PRODUCTS HELP CLEAR CONCESTION. FROM MUCINEX ?
RELIEVE COUCH. ANO EASE SINUS PRESSURE?
:”x/l 1., 1 ‘3‘ 12-hour!
release ‘ Extended-release

Mu ci ne x
MUClNEX IN. MUCH! OUT.

SPECIAL MAIL-IN REBATE
,» s . .,
f – _ INJQUI w ‘n. wr
UCINEX BREAKS UP THE MUCUS THAT Extended4mease ‘g It.
‘USES CONCESTION 2A ‘5’! -u‘

Mail to: Dept. 56944
Mucinex 52/54 MIR
PO. Box 134
Niagara Falls. NY 14302-0134
Check Item purthasea (check 05Ty one)
.1 Mucinex 20-count tablets
_| Mucinex 40-count tablets
‘Ml; M I‘ ‘
:1 Mucinex 100-(ount tablets
‘vl’ v,”
CI Mucinex DM 20-count tablets
CONBESTED AIMAV CLEAR WAY [:1 Mucinex DM 40—(ount tablets
MucinexD LJ Mucinex D18-(ount tablets
‘ EXPECTORANIl?ECORGESfANI 4 0..
hr- Lcmmon mth mun-(Merl! ,il‘ lglllr inf}.
) ll’ILIL’:. qt. t}Lln|I9l‘}n_3′,Ilv 7 v 12«hour
huh leI 100an HUMAN e Extended~release
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hill VUU IdI r‘ IVHL‘E‘ 6! {Ir‘l‘a‘

ablet has ‘i Wl’nlr” mm I F0! Custamer Sew-(e. lease (all us toll he: at I-vaUCINEX,
Terms and Conditions :Ls ‘ v: .‘ – :.,‘ .’ .. –
(486593 Meade:le urmteclmlel; .wn’ :1 r

:yer this! wmks stemlul‘ 1c” 13 l’umr’.
4UCINDI [)IOUULI’; (Ol’lrhW lul’wm
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D_r_u_ (c_on_ti_nu_ed_)____._————
Stop use and ask a doctor if
I . ‘
I . ‘ V I h ’
I coug h last s mo re th an 7 da ys , co me s ba ck , or
1“”

