throbber
UNITED STATES PATENT AND TRADEMARK OFFICE
`
`~TEDSTATESDEPARTMENTOFCO~RCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexm!dria, VIrginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`13/277,789
`
`10/20/2011
`
`Robert A. Ashley
`
`512-53 DIV/CON II
`
`4179
`
`05/14/2012
`7590
`23869
`HOFFMANN & BARON, LLP
`6900 JERICHO TURNPIKE
`SYOSSET, NY 11791
`
`EXAMINER
`
`TRAN, SUSAN T
`
`ARTUNIT
`
`1615
`
`MAIL DATE
`
`05/14/2012
`
`PAPERNUMBER
`
`DELIVERY MODE
`
`PAPER
`
`Please fmd below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL-90A (Rev. 04/07)
`
`Dr. Reddy's Laboratories, Ltd., et al.
`v.
`Galderma Laboratories, Inc.
`IPR2015-__
`Exhibit 1069
`
`Exh. 1069, Page 1 of 17
`
`

`
`Application No.
`
`13/277,789
`
`Applicant(s)
`
`ASHLEY, ROBERT A.
`
`Office Action Summary
`
`Art Unit
`Examiner
`1615
`SUSAN TRAN
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;2 MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR t. t 36(a). In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § t33).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR t .704(b).
`Status
`1 )0 Responsive to communication(s) filed on __ .
`2b)[8] This action is non-final.
`2a)0 This action is FINAL.
`3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on
`__ ;the restriction requirement and election have been incorporated into this action.
`4)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 C. D. 11, 453 O.G. 213.
`Disposition of Claims
`5)[8] Claim(s) 21-40 is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)[8] Claim(s) 21-40 is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)0 Claim(s) __ are subject to restriction and/or election requirement.
`
`Application Papers
`1 0)0 The specification is objected to by the Examiner.
`11 )0 The drawing(s) filed on __ is/are: a)O accepted or b)O objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`12)0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PT0-152.
`Priority under 35 U.S.C. § 119
`13)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)O All b)O Some * c)O None of:
`1.0 Certified copies of the priority documents have been received.
`2.0 Certified copies of the priority documents have been received in Application No. __ .
`3.0 Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`*See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment{s)
`1) [8] Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) [8] Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 02/01112.
`U.S. Patent and Trademark Off1ce
`PTOL-326 (Rev. 03·11)
`
`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20120507
`
`Exh. 1069, Page 2 of 17
`
`

`
`Application/Control Number: 13/277,789
`Art Unit: 1615
`
`Page 2
`
`DETAILED ACTION
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 1 03(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 1 02 of this title, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
`
`Claims 21, 23, 25-28, 30, 32-35 and 38-40 are rejected under 35 U.S. C. 103(a)
`
`as being unpatentable over Perricone US 6,365,623, in view of Pflugfelder eta/.
`us 6,455,583.
`Perricone teaches a method for the treatment of pustule and papule. The
`
`method comprises orally administering an antibiotic compound. See column 5, lines 40-
`
`45; column 6, lines 20-24; and column 8, lines 24-29.
`
`Perricone does not expressly teach the claimed amount of antibiotic compound,
`
`as well as the claimed antibiotic such as doxycycline.
`
`Pflugfelder teaches a method for treating conditions associated with rosacea.
`
`The method comprises orally administering a tetracycline compound in a sub-
`
`antimicrobial amount that ranges from about 20% to about 80% of the normal antibiotic
`
`therapeutic dose of the particular tetracycline compound. See abstract; column 4, lines
`
`1-1 0; and column 5, lines 1-12. Tetracycline compound includes doxycycline is found in
`
`column 6, line 5; and claim 3.
`
`Thus, it would have been obvious to one of ordinary skill in the art at the time the
`
`invention was made to optimize the method of Perricone to administer antibiotic
`
`Exh. 1069, Page 3 of 17
`
`

