IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Examiner:
`
`Susan Tran
`
`Group Art Unit: 1615
`
`Docket:
`
`512-53 DIV/
`CONIIIR.CE
`
`Dated:
`
`February 22, 2013
`
`Applicant:
`
`SerialNo.:
`
`Ashley, Robert
`
`13/277,789
`
`Confinnation No: 4179
`
`Filed:
`
`For:
`
`October 20, 2011
`
`Methods of
`Treating Acne
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`Declaration under 37 C.F.R. §1.132
`
`Sir:
`
`I, Vasant Manna, am a Senior Medical Advisor I flroject Leader at Galdenna
`1.
`R&D Inc., the assignee of the instant application. I am a medical doctor with a
`specialty in dennatology. My curriculum vitae is attached.
`
`I am familiar with the prosecution history of the instant application. I have
`2.
`reviewed the following references cited in the application: US 6,365,623
`( .. Perricone") and US 6,455,583 (''Pflugfelder'').
`
`Meibomian glands are sebaceous glands that are located on the rim of the
`3.
`eyelids. These glands are responsible for the supply to the eye of sebum, an oily
`substance that, inter alia, prevents evaporation of the eye's tear film.
`
`Meibomian glands do not appear anywhere in the body except on the rim of
`4.
`the eyelids, and have no function outside of the eye. Meibomian glands are
`anatomically and functionally organs of the eye.
`
`Dr. Reddy's Laboratories, Ltd., et al.
`v.
`Galderma Laboratories, Inc.
`IPR2015-__
`Exhibit 1072
`
`Exh. 1072
`
`
`
`Examiner:
`
`Susan Tran
`
`Group Art Unit: 1615
`
`Docket:
`
`512-53 DIV/
`CONIIIR.CE
`
`Dated:
`
`February 22, 2013
`
`Applicant:
`
`SerialNo.:
`
`Ashley, Robert
`
`13/277,789
`
`Confinnation No: 4179
`
`Filed:
`
`For:
`
`October 20, 2011
`
`Methods of
`Treating Acne
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`Declaration under 37 C.F.R. §1.132
`
`Sir:
`
`I, Vasant Manna, am a Senior Medical Advisor I flroject Leader at Galdenna
`1.
`R&D Inc., the assignee of the instant application. I am a medical doctor with a
`specialty in dennatology. My curriculum vitae is attached.
`
`I am familiar with the prosecution history of the instant application. I have
`2.
`reviewed the following references cited in the application: US 6,365,623
`( .. Perricone") and US 6,455,583 (''Pflugfelder'').
`
`Meibomian glands are sebaceous glands that are located on the rim of the
`3.
`eyelids. These glands are responsible for the supply to the eye of sebum, an oily
`substance that, inter alia, prevents evaporation of the eye's tear film.
`
`Meibomian glands do not appear anywhere in the body except on the rim of
`4.
`the eyelids, and have no function outside of the eye. Meibomian glands are
`anatomically and functionally organs of the eye.
`
`Dr. Reddy's Laboratories, Ltd., et al.
`v.
`Galderma Laboratories, Inc.
`IPR2015-__
`Exhibit 1072
`
`Exh. 1072
`
`
`
`Applicant: Robert Ashley
`Serial No.: 13/277,789
`Docket No.: 512-53 DIV/CON IIIRCE
`Page 2
`
`Meibomian gland disease (MGD) involves dysfunction ofthe meibomian
`5.
`gland. Such dysfunction can lead to inflammation ofthe meibomian glands
`(meibomianitis) and excess oil in the tear film
`
`Meibomian gland disease frequently presents with at least one of the following
`6.
`symptoms: dry eye; buming, itching and stickiness ofthe eye; foreign body sensation
`in the eye; eye watering; photophobia; and intennittent blurred vision. Allthese
`symptoms are unique to the eye.
`
`Since MGD is a disease of the eye, a patient presenting with the symptoms of
`7.
`MGD should be referred to a physician specializing in ocular disorders, such as an
`ophthalmologist.
`
`Pflugfelder discloses the use oftetracyclines to treat MGD. Since MGD is an
`8.
`ailment that solely affects the eye, a skilled artisan would understand Pflugfelder as
`disclosing the use of tetracyclines to treat the eye.
`
`Patients sometimes present with both symptoms ofrosacea and symptoms of
`9.
`MGD. However, MGD is a condition which is distinct from rosacea. MGD is not
`rosacea.
`
`In the paragraph bridging columns 3 and 4 of Pflugfelder, it is stated that the
`10.
