IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant:
`
`Ashley, Robert
`
`Examiner:
`
`Susan Tran
`
`Serial No.:
`
`13/277,789
`
`Group Art Unit: 1615
`
`Confirmation No:
`
`4179
`
`Docket:
`
`512-53 DIV/
`CONWRCE
`
`Filed:
`
`For:
`
`October 20, 2011
`
`Dated:
`
`February 22,2013
`
`Methods of
`Treating Acne
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`Certificate of EFS-Web Transmission
`I hereby certify that this correspondence is being transmitted to the
`United States Patent and Trademark Office via the Office's electronic
`filing system on
`Februarv 22. 2013
`
`Printed Name: _ __ ____,C""ar._.la....,B""rv""'a""n'---------
`
`Signature: /carla bryan/
`
`Response to November 19,2012 Final Office Action
`and Substance of February 7, 2013 Interview
`in Reply to February 19, 2013 Interview Summary
`
`Sir:
`
`In Reply to the November 19, 2012 Final Office Action and February 19, 2013
`
`Interview Summary, applicant respectfully requests the instant Response be considered.
`
`Accompanying this Response is a Request for Continued Examination, a 37 C.F.R. § 1.132
`
`Declaration by Dr. Vas ant Manna, a Terminal Disclaimer in view of US 7 ,232,572, and an
`
`Information Disclosure Statement.
`
`Listing of the Claims begins on page 2 of this paper.
`
`Remarks begin on page 5 of this paper.
`
`Dr. Reddy's Laboratories, Ltd., et al.
`v.
`Galderma Laboratories, Inc.
`IPR2015-__
`Exhibit 1071
`
`Exh. 1071, Page 1 of 17
`
`

`
`Applicant: Robert A. Ashley
`Serial No.: 13/277,789
`Filed: October 20, 2011
`Page 2 of 14
`
`Listing of the Claims:
`
`This listing of claims will replace all prior versions, and listings, of claims in the application.
`
`Claims 1-20 (Cancelled).
`
`21. (Previously Presented) A method for treating papules and pustules of rosacea in a
`human in need thereof, the method comprising
`administering orally to said human doxycycline, or a pharmaceutically acceptable salt
`thereof,
`in an amount that
`(i) is effective to treat the papules and pustules of rosacea;
`(ii) is 10-80% of a 50 mg dose of doxycycline; and
`(iii) results in no reduction of skin microflora during a six-month treatment, without
`administering a bisphosphonate compound.
`
`22. (Previously Presented)
`doxycycline monohydrate.
`
`The method according to Claim 21, wherein said doxycycline is
`
`The method according to Claim 22, wherein said doxycycline
`23. (Previously Presented)
`monohydrate is administered in an amount of 40 milligrams.
`
`The method according to Claim 23, wherein said doxycycline
`24. (Previously Presented)
`monohydrate is administered by sustained release.
`
`25. (Previously Presented) A method according to Claim 24, wherein said doxycycline
`monohydrate is administered once a day.
`
`The method according to Claim 22, wherein said doxycycline
`26. (Previously Presented)
`monohydrate is administered in a dose of 20 mg twice a day.
`
`2
`
`Exh. 1071, Page 2 of 17
`
`

`
`Applicant: Robert A. Ashley
`Serial No.: 13/277,789
`Filed: October 20, 2011
`Page 3 of 14
`
`The method according to Claim 21, wherein said doxycycline,
`27. (Previously Presented)
`or a pharmaceutically acceptable salt thereof, is administered in an amount which provides a
`serum concentration in the range of about 0.1 to about 0.8 11glml.
`
`28. (Previously Presented) A method for treating papules and pustules of rosacea in a
`human in need thereof, the method comprising
`administering orally to said human doxycycline, or a pharmaceutically acceptable salt
`thereof,
`in an amount that
`(i) is effective to treat the papules and pustules of rosacea;
`(ii) is 40-80% of a 50 mg dose of doxycycline; and
`(iii) results in no reduction of skin microflora during a six-month treatment, without
`administering a bisphosphonate compound.
`
`29. (Previously Presented)
`doxycycline monohydrate.
`
`The method according to Claim 28, wherein said doxycycline is
`
`The method according to Claim 29, wherein said doxycycline
`30. (Previously Presented)
`monohydrate is administered in an amount of 40 milligrams.
`
`The method according to Claim 30, wherein said doxycycline
`31. (Previously Presented)
`monohydrate is administered by sustained release.
`
`32. (Previously Presented) A method according to Claim 31, wherein said doxycycline
`monohydrate is administered once a day.
`
`The method according to Claim 29, wherein said doxycycline
`33. (Previously Presented)
`monohydrate is administered in a dose of 20 mg twice a day.
`
`3
`
`Exh. 1071, Page 3 of 17
`
`