`
`Application/Control Number: 13/277,789
`Art Unit: 1615
`
`Page 3
`
`compound in a sub-antimicrobial amount in view of the teachings of Pflugfelder. This is
`
`because: 1) Pflugfelder teaches the use of an antibiotic compound for the treatment of
`
`rosacea related conditions is known in the art; 2) Pflugfelder teaches that long term
`
`administration of antibiotic compound in a sub-antimicrobial amount will minimized
`
`tetracycline advert side-effects such as nausea, vomiting, diarrhea, and epigastric pain
`
`(column 1, lines 48-63); and 3) Perricone teaches the desirability for administering
`
`antibiotic compound in a lower dosage amount to eliminate advert side-effect such as
`
`nausea, Gl upset, yeast infection, and interactions with other medication (column 8,
`
`lines 30-40).
`
`Claims 24, 25, 31, 32, 37 and 38 are rejected under 35 U.S. C. 103(a) as being
`
`unpatentable over Perricone US 6,365,623, in view of Pflugfelder eta/. US
`
`6,455,583 and Sheth et a/. US 5,300,304.
`
`Perricone is relied upon for the reasons stated above. The reference is silent
`
`with respect to the once-a-day sustained release dosage.
`
`Sheth teaches a pulsatile once-a-day dosage form of a non-toxic acid
`
`tetracycline compound for the treatment of acne. See abstract; columns 5-6; and
`
`claims.
`
`Thus, it would have been obvious to one of ordinary skill in the art at the time the
`
`invention was made to optimize the composition of Perricone to include a once-a-day
`
`antibiotic composition because Sheth teaches an antibiotic once-a-day dosage form is
`
`known in the art.
`
`Exh. 1069, Page 4 of 17
`
`

`
`Application/Control Number: 13/277,789
`Art Unit: 1615
`
`Page 4
`
`Claims 22, 29 and 36 are rejected under 35 U.S. C. 103(a) as being
`
`unpatentable over Perricone US 6,365,623, in view of Pflugfelder eta/. US
`
`6,455,583 and Heesch US 200210165220 A1.
`
`Perricone is relied upon for the reasons stated above. Perricone does not teach
`
`the hyclate salt of doxycycline.
`
`Heesch teaches a tetracycline compound useful for the treatment of acne
`
`includes doxycycline. Heesch further teaches that doxycycline hyclate exhibits better
`
`advantage over the doxyclycline compound. See abstract; paragraphs 0093-0094 and
`
`claims.
`
`Thus, it would have been obvious to one of ordinary skill in the art at the time the
`
`invention was made to optimize the composition of Perricone to include the hyclate salt
`
`of the antibiotic compound in view of the teachings of Heesch. This is because
`
`doxycycline monohydrate (hyclate) provides lover dosage requirement, and because
`
`Perricone teaches the desirability for lover antibiotic dosage.
`
`Correspondence
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to SUSAN TRAN whose telephone number is (571 )272-
`
`0606. The examiner can normally be reached on M-F 8:30am to 5:30 pm.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number
`
`for the organization where this application or proceeding is assigned is 571 -273-8300.
`
`Exh. 1069, Page 5 of 17
`
`

`
`Application/Control Number: 13/277,789
`Art Unit: 1615
`
`Page 5
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR system, contact the Electronic
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`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
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`USPTO Customer Service Representative or access to the automated information
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`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`IS. TRANI
`Primary Examiner, Art Unit 1615
`
`Exh. 1069, Page 6 of 17
`
`

`
`Notice of References Cited
`
`Document Number
`Country Code-Number-Kind Code
`
`Application/Control No.
`
`13/277,789
`
`Examiner
`SUSAN TRAN
`U.S. PATENT DOCUMENTS
`
`Name
`
`Sheth et al.
`Perricone, Nicholas V.
`Pflugfelder et al.
`Heesch, Gary V.
`
`Applicant(s)/Patent Under
`Reexamination
`ASHLEY, ROBERT A.
`Art Unit
`1615
`
`Page 1 of 1
`
`Classification
`
`424/490
`514/448
`514/528
`514/210.09
`
`Date
`MM-YYYY
`04-1994
`04-2002
`09-2002
`11-2002
`
`A
`
`*
`*
`*
`*
`*
`
`US-5,300,304
`US-6,365,623
`B
`c US-6,455,583
`D US-2002/0165220
`US-
`E
`US-
`US-
`US-
`US-
`US-
`US-
`US-
`L
`M US-
`
`F
`
`G
`
`H
`I
`J
`
`K
`
`*
`
`Document Number
`Country Code-Number-Kind Code
`
`Date
`MM-YYYY
`
`Country
`
`Name
`
`Classification
`
`FOREIGN PATENT DOCUMENTS
`
`NON-PATENT DOCUMENTS
`Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages)
`
`*
`
`N
`0
`p
`
`Q
`
`R
`s
`T
`
`u
`
`v
`
`w
`
`X
`
`* A copy of th1s reference 1s not bemg furnished w1th th1s Off1ce act1on. (See MPEP § 707.05(a).)
`Dates in MM-YYYY format are publication dates. Classifications may be US or foreign.
`
`U.S. Patent and Trademark Office
`PT0-892 (Rev. 01-2001)
`
`Notice of References Cited
`
`Part of Paper No. 20120507
`
`Exh. 1069, Page 7 of 17
`
`

