Petition To Revive For Office Action
`
`Page 1 of 9
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`PTO Form 2194 (Rev 9/2005)
`
`OMB No. 0651-0054 (Exp. 11/30/2008)
`
`Petition To Revive For Office Action
`
`The table below presents the data as entered.
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`ORIGINAL
`PDF FILE
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`§3§;IEL‘]‘Eg‘3)D
`(13 Pages)
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`'
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`http://tgate/PDF/POA/2008/06/10/20080610151126796925-
`77049554-0O9_00l/evi_216767l-
`150348571_._amendment.PDF
`
`\\TICRS\EXPORT\IMAGEOU'l\770\495\77049554\xml2
`‘fllfilllllfl
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`\\TICRS\EXPORT\IMAGEOUT\770\495\77049554\xml2
`\POAOO03.JPG
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`\\TICRS\EXPORT\IMAGEOUT\770\495\77049554\xml2
`\POAO004.JPG
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`\\TICRS\EXPORT\IMAGEOUT\770\495\77049554\xml2
`\POA0005 JPG
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`\\TICRS\EXPORT\IMAGEOUT\770\495\77049554\xml2
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`\\TICRS\EXPORT\IMAGEOUT\770\495\77049554\xml2
`\POA0007.JPG
`-
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`file ://\\ticrs-ais-01\ticrs expoIt\HtmlToTifiInput\POA0O0 12008_06_13_l2_0 1__3 0_TTABO...
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`6/13/2008
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`Invwield
`SERIAL NUMBER
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`77049554
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`LAW OFFICE ASSIGNED
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`LAW OFFICE 103
`
`DATE OF NOTICE OF
`ABANDONMENT
`
`PETITION
`
`06/1°/2°08
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`
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`
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`PETITION STATEMENT
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`
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`RESPONSE TO OFFICE ACTION
`
`MARK SECTION (no change)
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`EVIDENCE SECTION
`
`Applicant has firsthand knowledge that the failure to
`respond to the Office Action by the specified deadline was
`unintentional, and requests the USPTO to revive the
`abandoned application.
`
`

`
`Petition To Revive For Office Action
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`Page 2 of 9
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`\\TICRS\EXPORT\IMAGEOUT\770\495\77049554\xml2
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`\\TICRS\EXPORT\IMAGEOU'I‘\770\495\77049554\xml2
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`\\TICRS\EXPORT\IMAGEOU'I\770\495\77049554\xm12
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`\\TICRS\EXPOR”[\1MAGEOUT\770\495\77049554\xm12
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`ORIGINAL
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`my FILE
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`§§§;EE1g§)D
`(7 pages)
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` http://tgate/PDF/POA/2008/06/ 10/200806 1 01 5 1 12679692 5-
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`77049554-0O9_002/evi_2167671-150348571_._ex_a.PDF
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`\\TICRS\EXPOR'I’\IMAGEOUT\770\495\77049554\xml2
`\_POA0015.JPG
`~—j
`_
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`\\TICRS\EXPORT\IMAGEOUT\770\495\77049554\xml2
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`\\TICRS\EXPORT\IMAGEOIJ”I\770\495\77049554\xm12
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`\POA0020.JPG
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`\\TICRS\EXPORT\IMAGEOL"I\770\495\7704954\xml2
`\POAO 02 1 .JPG
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`http://tgate/PDF/POA/2008/06/ 10/200806101 5 1 126796925-
`77049554-009_003/eVi_2167671-150348571_._ex_b.PDF
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`\\TICRS\EXPOR'I‘\IMAGEOUT\770\495\77049554\xml2
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`\\TICRS\EXPOR'I‘\IMAGEOUT\770\495\77049554\xml2
`\POAOO23.JPG
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`\\TICRS\EXPORT\IMAGEOUT\770\495\77049554\xml2
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`1‘.fl‘)’F1T‘:EILI;‘('f)"
`(3 page3)
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`file://\\ticrs-ais-01\ticrsexport\HtmlToTiffInput\POA00012008_06__13_12_01_30__'ITABO...