`
`Applicant: Robert A. Ashley
`Serial No.: 13/277,789
`Filed: October 20, 2011
`Page 4 of 14
`
`The method according to Claim 28, wherein said doxycycline,
`34. (Previously Presented)
`or a pharmaceutically acceptable salt thereof, is administered in an amount which provides a
`serum concentration in the range of about 0.1 to about 0.8 11glml.
`
`35. (Previously Presented) A method for treating papules and pustules of rosacea in a
`human in need thereof, the method comprising
`administering orally to said human doxycycline, or a pharmaceutically acceptable salt
`thereof, in an amount of 40mg per day, wherein the amount results in no reduction of skin
`microflora during a six-month treatment, without administering a bisphosphonate compound.
`
`36. (Previously Presented)
`doxycycline monohydrate.
`
`The method according to Claim 35, wherein said doxycycline is
`
`The method according to Claim 36, wherein said doxycycline
`37. (Previously Presented)
`monohydrate is administered by sustained release.
`
`38. (Previously Presented) A method according to Claim 37, wherein said doxycycline
`monohydrate is administered once a day.
`
`The method according to Claim 36, wherein said doxycycline
`39. (Previously Presented)
`monohydrate is administered in a dose of 20 mg twice a day.
`
`The method according to Claim 35, wherein said doxycycline,
`40. (Previously Presented)
`or a pharmaceutically acceptable salt thereof, is administered in an amount which provides a
`serum concentration in the range of about 0.1 to about 0.8 11glml.
`
`4
`
`Exh. 1071, Page 4 of 17
`
`

`
`Applicant: Robert A. Ashley
`Serial No.: 13/277,789
`Filed: October 20, 2011
`Page 5 of 14
`
`REMARKS
`
`Claims 1-20 were previously cancelled. Claims 21-40 were previously added. Thus,
`Claims 21-40 are pending.
`
`Substance of Interview
`
`Applicant wishes to thank Examiner Susan Tran and Supervisory Patent Examiner
`Robert Wax for taking the time to discuss the instant application and for their courtesy during
`a personal interview with Ms. Cecile Cousin, Dr. Vasant Manna, Dr. Irving N. Feit and the
`undersigned on February 7, 2013. Dr. Manna stated to the examiners that he is a Medical
`Doctor with expertise in dermatology.
`
`The Claimed Invention
`
`During the interview applicant's representatives explained that the claimed invention
`is a method for treating papules and pustules of rosacea by oral administration of doxycycline
`(or a salt thereof). Papules and pustules occur on skin in facial rosacea. The doxycycline
`dose is expressed differently in each independent claim, i.e., 10-80% of a 50 mg, 40-80% of a
`50 mg dose, and a 40 mg. The claims recite that all these doses result in no reduction of skin
`microflora during a six-month treatment. Applicant's representative emphasized that the
`treatment of papules and pustules of rosacea with such a dose was major development in the
`treatment of this condition, and was unknown in the prior art.
`
`Obviousness Rejections under 35 U.S. C. §103(a) in View of Perricone and Pflugfelder
`
`In the Final Office Action, the examiner maintained the obviousness rejections, under
`35 U.S.C. §103(a), of Claims 21, 23, 25-28, 30, 32-35 and 38-40 over US 6,365,623
`(hereinafter "Perricone") in view of US 6,455,583 (hereinafter "Pflugfelder"); of Claims 24,
`25, 31, 32, 37 and 38 over Perricone in view of Pflugfelder and US 5,300,304; and of Claims
`
`5
`
`Exh. 1071, Page 5 of 17
`
`