`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /S.T./
`
`PTO/SB/08a (01-10)
`Doc code: IDS
`Approved for use through 07/31/2012. OMB 0651-0031
`Doc description: Information Disclosure Statement (IDS) Filed
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`IN FORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`Filing Date
`First Named Inventor
`Art Unit
`Examiner Name
`I
`Attorney Docket Number
`
`13277789
`2011-10-20
`
`I Robert Ashley
`
`512-53 DIV/CON II
`
`Examiner Cite
`Initial*
`No
`
`Patent Number
`
`Kind
`Code1 Issue Date
`
`Name of Patentee or Applicant Pages,Columns,Lines where
`Relevant Passages or Relevant
`of cited Document
`Figures Appear
`
`U.S.PATENTS
`
`Remove
`
`1
`
`5998390
`
`1999-12-07
`
`Ramamurthy et al.
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`5908838
`
`1999-06-01
`
`Gans
`
`5827840
`
`2008-10-27
`
`Ramamurthy et al.
`
`5122519
`
`1992-06-16
`
`Ritter
`
`5674539
`
`1997-10-07
`
`Tomas et al.
`
`6673843
`
`2004-01-06
`
`Arbiser
`
`4704383
`
`1987-11-03
`
`McNamara, et al.
`
`7014858
`
`2006-03-21
`
`Robert A. Ashley
`
`EFS Web 2.1.17
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /S.T./
`
`Exh. 1069, Page 8 of 17
`
`

`
`IN FORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`ALL REFERENCES CONSIDER .Aipp)l8c!itF6Tn\Md~rLINED THF , (il:00Jrtl89'. T .I
`Filing Date
`2011-10-20
`First Named Inventor
`I Robert Ashley
`Art Unit
`Examiner Name
`I
`Attorney Docket Number
`
`512-53 DIV/CON II
`
`9
`
`6455583
`
`2007-09-24
`
`Pflugfelder et al.
`
`10
`
`5260292
`
`1993-11-09
`
`Robinson et al.
`
`11
`
`5532227
`
`1996-07-02
`
`Golub et al.
`
`12
`
`5045538
`
`1991-09-03
`
`Schneider et al.
`
`13
`
`6294200
`
`2001-09-25
`
`Conte et al.
`
`If you wish to add additional U.S. Patent citation information please click the Add button.
`U.S.PATENT APPLICATION PUBLICATIONS
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`Add
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`
`Examiner
`Initial*
`
`Publication
`Cite No Number
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`Kind Publication
`Code1 Date
`
`Name of Patentee or Applicant Pages,Columns,Lines where
`Relevant Passages or Relevant
`of cited Document
`Figures Appear
`
`1
`
`2
`
`3
`
`20030082120
`
`2003-05-01
`
`Milstein
`
`20030148945
`
`2003-08-07
`
`McNicol et al.
`
`20050239723
`
`2005-10-27
`
`Amin et al.
`
`If you wish to add additional U.S. Published Application citation information please click the Add button. Add
`Remove
`FOREIGN PATENT DOCUMENTS
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /S.T./
`
`EFS Web 2.1.17
`
`Exh. 1069, Page 9 of 17
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`