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`6/13/2008
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`

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`Petition To Revive For Office Action
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`Page 3 of 9
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`\POAO024..TPG
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`http://tgate/PDF/POA/2008/06/10/20080610151126796925-
`77049554-009_004/eVi_2167671—150348571__._ex_c.PDF
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`\\TICRS\EXPOR'I'\IMAGEOUT\770\495\77049554\xm12
`‘_P
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`\\TICRS\EXPORT\IMAGEOUT\770\495\77049554\xml2
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`\\TICRS\EXPOR’I'\IMAGEOUT\770\495\77049554\xm12
`\POAOO27.JPG
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`\\T1CRS\EXPORT\IMAGEOUT\770\495\77049554\xm12
`\POA0028..TPG
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`http://tgate/PDF/POA/2008/O6/10/20080610151126796925-
`77049554-009_005/evi_2 167671 -150348571_._ex_d.PDF
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`\\TICRS\EXPORT\IMAGEOUT\770\495\77049554\xml2
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`\\TICRS\EXPORT\IMAGEOU'I\770\495\77049554\xm12
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`\\TICRS\EXPORT\IMAGEOUT\770\495\77049554\Xml2
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` http://tgate/PDF/POA/2008/06/ 10/200806 1 015 1 126796925-
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`\\TICRS\EXPORT\IMAGEOU"I\770\495\77049554\xm12
`\POA0032.JPG
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`77049554-009_006/eVi_2167671-15034857l_._ex_e.PDF
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`\\TICRS\EXPORT\IMAGEOUT\770\495\77049554\xml2
`\POA0033 .JPG
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`\\TICRS\EXPORT\IMAGEOUT\770\495\77049554\Xml2
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`_
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`\\TICRS\EXPORT\IMAGEOU'I\770\495\77049554\xml2
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`\\TICRS\EXPORT\IMAGEOUT\770\495\77049554\xml2
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`\\TICRS\EXPORT\IMAGEOUT\770\495\77049554\xm12
`\POA0037.JPG
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`\\TICRS\EXPORT\IMAGEOUT\770\495\77049554\xm12
`\POA0038..TPG
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`http://tgate/PDF/POA/2008/06/ 10/200806101 51126796925-
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`ORIGINAL
`PDF FILE
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`1E§§§TEL‘;g‘3)”
`(4 pages)
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`ORIGINAL
`pmr FILE
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`(3 pages)
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`ORIGINAL
`PDF FILE
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`(7 pages)
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`ORIGINAL
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`PDF FILE
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`file://\\ticrs-ais-01\ticrsexport\HtmlToTifiInput\POA00012008_06_13_12_01_30_TTABO...
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`6/13/2008
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`

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`Petition To Revive For Office Action
`
`I
`
`A
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`Page 4 of 9
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`77049554-009_O07/evi_2167671-150348571_._ex_f.PDF
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`CONVERTED
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`(5 pages)
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`PDF FILES)
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`j‘j.'————
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`http://tgate/PDF/POA/2008/06/ 1 O/200806 1 O1 5 1 12679 6925-
`77049554-OO9_008/evi_2167671-15034857l_._ex_g.PDF
`
`PDF mE(S)
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`‘
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`'
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`\\TICRS\EXPORT\IMAGEOUT\770\495\77049554\xml2
`\POA0045 ..IPG
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`\\TICRS\EXPORT\IMAGEOUT\770\495\77049554\xml2
`\POA0O46.JPG
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`ORIGINAL
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`PDF FILE 77049554-0O9_O09/evi_2167671-15034857l_._ex_h.PDF
`
`CONVERTED
`PDF FILE“)
`(4 pages)
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`\\TICRS\EXPORT\IMAGEOU'I\770\495\77049554\xml2
`\P0 A0047 JPG
`é——'~——
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`http://tgate/PDF/POA/2008/06/ 10/200806 l 01 5 1 126796925-
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`\\TICRS\EXPORT\IMAGEOUT\770\495\77049554\xml2
`\POA0048..TPG
`-
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`\\TICRS\EXPORT\IMAGEOUT\770\495\7704954\xml2
`\POAOO49.JPG
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`\\TIC RS\EXPORT\IMAGEOUT\770\495\77049554\xml2
`\POAO050.JPG
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`DESCRIPTION OF EV1])ENCE FILE
`
`Amendment and Exhibits A-H
`
`GOODS AND/OR SERVICES SECTION (current)
`
`1
`
`INTERNATIONAL CLASS
`
`010
`
`DESCRIPTION
`
`ORALLY OR RECTALLY ADMINISTERED SUPPOSITORIES, SUSPENSIONS, GELS, FAST
`MELT TABLETS, ORALLY DISINTEGRATING TABLETS AND ORALLY DISINTEGRATING
`WAFERS CONTAINING A MUCOSAL BARRIER PREPARATION FOR THE TREATMENT OF
`
`file://\\ticrs-ais-O1\ticrsexport\HtmlToTifiInput\POA00O12008__06_13_12_01_30_TTABO...