`
`Applicant: Robert A. Ashley
`Serial No.: 13/277,789
`Filed: October 20, 2011
`Page 6 of 14
`
`22, 29 and 36 over Perricone in view of Pflugfelder and US Patent Application Publication
`No. 2002/0165220.
`
`During the interview, the undersigned reviewed the teachings of the cited references,
`as follows.
`
`Perricone teaches that lipoic acid can be topically applied to the faces of persons with
`acne. In some embodiments, "lipoic acid may also be used in combination with ... antibiotics
`such as tetracycline, clindamycin and erythromycin" to treat papules and pustules of acne
`(col. 8, lines 24-30). The undersigned pointed to col. 8, lines 27-32, of Perricone where the
`following is stated: "Lipoic acid may be added to an antibiotic preparation, or applied before,
`during, or after antibiotic treatment."
`
`During the interview, Dr. Manna stated that at a certain threshold dose, tetracycline
`exhibits antibiotic properties in humans. 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.
`
`Dr. Manna noted that Perricone groups tetracycline together with clindamycin and
`erythromycin; and 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. Dr. Manna concluded that a skilled artisan would believe that Perricone teaches
`that an antibiotic dose is necessary for his method.
`
`6
`
`Exh. 1071, Page 6 of 17
`
`

`
`Applicant: Robert A. Ashley
`Serial No.: 13/277,789
`Filed: October 20, 2011
`Page 7 of 14
`
`It is true, as the examiner pointed out, that Perricone mentions the potential adverse
`effects of the use of antibiotic compounds (i.e., tetracycline, clindamycin and erythromycin)
`and states that it may be advantageous to minimize antibiotic doses. However, Perricone
`does not state that a sub-antibiotic dose is effective in treating acne. The method of
`Perricone requires an antibiotic dose. A minimum antibiotic dose is still an antibiotic dose.
`
`Pflugfelder teaches treating the ocular disorder of meibomian gland disease (MOD)
`with sub-antimicrobial doses of tetracycline compounds.
`
`During the interview, Dr. Manna noted that MOD and rosacea are distinct diseases.
`Meibomian gland disease is an ocular disease. The papules and pustules of rosacea appear on
`the skin.
`
`No Reason to Combine the References
`
`During the interview, the undersigned stated that there is no basis to combine the cited
`references for at least two reasons.
`
`First, there would have been no reasonable expectation of success in achieving the
`presently claimed invention by the combination of the teachings of the cited prior art
`references.
`
`Dr. Manna elaborated. Perricone teaches treating a different ailment than Pflugfelder
`(i.e., acne vis-a-vis MOD). Perricone teaches treating a different organ of the body than
`Pflugfelder (i.e., skin vis-a-vis the eye). Perricone teaches a different treatment modality
`than Pflugfelder (i.e., antibiotic vis-a-vis sub-antibiotic). Thus, although a skilled artisan may
`have believed that a sub-antibiotic dose of tetracycline may lead to fewer side effects, the
`skilled artisan would have had no reason to believe that such sub-antibiotic dose would be
`effective in the method of Perricone.
`
`7
`
`Exh. 1071, Page 7 of 17
`
`