`
`IN FORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`ALL REFERENCES CONSIDERED EX Qqf~liM'iM~fi\~i:.I-Ni& TH ROUG: ~d§!ifi89
`2011-10-20
`Filing Date
`First Named Inventor
`Art Unit
`Examiner Name
`I
`Attorney Docket Number
`
`I Robert Ashley
`
`512-53 DIV/CON II
`
`Examiner Cite Foreign Document
`No Number3
`Initial*
`
`Country
`Code2 i
`
`Name of Patentee or
`Kind Publication Applicant of cited
`Code4 Date
`Document
`
`Pages,Columns,Lines
`where Relevant
`Passages or Relevant
`Figures Appear
`
`T5
`
`1
`
`EP 0 410 099
`
`EP
`
`A1
`
`1991-01-30
`
`2
`
`3
`
`wo 83/00628
`
`wo
`
`1983-03-03
`
`wo 99/58131
`
`wo
`
`1999-11-18
`
`4
`
`wo 00/028983
`
`wo
`
`2000-05-25
`
`5
`
`6
`
`wo 00/15235
`
`wo
`
`2000-03-23
`
`wo 00/18230
`
`wo
`
`2011-04-06
`
`7
`
`JP-A-2001-72660
`
`JP
`
`2001-03-21
`
`8
`
`JP-A-5-509288
`
`JP
`
`1993-12-22
`
`9
`
`wo 00/07601
`
`wo
`
`2001-02-17
`
`10 wo 98/08480
`
`wo
`
`1998-03-05
`
`D
`
`D
`
`D
`
`D
`
`D
`
`D
`
`[8]
`
`[8]
`
`D
`
`D
`
`abstract
`
`abstract
`
`EFS Web 2.1.17
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`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /S.T./
`
`Exh. 1069, Page 10 of 17
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`

`
`ALL Rt:Ft:RENCES CONSIDeRED t ~Riia~rij~rh~D THROU pn2fii89
`2011-10-20
`Filing Date
`
`IN FORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`First Named Inventor
`
`I Robert Ashley
`
`Art Unit
`
`Examiner Name
`
`I
`Attorney Docket Number
`
`512-53 DIV/CON II
`
`11 wo 92/03133
`
`wo
`
`1992-03-05
`
`12 wo 98/05340
`
`wo
`
`1998-02-12
`
`13
`
`JP-A-91-88617
`
`JP
`
`1997-07-22
`
`abstract
`
`D
`
`D
`
`[8]
`
`If you wish to add additional Foreign Patent Document citation information please click the Add button
`
`NON-PATENT LITERATURE DOCUMENTS
`
`Add
`
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`
`Examiner Cite
`Initials* No
`
`Include name of the author (in CAPITAL LETTERS}, title of the article (when appropriate}, title of the item
`(book, magazine, journal, serial, symposium, catalog, etc}, date, pages(s), volume-issue number(s),
`publisher, city and/or country where published.
`
`T5
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`Akamatsu, et al. "Effect of Keigai-Rengyo-To, a Japanese Kampo Medicine, on Neutorphil Functions: a Possible
`Mechanism of Action of Keigai-Rengyo-To in Acne," The Journal of International Medical Research, 25: 255-265
`(1997).
`
`Baer, et al. "High-Dose Tetracycline Therapy in Severe Acne," Arch Dermatol, 112:479-481 (April1976).
`
`Cheryl Guttman, "Emerging resistance changes face of antibiotic therapy for acne," Dermatology Times, January
`2001, page 22.
`
`Hirohiko Akamatsu, Maki Asada, Jinro Komura, Yasuo Asada, and Yukie Niwa, "Effect of Doxycycline on the
`Generation of Reactive Oxygen Species: A Possible Mechanism of Action of Acne Therapy with Doxycycline," Acta
`Derm Venereol (Stockh) 72:178-178 (1992).
`
`Bodokh, Y. Jacomet, J. Ph. Lacour and J.P. Ortonne, "Minocycline Induces an Increase in the Number of Excreting
`Pilosebaceous Follicles in Acne Vulgaris," Acta Derm Venereol (Stockh), 77:255-259 (1997).
`
`W. J. Cunliffe, M.D., F.R.C.P., "Evolution of a Strategy for the Treatment of Acne," JAm Acad Dermatol, 16:591-9
`(1987).
`
`D
`
`D
`
`D
`
`D
`
`D
`
`D
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`EFS Web 2.1.17
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`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /S.T./
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`Exh. 1069, Page 11 of 17
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`