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`6/13/2008
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`ORIGINAL
`PDF FILE
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`CONVERTED
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`(3 pages)
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`\\TICRS\EXPORT\IMAGEOUT\770\495\77049554\Xm12
`\POA0040.JPG
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`\\TIC RS\EXPORT\IMAGEOUT\770\495\77049554\Xml2
`\POA0O4l JPG
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`\\TICRS\EXPORT\IMAGEOUI\770\495\77049554\xml2
`\POA0O42..IPG
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`\\TICRS\EXPORT\IMAGEOUT\770\495\77049554\Xml2
`\POAO043 .JPG
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`
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`

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`Petition To Revive For Office Action
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`Page 5 of 9
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` ULCERATIVE CONDITIONS OF THE OROPHARYNGEAL, ESOPHAGEAL, RECTUM OR
`
`
`
`
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`
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`GASTROINTESTINAL TRACT; VAGINALLY OR GENITOURINARY ADMINISTERED
`CREAMS, OINTMENTS, LOTIONS, GELS, INSERTS AND SUPPOSITORIES CONTAINING
`PHARMACEUTICAL PREPARATIONS FOR THE TREATMENT OF VAGINAL OR
`GENITOURINARY TRACT DISEASES; MEDICAL DEVICES, NAMELY, SUPPOSITORIES,
`SUSPENSIONS, GELS, FAST MELT TABLETS, ORALLY DISINTEGRATING TABLETS,
`ORALLY DISINTEGRATING WAFERS, CREAMS, OINTMENTS, LOTIONS, GELS, OR
`INSERTS FOR DISAGNOSING OR TREATING DISEASES OF THE ORAL CAVITY, TONGUE,
`THROAT, PHARYNX, NASAL PASSAGES, SINUSES, ESOPHAGUS, STOMACH,
`INTESTINAL TRACT, OR RECTUM
`
`
`
`Section 100
`GOODS AND/OR SERVICES SECTION (proposed)
`
`
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`
`
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`INTERNATIONAL CLASS
`
`010
`
`DESCRIPTION
`
`ORALLY OR RECTALLY ADMINISTERED SUPPOSITORIES, SUSPENSIONS, GELS, FAST
`MELT TABLETS, ORALLY DISINTEGRATING TABLETS AND ORALLY DISINTEGRATING
`WAFERS CONTAINING A MUCOSAL BARRIER PREPARATION FOR THE TREATMENT OF
`ULCERATIVE CONDITIONS OF THE OROPHARYNGEAL, ESOPHAGEAL, RECTUM OR
`GASTROINTESTINAL TRACT; VAGINALLY OR GENITOURINARY ADMINISTERED
`CREAMS, OINTMENTS, LOTIONS, GELS, INSERTS AND SUPPOSITORIES CONTAINING
`PHARMACEUTICAL PREPARATIONS FOR THE TREATMENT OF VAGINAL OR
`GENITOURINARY TRACT DISEASES; MEDICAL DEVICES, NAMELY, SUPPOSITORIES,
`SUSPENSIONS, GELS, FAST MELT TABLETS, ORALLY DISINTEGRATING TABLETS,
`ORALLY DISINTEGRATING WAFERS, CREAMS, OINTMENTS, LOTIONS, GELS, OR
`INSERTS FOR DIAGNOSING OR TREATING DISEASES OF THE ORAL CAVITY, TONGUE,
`THROAT, PHARYNX, NASAL PASSAGES, SINUSES, ESOPHAGUS, STOMACH,
`INTESTINAL TRACT, OR RECTUM
`
`PAYMENT SECTION
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`Section 10»
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`TOTAL AMOUNT
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`TOTAL FEES DUE
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`SIGNATURE SECTION
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`100
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`
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`The filing Attorney has elected not to submit the signed
`declaration, believing no supporting declaration is required
`under the Trademark Rules ofPrac1ice.
`
`DECLARATION SIGNATURE
`
`
`
`
`RESPONSE SIGNATURE
`
`/pjh/
`
`SIGNATORY'S NAME
`
`Peter J. Hardin
`
`Attorney °fRe<=°rd
`06/1°/2008
`
`
`
`
`
`file ://\\ticrs-ais-01\ticrsexport\HtmlToTifiInput\POAO00 l2008_O6__13_12_0 1_30_TTABO...
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`6/13/2008
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`

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`Petition To Revive For Office Action
`
`Page 6 of 9
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`AUTHORIZED SIGNATORY
`
`FILING INFORMATION SECTION
`
`10150348571587
`
`TEAS STAMP
`
`Tue Jun 10 15=11=26 EDT 2008
`' USPTO/POA-216.76.7.1-2008
`0610151126796925-77049554
`-4208fcc949f85b6524ecea07
`f1e5b807c9d-DA-471-200806
`
`PTO FDrr'n 2194 (Rev 9/2005)
`
`OMB No. 0651-0054 (Exp. 11/30/2008)
`
`Petition To Revive For Office Action
`
`To the Commissioner for Trademarks:
`
`Application serial no. 77049554 has been amended as follows:
`PETITION
`Petition Statement
`
`Applicant has firsthand knowledge that the failure to respond to the Office Action by the specified
`deadline was unintentional, and requests the USPTO to revive the abandoned application.
`
`RESPONSE TO OFFICE ACTION
`
`EVIDENCE
`Evidence in the nature of Amendment and Exhibits A-H has been attached.
`
`Original PDF file:
`http://tgate/PDF/POA/2008/06/10/20080610151126796925-770495 54-009_001/evi_2167671-
`150348 57 1_.__amendment.PDF
`Converted PDF file(s) (13 pages)
`Evidence-1
`Evidence-2
`Evidence-3
`Evidence-4
`
`Evjdle-5
`Evidence-6
`Evidence-7
`Evidence-8
`Evidence-9
`Evidence- 10
`Evidence-11
`Evidence- 12
`Evidence- 13
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`file ://\\ticrs-ais-01\ticrsexpo1t\HtmlToTifi'Input\POA000 12008_06_13_12_O 1_3 0_TTABO...