`activity of gelatinase B " ... is markedly increased in the tear fluid of patients with
`meibomian gland disease associated with rosacea," and that the " ... activity of
`gelatinase B appears tobe inversely correlated with tear clearance." From this
`description oftear composition and clearance, a skilled artisan would understand that,
`in this case, MGD happened to appear with ocular rosacea.
`
`At col. 4, lines 17-21, Pflugfelder discusses treating MGD "associated with
`11.
`rosacea" by topical administration of a tetracycline analogue in an ointment or in
`solution (e.g., "eye drops"). From this description, a skilled artisan would recognize
`that Pflugfelder discloses a topical treatment ofthe eye for ocular symptoms.
`
`Exh. 1072
`
`
`
`Applicant: Robert Ashley
`Serial No.: 13/277,789 ,
`Docket No.: 512-53 DIV /CON IIIRCE
`Page 3
`
`At col. 8, beginning at line 55, of Pflugfeld er, the treatment of eleven patients
`12.
`with MGD associated with rosacea is described. The treatment included " ... topical
`administration to the ocular surface or the eyelids" of oxytetracycline. A skilled
`artisan would understand that treatment of MGD by topical administration "to the
`ocular surface or the eyelids" means treating the eye.
`
`A skilled artisan would clearly understand, therefore, that the rosacea with
`13.
`which Pflugfelder reports MGD is somehow "associated" is ocular rosacea. There is
`no suggestion in Pflugfelder oftreating the skin.
`
`Facial rosacea is a disease ofthe skin. A patient presenting with the
`14.
`symptoms of facial rosacea, such as, for example, the papules and pustules of rosacea,
`should be referred to a dermatologist.
`
`A skilled artisan reading Perricone would understand that Perricone discloses
`15.
`treating acne with an antibiotic amount oftetracycline. That the amount of
`tetracycline must be antibiotic is readily apparent for several reasons.
`
`First, at col. 8, lines 27-32, of Perricone, the following is stated: "Lipoic acid
`16.
`may be added to an antibiotic preparation, or applied before, during, or after antibiotic
`treatment. .. " Thus, Perricone is clearly prescribing an antibiotic treatment.
`
`Second, Perricone groups tetracycline together with clindamycin and
`17.
`erythromycin. Clindamycin and erythromycin do not have anti-inflammatory
`properties. The property that these three compounds have in common is that they are
`all antibiotic. Thus, it is apparent that such antibiotic property is what Perricone
`teaches is required for his treatment.
`
`Exh. 1072
`
`
`
`Applicant: Robert Ashley
`Serial No.: 13/277,789
`DocketNo.: 512-53 DIV/CONII/RCE
`Page 4
`
`Third, at the time Perricone was filed, i.e., December 1999, as well as the
`18.
`priority date ofthe instant application, i.e., September 26, 2001, acne was thought to
`be caused by bacteria, P. acnes. Thus, a skilled artisan would have understood from
`Perricone that an antibiotic preparation was required for the treatment of acne.
`
`At a certain thresho1d dose and above, tetracycline exhibits antibiotic
`19.
`properties. Depending on various factors, including the severity of an ailment, a
`physician may prescribe tetracycline at a dose that is well above the antibiotic
`threshold dose, at a minimum antibiotic dose, or at a dose somewhere in between such
`doses. As the dosage is increased, adverse effects increase. Nonetheless, above the
`threshold dose, treatment with tetracycline will be an antibiotic treatment.
`
`Although a skilled artisan may have believed that a sub-antibiotic dose of
`20.
`tetracycline may lead to fewer side effects, the skilled artisan wou1d have no reason to
`believe that such sub-antibiotic dose wou1d be effective in the method of Perricone.
`
`Before the present invention, a dermatalogist would not have prescribed a 40
`21.
`mg dose of doxycycline to treat acne or to treat rosacea.
`
`I hereby declare that all Statementsmade herein ofmy own knowledge are true
`22.
`and that all statements made on information and belief are believed to be true. Further
`that these statements were made with the knowledge that willfully false Statements
`and the like so made are punishable by fine or imprisonment or both under Section
`I 001 of Title 18 of the United States Code, and that such willfully false statements
`may jeopardize the validity ofthe application of any patent issued thereon.
`
`-'\""\ ...... \..
`\--(_ \o L_.-..... \-:;)_
`Dated: _________ .....
`..;::::,
`J- 1-
`
`398623
`
`Respectfully submitted,
`
`~1!..--c:::._
`
`Vasant Manna
`
`Exh. 1072
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