`
`Applicant: Robert A. Ashley
`Serial No.: 13/277,789
`Filed: October 20, 2011
`Page 8 of 14
`
`That is, success in treating an eye disease with a sub-antibiotic treatment is not
`relevant to treating a skin disease with an antibiotic treatment. Medical science is much too
`unpredictable to make such a connection. Thus, a skilled artisan would not combine the
`teachings of the references.
`
`Second, the undersigned pointed to the M.P.E.P. § 2143.01 VI, which is entitled, "The
`Proposed Modification Cannot Change the Principle of Operation of a Reference." That is, it
`is not proper to combine two references if the secondary reference would change the principle
`of operation of the primary reference. In the instant case, Perricone teaches antibiotic
`treatment; whereas, Pflugfelder teaches a mode other than antibiotic treatment by prescribing
`a sub-antimicrobial dose. Therefore, the two treatment modalities are based on different
`principles of operation. Thus, it is not proper to combine the teachings of the two references.
`
`In summary, it would not have been proper to combine a reference directed to treating
`acne with an antibiotic dose of tetracycline with a reference directed to treating an ocular
`disorder with a sub-antibiotic dose. Accordingly, withdrawal of the obviousness rejection
`was, and is, respectfully requested.
`
`Examiner's Response during the Interview
`
`The examiners graciously listened to the applicants' representatives. SPE Wax then
`asked Examiner Tran if she still had any issues that she wanted addressed. Examiner Tran
`requested that a Terminal Disclaimer be filed in view of US 7 ,232,572, and stated that she
`had three concerns. She suggested that such concerns may best be addressed in a 37 C.F.R. §
`1.132 Declaration.
`
`First, Examiner Tran requested a further description of MOD. The examiner
`suggested that an expert address that MOD is simply an ocular disorder thereby clearly
`distinguishing it from a skin condition.
`
`8
`
`Exh. 1071, Page 8 of 17
`
`

`
`Applicant: Robert A. Ashley
`Serial No.: 13/277,789
`Filed: October 20, 2011
`Page 9 of 14
`
`Second, the examiner requested an explanation of the phrase "meibomian gland
`disease associated with rosacea" at col. 4, lines 18-25, of Pflugfelder.
`
`Third, Examiner Tran suggested that an expert address whether a skilled artisan
`reading Perricone would understand that the Perricone treatment requires an antibiotic
`amount of tetracycline.
`
`Applicant's Reply to the Examiner's Specific Concerns
`
`As suggested by the examiner, accompanying this Response is a Terminal Disclaimer
`in view of US 7 ,232,572.
`
`As suggested by the examiner, accompanying this Response is a 1.132 Declaration by
`Dr. Vasant Manna. Dr. Manna is a Senior Medical Advisor I Project Leader at Oalderma
`R&D Inc., the assignee of the instant application. In his declaration, Dr. Manna reiterates and
`embellishes the statements he made during the personal interview.
`
`1.
`
`MOD is an ocular disorder that is clearly distinguished from a skin condition
`
`To address the examiner's first concern, in paragraphs 3-7 of his declaration, Dr.
`Manna establishes that MOD is a disease which is exclusive to the eye. In particular, Dr.
`Manna states that, "Meibomian glands are anatomically and functionally organs of the eye."
`And Dr. Manna describes MOD as involving "dysfunction of the rneibinnian gland'' w·hich
`"can lead to inflammation of th~~ meibomian glands (meibomianitis) and exc~~ss oil in the tear
`film." Dr. Manna also describes other symptoms of MOD, all of which are "unique to the
`eye."
`
`The disclosure in Pflugfelder concurs with Dr. Manna's statements. In particular, at
`col. 1, lines 8-10 and 19-23, Pflugfelder describes MOD as a "tear film and ocular surface
`
`9
`
`Exh. 1071, Page 9 of 17
`
`