`
`6/ 1 3/2008
`
`

`
`Petition To Revive For Office Action
`
`Page 7 of 9
`
`Original PDF file:
`http://tgate/PDF/POA/2008/06/10/20080610151126796925-77049554—009_002/evi_2167671-
`150348571_._ex_a. PDF
`Converted PDF file(s) (7 pages)
`Evidence- 1
`Evidence-2
`Evidence-3
`Evidence-4
`Evidence- 5
`Evidence-6
`Evidenc e-7
`
`Original PDF file:
`http://tgate/PDF/POA/2008/06/10/20080610151126796925-77049554-009_003/evi_2167671-
`150348571_._ex_b.PDF
`Converted PDF file(s) (3 pages)
`EVidenc_e_-_1
`Evidence-2
`Evidence-3
`
`-
`Original PDF file:
`http://tgate/PDF/POA/2008/06/10/2008061015 1126796925-77049554-009_0O4/evi_2167671-
`150348571_._ex_c.PDF
`Converted PDF file(s) (4 pages)
`Evidenc e- 1
`Evidenc e-2
`Evidence-3
`Evidence-4
`
`Original PDF file:
`http://tgate/PDF/POA/2008/06/10/20080610151126796925-77049554-009_005/evi_2167671-
`150348571_._ex_d.PDF
`'
`Converted PDF file(s) (3 pages)
`Evidence- 1
`Evidence-2
`Evidence-3
`
`Original PDF file:
`http://tgate/PDF/POA/2008/06/10/2008061015 1126796925-77049554-009_006/evi_2167671-
`150348571_.__ex_e. PDF
`Converted PDF file(s) (7 pages)
`Evidence- 1
`Evidence-2
`Evidence-3
`Evidence-4
`Evidence-5
`Evidence-6
`Evidence-7
`
`Original PDF file:
`http://tgate/PDF/POA/2008/06/10/200806101 5 1126796925-77049554-009_OO7/evi_2167671-
`l50348571_._ex_f.PDF
`Converted PDF fle(s) (5 pages)
`Evidenc e- 1
`Evidence-2
`Evidence-3
`
`f11e://\\ticrs- ais-01\ticrsexp0rt\HtmlToTifiInput\POA000 12008_06_13_12_0 1_3 0_TTABO...
`
`6/13/2008
`
`

`
`Petition To Revive For Office Action
`
`Page 8 of 9
`
`Evidence-4
`Evidence-5
`
`Original PDF file:
`http://tgate/PDF/POA/2008/06/10/2008061015 1126796925-770495 54-009_008/evi_2167671-
`150348571_._ex_g.PDF
`Converted PDF l'1le(s) (3 pages)
`Evidence-1
`Evidence-2
`Evidence-3
`
`Original PDF file:
`http://tgate/PDF/POA/2008/06/10/20080610151126796925-77049554-009_O09/evi_2l67671-
`l50348571_._ex_h.PDF
`Converted PDF file(s) (4 pages)
`Evidence—1
`
`FaIi<iencL-2
`Evidence-3
`Evidence-4
`
`CLASSIFICATION AND LISTING OF GOODS/SERVICES
`
`Applicant proposes to amend the following class of goods/services in the application:
`'
`Current: Class 010 for ORALLY OR RECTALLY ADMINISTERED SUPPOSITORIES,
`SUSPENSIONS, GELS, FAST MELT TABLETS, ORALLY DISINTEGRATING TABLETS AND
`ORALLY DISINTEGRATING WAFERS CONTAINING A MUCOSAL BARRIER PREPARATION
`
`FOR THE TREATMENT OF ULCERATIVE CONDITIONS OF THE OROPHARYNGEAL,
`ESOPHAGEAL, RECTUM OR-GASTROINTESTINAL TRACT; VAGINALLY OR
`GENITOURINARY ADMINISTERED CREAMS, OINTMENTS, LOTIONS, GELS, INSERTS AND
`SUPPOSITORIES CONTAINING PHARMACEUTICAL PREPARATIONS FOR THE TREATMENT
`
`OF VAGINAL OR GENITOURINARY TRACT DISEASES; MEDICAL DEVICES, NAMELY,
`SUPPOSITORIES, SUSPENSIONS, GELS, FAST MELT TABLETS, ORALLY DISINTEGRATING
`TABLETS, ORALLY DISINTEGRATING WAFERS, CREAMS, OINTMENTS, LOTIONS, GELS,
`OR INSERTS FOR DISAGNOSING OR TREATING DISEASES OF THE ORAL CAVITY,
`TONGUE, THROAT, PHARYNX, NASAL PASSAGES, SINUSES, ESOPHAGUS, STOMACH,
`INTESTINAL TRACT, OR RECTUM
`
`Original Filing Basis:
`Filing Basis: Section 1(b), Intent to Use: The applicant has a bona fide intention to use or use through
`the applicant's related company or licensee the mark in commerce on or in connection with the identified
`goods and/or services as of the filing date of the application. (15 U.S.C. Section 1051(b)).