l e a s e Purpose occurs wi th feve r, ra sh , or pe rs is te nt he ad ache .
d e x t r o tho r pha n H Br 2.2%290 % ;7 3 5 2 : 1 5 4 8 a se ri ou s il ln es s.
600 m g g u a i f e e s m a n d 3 0 m g Thes e co ul d be si gn s of
extended-release bi-Iayer tablets “Jaye, tablet) If pregnant or breast-feeding, ask a health
Dextromethorph an HB r 30 mg .. … … .. Co ug h su pp re ss an t professional before use.
EXPECTORANT Keep out at re ac h of ch il dr en . In ca se of ov er do se ,
Guaifenesin 60 0 m g .. .. . .. .. .. .. .. .. .. .. .. .. .. .. .. Ex pectorant
IC O U G H S U P P R E S S A N T get medical help or cont ac t a Po is on Co nt ro l Ce nt er
right away.
Uses I he lp s lo os en ph le gm (m uc us ) an d thin
bronchial secretio ns to ri d th e br on ch ia l pa ss ag ew ay s
ti ve
Directions
of bothersome mucus an d m a k e co ug hs mo re pr od uc
I do not crush, chew, or break tablet
I temporarily relieves: I take with a full glass of water
I cough due to mi no r th ro at an d br on ch ia l ir ri ta ti on ad mi ni st er ed wi th ou t re ga rd fo r
I this produc t ca n be
as may oc cu r wi th th e c o m m o n co ld or in ha le d
timing of meals
irritants I adults an d chil dr en 12 ye ar s an d ol de r: on e or
I the intensity of coughing two tablets ev er y 12 ho ur s; no t mo re th an 4t ab le ts
I the impulse to co ug h to he lp yo u ge t to sl ee p
in 24 hours
I childr en un de r 12 ye ars of ag e: do no t us e
Warnings ,
Do not use I fo r ch il dr en un de r 12 ye ar s of ag e Other information
I tamper ev id en t: do no t use if se al on bo tt le pr in te d
I if you are n o w ta ki ng a pr es cr ip ti on m o n o a m i n e
“SEALED for YO UR PR OT EC TI ON” is broken or missing
oxidas e in hi bi to r (M AO I) (c er ta in dr ug s fo r
na l co nd it io ns , I st or e at 20-2 5° C (B B- 77 °F )
depression , ps yc hi at ri c or em ot io
or Parkinson‘s di se as e) , or fo r 2 w e e k s af te r NF;
ur Inactiv e i n g r e d i e n t s carbomer 934p,
stopping th e M A O I dr ug . It yo u do no t k n o w if yo P;
D&C yellow #10 al um in um lake ; hy pr om el lo se , US
prescription dr ug co nt ai ns a MA Ol , as k a do ct or os e, NF ;
magnesium stearate, NF ; micr ocry stalli ne ce ll ul
or pharma ci st be fo re ta ki ng th is pr od uc t.
____ _ _ _ . _ _ _ _ _ _ — — ——- sodium starch glycolate, NF
Ask a d o c t o r b e f o r e u s e if y o u h a v e
I persistent or ch ro ni c co ug h su ch as oc cu rs wi th US Pat. 6,372,252 B1
smoking, asthma, ch ro ni c br on ch it is , or e m p h y s e m a Distributed by US Pat. 6,955,821 82
I cough acco mp an ie d by to o m u c h ph le gm (m uc us ) AK )‘Vx‘tix
please visit __________ _ _ _ _ _ _ _ _ _ — — — —
RESPIRATORY
When using this product THERAPEUTICS” 011206
our Web site: r e t h a n d i r e c t e d p CHESTER. N) 07930
m I do n o t u s e m o
www.mu c i n ex _ co 2005621
/
EXHIBIT‘
Drug Facts (continued)
Drug Facts Stop use and ask a doctor it
I cough lasts more than 7 days, comes back, or
zzifcjrggg?gm?se Purpose occurs with fever, rash, or persistent headache
600 mg guéitenesin and 30 mgjdextromethorphan HBr These could be signs at a serious illness.
extendedrelease bi-layer tablets “Jaye, tablet) lt pregnant or breast-teeding, ask a health
EXPECTORANT Dextromethorphan HBr 30 mg …….. ,.Cough suppressant prolessional betore use.
Guatlenesinsoomg ……………………….. ..Expectorant Keep out of reach at children. in case of overdose,
COUGH SUPPRESSANT
get medical help or contact 3 Poison Control Center
right away.
Uses I helps loosen phlegm (mucus) and thin
bronchial secretions to rid the bronchial passageways Directions
ot bothersome mucus and make coughs more productive I do not crush, chew, or break tablet
I temporarily relieves: I take with a full glass of water
I cough due to minor throat and bronchial irritation I this product can be administered without regard for
as may occur with the common cold or inhaled timing of meals
irritants I adults and children 12 years and older: one or
I the intensity ot coughing two tablets every 12 hours; not more than 4 tablets
I the impulse to cough to help you get to sleep in 24 hours
I children under 12 years of age: do not use
WM~~ ED
– ‘A TE i
-..__.._r,. .2 J
c ,FNF—NPEE Warnings
RELEASE Do not use I tor children under 12 years of age Other information
RELEASE
LAYER I it you are now taking a prescription monoamine I tamper evident: do not use it seal on bottle printed
LAYER -> I
oxidase inhibitor (MAUI) (certain drugs tor “SEALED tor YOUR PROTECTION“ is broken or missing
‘
depression, psychiatric or emotional conditions, I store at 20-25°C (BB-77°F)
or Parkinson’s disease). or for 2 weeks after ‘ I
stopping the MAOI drug. It you do not know it your Inactive ingredients caibomer 9349. NF;
prescription drug contains a MAOI, ask a doctor 0&8 yellow #10 aluminum lake; hypromellose, USP;
or pharmacist betore taking this product. magnesium stearate, NF; microcrystalline cellulose, NF;
sodium starch glycolate, NF
Ask a doctor More use it you have
I persistent or chronic cough such as occurs with US Pat. 6,372,252 B1
smoking, asthma, chronic bronchitis, or emphysema Distributed by US Pat. 6,955,821 32
I cough accompanied by too much phlegm (mucus) Ali-Mx
Please visit
RESPIRATORY
our Web S ite: When using this product THERAPEUTICS” 011206
I do not use more than directed p CHESTER N) 07930
www.mucinexcorn 2005621
/ D