`
`13277789
`Application Number
`ALL REFERENCES CONSIDE F~~6~PeT WHERE LINED TH 00\JOHdS.T.!
`IN FORMATION DISCLOSURE
`First Named Inventor
`I Robert Ashley
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Art Unit
`
`Examiner Name
`
`I
`Attorney Docket Number
`
`512-53 DIV/CON II
`
`7
`
`8
`
`9
`
`E. Anne Eady, Eileen Ingham, Christina E. Walters, Jonathan H. Cove, and William J. Cunliffe, "Modulation of
`Comedonal Levels of lnterleukin-1 in Acne Patients Treated with Tetracyclines," J. Invest Dermatol, 101:86-91 {1993).
`
`D
`
`Boni E. Elewski, M.D., Beth A.J. Lamb, W. Mitchell Sams, Jr., M.D., and W. Ray Gammon, M.D., "In Vivo Suppression
`of Neutrophil Chemotaxis by Systemically and Topically Administered Tetracycline," JAm Acad Dermatol, 8:807-812 D
`(1983).
`
`Nancy B. Esterly, M.D., Nancy L. Furey, M.D., and Lillian E. Flanagan, B.S., 'The Effect of Antimicrobial Agents on
`Leukocyte Chemotaxis," The Journal of Investigative Dermatology, 70{1):51-55 {1978).
`
`D
`
`10
`
`Sainte-Marie, I. Tenaud, 0. Jumbou and B. Dreno, "Minocycline Modulation of Alpha-MSH Production by Keratinocytes D
`In vitro," Acta Derm Venereol79:265-267 {1999).
`
`11
`
`Hoshiki Miyachi, M.D., Akira Yoshioka, M.D., Sadao Imamura, M.D., and Yukie Niwa, M.D., "Effect of Antibiotics on the D
`Generation of Reactive Oxygen Species," J Invest Dermatol, 86(4):449-453 (1986).
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`G. F. Webster, K.J. McGinley, and J.J. Leyden, "Inhibition of Lipase Production in Propionibacterium acnes by Sub-
`Minimal-Inhibitory Concentrations of Tetracycline and Erythromycin," British Journal of Dermatology, 104:453-457
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`Granuloma Formation by Tetracyclines and Ciprofloxacin," Arch Dermatol., 130:748-752 (1994).
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`Reynold C. Wong, M.D., Sewon Kang, M.P.H., Jan L. Heezen, L.P.N., John J. Voorhees, M.D., and Charles N. Ellis,
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`

`
`ALL REFERENCES CONS!DE ~~OO~ifttJWPl~E UNED T ~U~~ iS.T./
`2011-10-20
`Filing Date
`
`IN FORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`First Named Inventor
`
`I Robert Ashley
`
`Art Unit
`
`Examiner Name
`
`I
`Attorney Docket Number
`
`512-53 DIV/CON II
`
`18
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`Subgingival Microflora in Refractory Adult Periodontitis," J. PeriodontaL, 53(10):604-610 (October 1982)_
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`drugs" Critical Reviews in Oral Biology and Medicine, 2(2):297-322 (1991)
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`
`Exh. 1069, Page 13 of 17
`
`

`
`IN FORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`ALL REFERENCES CONSI ~~Cf!~~FiERE LINE[ t~c~H. iS.T.i
`2011-10-20
`Filing Date
`First Named Inventor
`Art Unit
`Examiner Name
`I
`Attorney Docket Number
`
`I Robert Ashley
`
`512-53 DIV/CON II
`
`29
`
`Knight, et al. "A follow-up of tetracycline-treated rosacea" British Journal of Dermatology 93:577-580 (1975).
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`treatment of acne vulgaris" The British Journal of Clinical Practice 41{8):882-886 (August 1987)
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`Plewig, et al. Acne: Morphogenesis and Treatment, Springer-Verlag 297-301 (1975)
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`acnes by Subminimal Inhibitory Concentrations of Tetracycline, Ampicillin, Minocycline, and Erythromycin"
`Antimicrobial Agents and Chemotherapy 21{5):770-772 (1982)
`
`If you wish to add additional non-patent literature document citation information please click the Add button Add
`EXAMINER SIGNATURE
`
`D
`
`D
`
`Examiner Signature I
`
`/Susan T ran/
`05/07/2012
`I
`*EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through a
`citation if not in conformance and not considered. Include copy of this form with next communication to applicant.
`
`I Date Considered
`
`1 See Kind Codes of USPTO Patent Documents at www.USPTO.GOV or MPEP 901.04. z Enter office that issued the document, by the two-letter code (WI PO
`Standard ST.3). 3 For Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial number of the patent document
`4 Kind of document by the appropriate symbols as indicated on the document under WI PO Standard ST. 16 if possible_ 5 Applicant is to place a check mark here i
`English language translation is attached.
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`ALL REFERENCES CONSiDERED EXCEPT WHERE LINED THROUGH. /S.T./
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`EFS Web 2.1.17
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`Exh. 1069, Page 14 of 17
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`