`
`Proposed: Class 010 for ORALLY OR RECTALLY ADMINISTERED SUPPOSITORIES,
`SUSPENSIONS, GELS, FAST MELT TABLETS, ORALLY DISINTEGRATING TABLETS AND
`ORALLY DISINTEGRATING WAFERS CONTAINING A MUCOSAL BARRIER PREPARATION
`
`FOR THE TREATMENT OF ULCERATIVE CONDITIONS OF THE OROPHARYNGEAL,
`ESOPHAGEAL, RECTUM OR GASTROINTESTINAL TRACT; VAGINALLY OR
`GENITOURINARY ADMINISTERED CREAMS, OINTMENTS, LOTIONS, GELS, INSERTS AND
`SUPPOSITORIES CONTAINING PHARMACEUTICAL PREPARATIONS FOR THE TREATMENT
`
`OF VAGINAL OR GENITOURINARY TRACT DISEASES; MEDICAL DEVICES, NAMELY,
`SUPPOSITORIES, SUSPENSIONS, GELS, FAST MELT TABLETS, ORALLY DISINTEGRATING
`TABLETS, ORALLY DISINTEGRATING WAFERS, CREAMS, OINTMENTS, LOTIONS, GELS,
`OR INSERTS FOR DIAGNOSING OR TREATING DISEASES OF THE ORAL CAVITY, TONGUE,
`THROAT, PHARYNX, NASAL PASSAGES, SINUSES, ESOPHAGUS, STOMACH, INTESTINAL
`TRACT, OR RECTUM
`
`file://\\ticrs-ais—O 1.\ticrsexport\HtmlToTiflInput\POA000 12008_06_13_12__0l__30_TTABO...
`
`6/ 1 3/2008
`
`

`
`Petition To Revive For Office Action
`
`Page 9 of 9
`
`Filing Basis: Section 1(b), Intent to Use: The applicant has a bona fide intention to use or use through
`the applicant's related company or licensee the mark in commerce on or in connection with the identified
`goods and/or services as of the filing date of the application. (15 U.S.C. Section 105 1(b)).
`
`FEE(S)
`Fee(s) in the amount of $100 is being submitted.
`
`SIGNATURE(S)
`Declaration Signature
`Ihereby elect to bypass the submission of a signed declaration, because I believe a declaration is not
`required by the rules of practice. I understand that the examining attorney could still, upon later review,
`require a signed declaration.
`Petition/Response Signature
`Signature: /pjh/ Date: 06/10/2008
`Signatory/'s Name: Peter J. Hardin
`Signatory's Position: Attorney of Record
`
`The signatory has confirmed that he/she is an attorney who is a member in good standing of the bar of
`the highest court of a U.S. state, which includes the District of Columbia, Puerto Rico, and other federal
`territories and possessions; and he/she is currently the applicant's attorney or an associate thereof; and to
`the best of his/her knowledge, if prior to his/her appointment another U.S. attorney or a Canadian
`attomey/agent not currently associated with his/her company/firm previously represented the applicant
`in this matter: (1) the applicant has filed or is concurrently filing a signed revocation of or substitute
`power of attorney with the USPTO; (2) the USPTO has granted the request of the prior representative to
`Withdraw; (3) the applicant has filed a power of attorney appointing him/her in this matter; or (4) the
`applicant's appointed U.S. attorney or Canadian attorney/agent has filed a power of attorney appointing
`him/her as an associate attorney in this matter.
`
`RAM Sale Number: 471
`
`RAM Accounting Date: 06/11/2008
`
`Serial Number: 77049554
`
`Internet Transmission Date: Tue Jun 10 15:11:26 EDT 2008
`
`TEAS Stamp: USPTO/POA-216.76.7. 1-20080610151 12679692
`5-770495 54-4208fcc949f85b6524ecea07f1e5b
`807c9d-DA-471-200806101503485715 87
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`file://\\ticrs-ais-01\ticrsexport\HtmlToTiffInput\POA00012008_06_13_12_01_30_TTABO...
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`6/13/2008
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`In re: Application of
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`Centrix Pharmaceutical, Inc.
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`For:
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`CENTRJX
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`Serial No. 77/049,554
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`Filed: November 22, 2006
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`~.4\/s/\/\./\/»,,:\4\4
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`Trademark Law Office: 103
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`Examining Attorney: Mark Sparacino
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`Commissioner for Trademarks
`P.O. Box 1451
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`Alexandria, VA 22313-1451
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`Dear Sir:
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`ANEENDMENT
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`This is in response to the Office action mailed November 13, 2007.