`
`Applicant: Robert A. Ashley
`Serial No.: 13/277,789
`Filed: October 20, 2011
`Page 10 of 14
`
`disorder." Symptoms include "blurred or filmy vision, burning or foreign body sensations in
`the eye, photophobia, and pain." In addition, patients' "meibomian glands can atrophy."
`
`Pflugfelder describes the treatment of a patient having MOD as follows:
`
`According to the subject invention, treatment of a patient having MOD includes
`reducing or reversing irritation symptoms, delayed tear clearance, recurrent
`corneal epithelial erosion or aqueous tear deficiency. (Col. 3, lines 39-42.)
`
`All of these manifestations of MOD described by Pflugfelder relate to the eye. Thus,
`as Dr. Manna states, "Since MOD is an ailment that solely affects the eye, a skilled artisan
`would understand Pflugfelder as disclosing the use of tetracyclines to treat the eye."
`(Paragraph 8 of the declaration.)
`
`A clarification of the phrase "meibomian gland disease associated with
`2.
`rosacea" in Pflugfelder
`
`The examiner mentioned during the interview that Pflugfelder uses the phrase
`"meibomian gland disease associated with rosacea." See col. 4, lines 17-21, of Pflugfelder.
`The examiner asked for a clarification of this phrase.
`
`There is no discussion in Pflugfelder of the nature of the alleged association between
`MOD and rosacea. Pflugfelder does however mention that sometimes these two disorders
`may appear together. As stated by Dr. Manna, it is true that "Patients sometimes present with
`both symptoms ofrosacea and symptoms of MOD." However, despite appearing together,
`Dr. Manna clearly states that "MOD is a condition which is distinct from rosacea."
`(Paragraph 9 of the declaration.)
`
`10
`
`Exh. 1071, Page 10 of 17
`
`

`
`Applicant: Robert A. Ashley
`Serial No.: 13/277,789
`Filed: October 20, 2011
`Page 11 of 14
`
`Moreover, the alleged "association" between MOD and rosacea does not suggest a
`treatment for rosacea. That is, simply because two ailments present together does not mean
`that they are related in an etiological manner, or that they respond to the same treatment. For
`example, MOD may appear with (i.e., be "associated with") many different ailments, such as,
`for example, a headache. However, treatment of MOD would not suggest treatment of the
`headache.
`
`Furthermore, the rosacea with which Pflugfelder reports MOD is somehow associated
`is ocular rosacea (i.e., not skin rosacea). In particular, whenever Pflugfelder mentions
`rosacea, the focus is exclusively on meibomian glands which, as Dr. Manna states, are
`"anatomically and functionally organs of the eye." (Paragraph 4 of the declaration.)
`
`Specifically, the phrase "MOD associated with rosacea" is found three times in
`Pflugfelder. The first occurrence of the phrase is found in the paragraph bridging columns 3
`and 4. There, it is stated that the 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 to be inversely correlated with tear clearance." Dr. Manna
`states that from this description of tear composition and clearance, a skilled artisan would
`understand that MOD is associated with ocular rosacea. (Paragraph 10 of the declaration.)
`
`In the next paragraph, Pflugfelder states explicitly that the rosacea contemplated is
`ocular rosacea. See column 4, lines 5-10, especially line 9, where Pflugfelder refers to
`certain factors "that have been found to be strongly correlated with the development of
`ocular rosacea in our studies." (Emphasis added.).
`
`At col. 4, lines 17-21, Pflugfelder discloses treating MOD "associated with rosacea"
`by topical administration of a tetracycline analogue in an ointment or in solution (e.g., "eye
`drops"). Referring to such description, Dr. Manna states that "a skilled artisan would
`recognize a topical treatment of the eye as being for ocular symptoms." (Paragraph 11 of the
`declaration.)
`
`11
`
`Exh. 1071, Page 11 of 17
`
`