`
`IN FORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`Filing Date
`First Named Inventor
`Art Unit
`Examiner Name
`I
`Attorney Docket Number
`
`13277789
`
`2011-10-20
`I Robert Ashley
`
`512-53 DIV/CON II
`
`Please see 37 CFR 1.97 and 1.98 to make the appropriate selection(s):
`
`CERTIFICATION STATEMENT
`
`D
`
`That each item of information contained in the information disclosure statement was first cited in any communication
`from a foreign patent office in a counterpart foreign application not more than three months prior to the filing of the
`information disclosure statement. See 37 CFR 1.97(e)(1).
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`OR
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`That no item of information contained in the information disclosure statement was cited in a communication from a
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`after making reasonable inquiry, no item of information contained in the information disclosure statement was known to
`D any individual designated in 37 CFR 1.56(c) more than three months prior to the filing of the information disclosure
`statement. See 37 CFR 1.97(e)(2).
`
`D See attached certification statement.
`D The fee set forth in 37 CFR 1.17 (p) has been submitted herewith.
`[8] A certification statement is not submitted herewith.
`
`SIGNATURE
`A signature of the applicant or representative is required in accordance with CFR 1.33, 1 0.18. Please see CFR 1.4(d) for the
`form of the signature.
`
`Signature
`Name/Print
`
`/susan a. sipos/
`Susan A. Sipos
`
`Date (YYYY-MM-DD)
`Registration Number
`
`2012-02-01
`43,128
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`
`EFS Web 2.1.17
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`Exh. 1069, Page 15 of 17
`
`

`
`Privacy Act Statement
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`The information on this form will be treated confidentially to the extent allowed under the Freedom of Information Act
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`A record related to an International Application filed under the Patent Cooperation Treaty in this system of records
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`A record from this system of records may be disclosed, as a routine use, to the public after either publication of
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`A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
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`EFS Web 2.1.17
`
`Exh. 1069, Page 16 of 17
`
`

`
`UNI1ED STATES PATENT AND TRADEMARK OFFICE
`
`Page 1 of 1
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`CONFIRMATION NO. 4179
`
`CLASS
`424
`
`GROUP ART UNIT ATTORNEY DOCKET
`NO.
`1615
`512-53 DIV/CON II
`
`BIB DATA SHEET
`
`SERIAL NUMBER
`13/277,789
`
`FILING or 371 (c)
`DATE
`10/20/2011
`RULE
`
`APPLICANTS
`Robert A. Ashley, Newtown, PA;
`** CONTINUING DATA *************************
`This application is a CON of 11/876,478 10/22/2007 PAT 8,052,983
`which is a CON of 10/757,656 01/14/2004 ABN
`which is a DIV of 10/117,709 04/05/2002 PAT 7,211,267
`which claims benefit of 60/325,489 09/26/2001
`and claims benefit of 60/281 ,916 04/05/2001
`** FOREIGN APPLICATIONS *************************
`** IF REQUIRED, FOREIGN FILING LICENSE GRANTED **
`11/28/2011
`DYes ~No
`Foreign Priority claimed
`35 USC t t 9(a-d) conditions met 0 Yes ~No
`Verified and
`/SUSAN T TRANi
`Acknowledged
`Examiner's Signature
`
`0 x~r~;:~~e
`
`Initials
`
`STATE OR
`COUNTRY
`PA
`
`SHEETS
`DRAWINGS
`1
`
`TOTAL
`CLAIMS
`20
`
`INDEPENDENT
`CLAIMS
`1
`
`ADDRESS
`HOFFMANN & BARON, LLP
`6900 JERICHO TURNPIKE
`SYOSSET, NY 11791
`UNITED STATES
`TITLE
`METHODS OF TREATING ACNE
`
`FILING FEE FEES: Authority has been given in Paper
`to charge/credi

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