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`The trademark attorney has refused registration of applicant’s mark (i) on the basis that
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`the proposed amendment to the identification of goods cannot be accepted because it refers to
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`goods that are not within the scope of the identification that was set forth in the application at the
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`time of the filing, and (ii) under Trademark Act Section 2(d) on the grounds that there is a
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`likelihood of confiision between applicant’s mark CENTRIX and Registration No. 3,266,168
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`(“the ‘ 168 registration”) for the trademark HEARTCENTRD( for “computer software and
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`middleware containing a database and viewer which stores the data and results from medical
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`diagnostic tests and which facilitates physician review and editing of the test results.”
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`Applicant respectfully requests that the trademark attorney reconsider and withdraw the
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`refusal of app1icant’s proposed amendment to the identification of goods for the reasons set forth
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`hereafter as well as the citation to the ‘I68 registration on the grounds that there is no likelihood
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`of confusion between applicant’s mark and the cited mark for the reasons set forth hereafter.
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`

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`77/049,554
`Law Office 103
`Mark Sparacino
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`Refusal to Accept Applicant’s Proposed Amendment
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`The trademark attorney apparently interpreted applicant’s proposed amendment of goods
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`for “orally or rectally administered suppositories, suspensions, gels, fast melt tablets, orally
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`disintegrating tablets and orally disintegrating wafers containing a mucosal barrier preparation
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`for the treatment of ulcerative conditions of the oropharyngeal, esophageal, rectum or
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`gastrointestinal tract; vaginally or genitourinary administered creams, ointments, lotions, gels,
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`inserts and suppositories containing pharmaceutical preparations for the treatment of vaginal or
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`genitourinary tract diseases; medical devices, namely, suppositories, suspensions, gels, fast melt
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`tablets, orally disintegrating tablets, orally disintegrating wafers, creams, ointments, lotions, gels,
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`or inserts for diagnosing or treating diseases of the oral cavity, tongue, throat, pharynx,.nasa1
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`passages, sinuses, esophagus, stomach, intestinal tract, or rectum” as attempting to add to or
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`broaden the scope of applicant’s initial description of goods as “medical devices” by including in
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`said amendment goods that are only susceptible of being classified as drugs or drug related
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`goods. This position is not supported by interpretations of the United States Food and Drug
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`Administration (the “FDA”), the primary federal regulatory agency tasked with the interpretation
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`and enforcement of federal laws regulating both medical devices and drugs, which is also the
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`agency consulted by the trademark attorney for the definition of a medical device.
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`The trademark attorney properly referenced Section 20l(h) of the Federal Food, Drug &
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`Cosmetic (“FD&C”) Act for the accepted definition of a medical “device” under United States
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`law. Section 20l(h) of the FD&C Act provides that the “term ‘device’ . . . means an instrument,
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`apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related
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`article, including any component, part, or accessory, which is-
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`77l049,554
`Law Office 103
`Mark Sparacino
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`(I) recognized in the official National Formulary,ior the United States Pharmacopeia, or
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`any supplement to them,
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`(2) intended for use in the diagnosis of disease or other conditions, or in the cure,
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`mitigation, treatment, or prevention of disease, in man or other animals, or
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`(3) intended to affect the structure or any fimction of the body of man or other animals,
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`and which does not achieve its primary intended purposes through chemical action within or
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`on the body of man or other animals and which is not dependent upon being metabolized for the
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`achievement ofits primag intended pur_'poses.”
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`§§§ Section 2Ol{l_1) ofthe FD&C Act (emphasis added) attached hereto as Exhibit A
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`This is the definition relied upon by the FDA in determining which products are
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`considered a medical device, and hence subject to regulation by the FDA’s Center for Devices
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`and Radiological Health (“CDRH”), and which products are considered a drug, and hence
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`subject to regulation by the FDA’s Center for Drug Evaluation and Research (“CDER”).
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`In
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`essence, the FDA has concluded that if the primary intended use of the product is achieved
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`through chemical action or by being metabolized by the body, the product is usually considered
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`to be a drug and subject to regulation by the CDER. This means that the form of a product itself,
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`such as it being a gel, pill, wafer or some other physical shape. or form, is not the factor that is
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`used in determining whether a product is classified as either a drug or a medical device under
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`United States law; instead, it is the primary intended use of a product that is the relevant factor in
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`determining whether a product is considered to‘ be a medical device.
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`Just because a product
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`resembles a drug in taking the shape of “orally or rectally administered suppositories,
`-suspensions, gels, fast melt tablets, orally disintegrating tablets and orally disintegrating wafers” .
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`as proposed in part by applicant for its amended description goods for example, does not mean
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`Mark Sparacino
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`that the FDA would necessarily classify such a product as a drug if the primary intended use of
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`that product is not achieved through chemical action or by being metabolized by the body.
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`Instead, the FDA would likely ‘classify such a product as a medical device. This classification of
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`a product by the FDA’ as either a medical device or a drug should also govern the classification
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`such product for United States trademark law. After all, if both the applicant and the FDA were
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`to consider a particular product as a medical device but protection for the mark associated with
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`such product were obtained for federal trademark law on some basis other than as a medical
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`device, such as the product being classified as a drug, applicant’s mark could be subject to
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`challenge as being misclassified and applicant could be deemed to not have any protection for its
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`mark for the principal use of its associated product.
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`Applicant seeks to register its proposed mark in International Class 10 as a medical
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`device because that is the classification that will likely be given applicant’s products by the FDA
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`applying the analysis set forth above. The FD&C Act provides two main regulatory pathways to
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`permit a device that is not otherwise deemed to be exempt from regulation by the FDA to be
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`classified as a medical device which is permitted to be sold in the United States. These two main
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`pathways are (i) Section 510(k) of the FD&C Act, or premarket submission, whereby a
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`manufacturer of a product obtains an order, in the form of a letter, from FDA which finds the
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`device to be substantially equivalent, that is at least as safe and effective, to another legally
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`marketed medical device, or (ii) Section 515 of the FD&C Act, or premarket approval, whereby
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`a manufacturer of a product is required to submit a more stringent type of device marketing
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`application to allow the FDA to conduct a scientific and regulatory review of the safety and
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`effectiveness of such medical device. S_ee Center for Devices and Radiological Health, §e_tti_ng
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`To
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`Market
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`With
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`A
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`Medical
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`Device,
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`(last.
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`updated
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`6/10/2003)
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`http://www.fda.gov/cdrh/devadvice/3122.html#link_2, a copy of which is attached hereto as
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`Exhibit B Once a manufacturer has received a 510(k) approval letter for a product, it is free to
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`market such product as a medical device in the United States. E Center for Devices and
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`Radiological Health, Premarket Notification 510(l_c),
`(last updated November 1,2006)
`http.'//wwvvfda.gov/cdrh/devadvice/314.html, a copy of which is attached hereto as Exhibit C.
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`The FDA has issued many 510(k) approval letters for products that also have a chemical
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`composition or a component part that resembles a product that could also be considered a drug
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`under different circumstances but for which its primary intended purposes is not achieved
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`through chemical action or by being metabolized by the body. For example, the CDRH has
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`approved the topical ointment compound Bismuth Subgallate/Borneol, also known as “Siule”, as
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`a medical device and not as a drug, even though it is comprised of two chemical ingredients,
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`borneol and bismuth subgallate, in a petrolatum base, presumably because its primary intended
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`purpose is that of a wound dressing. E 510115) Approval Letter for Siule Ointment Wound
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`Dressing, dated July 7, 2004, attached hereto as Exhibit D; See also Thomas Serena, MD,
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`FACS, et. al., Bismuth Subgallate/Bomeol (Suile) Is Superior to Bacitracin in the Human
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`Forearm Biopsy Model for Acute Wound Healing, 485 Advances in Skin & Wound Care
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`(September 2007), a copy of which is attached hereto as Exhibit E (wherein the authors present
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`the results of their studies of Suile and reiterate that “Suile ointment is a topical medical device,
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`not a drug.,”).
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`In another example, the CDRH has approved the semi-viscous emulsion/cream
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`formulation Locobase Wound and Skin Emulsion that is intended for topical application as a
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`medical device and not as a drug, even though it is comprised of various chemical compounds,
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`because its primary intended purpose is that of a protective barrier. §e_e 510(l_<) Approval Letter
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`for Locobase Wound and Skin Emulsiop, dated January‘ 12, 2007, attached hereto as Exl*1ibitF.
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`In yet another example, the CDRH has approved Relief ACP Oral Care Gel, a chemical gel that
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`is applied to the teeth to provide relief of discomfort from dentin sensitivity, as a medical device
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`and not as a drug.
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`_S_e_:§ 510(l_<_) Approval Letter for Relief ACP Oral Care Gel, dated January 10,
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`2007, attached hereto as Exhibit G.
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`Similarly, the applicant has filed its application for International Class 10 for medical
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`devices because the goods to be marketed by applicant are sought to be classified by the FDA as
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`medical devices. Applicant attempted to further limit its identification of goods within the class
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`of medical devices by filing its proposed amendment of goods to include only
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`[1] orally or rectally administered suppositories, suspensions, gels, fast melt tablets, orally
`disintegrating tablets and orally disintegrating wafers containing a mucosal barrier
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`preparation for the treatment of ulcerative conditions of the oropharyngeal, esophageal, rectum
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`or gastrointestinal tract;
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`[2] vaginally or genitourinary administered creams, ointments, lotions, gels, inserts and
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`suppositories containing pharmaceutical preparations for
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`the treatment" of vaginal or
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`genitourinary tract diseases; and
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` [3] medical devices namely, suppositories, suspensions, gels, fast melt tablets, orally
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`disintegrating tablets, orally disintegrating wafers, creams, ointments, lotions, gels, or inserts f9_t_'
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`diagnosing or treating diseases of the oral cavity,
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`tongue,» throat, pharynx, nasal passages,
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`sinuses, esophagus, stomach, intestinal tract, or rectum.
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`§e_;e_ Applicant’s Original Proposed Amendment to Identification of Goods (emphasis
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`added).
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`The first product description is limited to medical devices that act as a mucosal barrier.
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`The second product description is limited to medical devices acting as a drug delivery
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`mechanism in delivering pharmaceutical preparations, and not as the pharmaceutical preparation
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`itself. The third product is limited to medical devices acting, as a medical device for diagnosing
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`or treating diseases.
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`In the case of any product sought to be marketed by the applicant as a
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`medical device that would fall within any of the above descriptions, the FDA will scrutinize such
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`products for compliance with the definition of a medical device, and applicant’s protection for its
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`proposed mark will necessarily be limited to those products classified by the FDA as medical
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`devices, which are properly classified within International Class 10. Therefore, since applicanfis
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`proposed amendment does clarify or limit the goods for which trademark protection was
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`originally sought, applicant’s proposed ‘amendment should be acceptable and not subject to
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`refusal as an attempted expansion of the original product description. For this reason, the
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`applicant respectfully requests that
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`the trademark attorney withdraw its refusal to accept
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`applicant’s proposed amendment.
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`Section 2(d) Refusal
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`The trademark attorney has refused registration of applicant’s mark under Trademark Act
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`Section 2(d) on the grounds that there is a likelihood of confusion between applicant’s mark
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`CENTRIX for medical devices as limited above and the ‘I68 registration for the trademark
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`HEARTCENTRIX for “computer software and middleware containing -a database and viewer
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`which stores, the data and results fiom medical diagnostic tests and which facilitates physician
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`review and editing of the test results.”
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`The test for determining the applicability of § 2(d) ofthe Trademark Act is whether an
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`appreciable numb'er of ordinarily prudent purchasers are likely to be misled or confused as to the
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`source of the products or services. McGregor—Doniger, Inc., v. Drizzle, Inc.,- 202 USPQ 81 (2“d
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`Cir. 1979) (holding no likelihood of confusion between DRIZZLE for women’s overcoats and
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`DRIZZLER for golfjackets). In considering the issue of likelihood OfCOI1fi1SiO1'l, the trademarks
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`must be compared in their entireties and must be considered in conjunction with the particular
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`goods with which they are used.
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`In re National Data Com, 753 F.2d 1056, 1058 (Fed. Cir.
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`1985). The use of identical, even dominant, words in common does not automatically mean that
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`two marks are similar. Freedom Saving & Loan Assoc. v. Way, 757 F. 2d 1176, 1183 (1 1”’ Cir.
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`1985). Further, the Trademark Office must take into consideration the scope of protection to be
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`accorded the marks.
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`While the parties’ respective marks include the term “centrix,” there .-are differences
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`between them that obviate any likelihood ofconfusion. Specifically, applicant’s mark is the two-
`syllable, one-word term CENTRIX. The ‘l68 registration is for the three-syllable word
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`HEARTCENTRlX.
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`The parties respective trademarks,
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`therefore,
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`sound different,
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`i.e.,
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`CENTRIX, two syllables, versus HEARTCENTRIX, three syllables; and appear vastly different,
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`CENTRIX, one short word vs. HEARTCBNTRDC, one long. word. They create different
`commercial impressions.
`S_ec:_ Safeway Stores, Inc. v.» Bel. Canto Fancy Foods Ltd., 5 USPQ 2d.
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`1980 (TTAB 1987) (holding BEL ARIA for sauces, spreads and dried tomatoes and BEL-ARIA
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`for fiozen foods and frozen concentrated orange juice product somewhat similar in appearance,
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`only slightly similar in sound or pronunciation, and essentially dissimilar in tenns of meaning‘
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`and connotation).
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`These differences when taken together, are ‘sufficient
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`to preclude a likelihood of
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`confusion.
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`§§e_ EZ Loader Boat Trailers, Inc. v. Cox Trailers, Inc., 706 F.2d 1213 (Fed. Cir.
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`1983) (finding SUPERLOADER not confusingly similar to EZ LOADER or MINT LOADER for
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`boat trailers). “[T]he mere fact that the marks» in issue share elements, even dominant elements,
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`Mark Sparacino
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`does not compel a conclusion of likelihood of confusion.”
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`824 F.2d 622, 627 (l 1"‘ Cir. 1985). Thus, the Trademark Trial and Appeal Board and the courts
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`have held in a number of cases that even though trademarks may be similar 153$ in sound
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`and appearance, where the goods/services are different, the channels of trade are different or the
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`purchasers of the goods/services are sophisticated, there will be no likelihood of confusion. Sge
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`gg, Astra Pharmaceutical Products Inc. v. Beckman Instruments Inc. 220 USPQ 786 (la Cir.
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`1983) (holding no likelihood of confusion between the trademark ASTRA for computerized
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`blood analyzer machine and other products related to the machine and ASTRA for
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`pharmaceutical preparations and syringes); Information Resources Inc. v. X"‘Press Information
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`Services 6 USPQ 1034 (TTAB 19