`
`Applicant: Robert A. Ashley
`Serial No.: 13/277,789
`Filed: October 20, 2011
`Page 12 of 14
`
`That the phrase "meibomian gland disease associated with rosacea" refers to ocular
`rosacea is confirmed by the third appearance of the phrase in example 5 at col. 8, line 55 et
`seq. of Pflugfelder. Example 5 discloses the treatment of eleven patients with MOD
`"associated with rosacea." The treatment included" ... topical administration to the ocular
`surface or the eyelids" of oxytetracycline. See col. 8, line 64. Table 2 at the top of col. 9
`summarizes the results of the experiment in example 5 of Pflugfelder. The title of table 2 is
`"Patients with Ocular Rosacea Treated with Oxytetracycline Ointment 1." (Emphasis
`added.)
`
`Referring to such description, Dr. Manna states that: "A skilled artisan would
`understand that treatment of MOD by topical administration 'to the ocular surface or the
`eyelids' means treating the eye." (Paragraph 12 of the declaration.)
`
`Dr. Manna concludes: "A skilled artisan would clearly understand, therefore, that the
`rosacea with which Pflugfelder reports MOD is somehow associated is ocular rosacea."
`(Paragraph 13 of the declaration. Emphasis added.)
`
`The unexplained association between MOD and ocular rosacea reported in Pflugfelder
`is, therefore, not relevant to treating the papules and pustules of facial rosacea. There is no
`disclosure or suggestion in Pflugfelder of treating any condition or symptom outside of the
`eye. There is no disclosure of treating any skin condition in Pflugfelder, let alone treating the
`papules and pustules of facial rosacea.
`
`12
`
`Exh. 1071, Page 12 of 17
`
`

`
`Applicant: Robert A. Ashley
`Serial No.: 13/277,789
`Filed: October 20, 2011
`Page 13 of 14
`
`A skilled artisan would understand that Perricone requires an antibiotic
`3.
`amount of tetracycline
`
`To address the examiner's third concern, Dr. Manna establishes that a skilled artisan
`reading Perricone would understand that the Perricone treatment requires an antibiotic
`amount of tetracycline .... " (Paragraphs 15-20 of the Manna Declaration.)
`
`As a first reason, Dr. Manna points to col. 8, lines 27-32, of Perricone. There it is
`stated that lipoic acid is added to "an antibiotic preparation, or applied before, during, or after
`antibiotic treatment. .. " (Paragraph 16 of the declaration.)
`
`As a second reason, Dr. Manna states that Perricone groups tetracycline together with
`two other compounds (i.e., clindamycin and erythromycin) which 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." (Paragraph 17 of the declaration.)
`
`As a third reason, Dr. Manna states that at the time Perricone was filed, as well as at
`the priority date of the instant application, "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." (Paragraph 18 of the declaration.)
`
`Applicant believes that the examiner's concerns have been addressed. If the examiner
`has any further questions or concerns, it is requested that the examiner contact applicant's
`undersigned representative at the telephone number provided below.
`
`13
`
`Exh. 1071, Page 13 of 17
`
`

`
`Applicant: Robert A. Ashley
`Serial No.: 13/277,789
`Filed: October 20, 2011
`Page 14 of 14
`
`For all the reasons given above, this application is now believed to be in condition for
`allowance. Notice to that effect at the examiner's earliest convenience is respectfully
`requested.
`
`Respectfully submitted,
`
`/susan a. sipos/
`Susan A. Sipos
`Registration No.: 43,128
`Attorney for Applicant
`
`HOFFMANN & BARON, LLP
`6900 Jericho Turnpike
`Syosset, New York 11791
`(516) 822-3550
`398554
`
`14
`
`Exh. 1071, Page 14 of 17
`
`

`
`~ .... ,,,...
`tl:-'-""~
`. \ ~ UNITED ST A 1ES p A 1ENT AND TRADEMARK OFFICE
`j
`' \ Q
`""
`~
`~.,..,co~
`
`0
`
`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
`
`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
`
`7590
`23869
`Hoffmann & Baron LLP
`6900 Jericho Turnpike
`Syosset, NY 11791
`
`02119/2013
`
`EXAMINER
`
`TRAN, SUSAN T
`
`ART UNIT
`
`PAPER NUMBER
`
`1615
`
`MAIL DATE
`
`02/19/2013
`
`DELIVERY MODE
`
`PAPER
`
`Please find 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)
`
`Exh. 1071, Page 15 of 17
`
`

`
`Applicant-Initiated Interview Summary
`
`Application No.
`
`Applicant(s)
`
`13/277,789
`Examiner
`
`SUSAN TRAN
`
`ASHLEY, ROBERT A.
`Art Unit
`
`1615
`
`All participants (applicant, applicant's representative, PTO personnel):
`
`(1) SUSAN TRANI ROBERT WAX.
`
`(2) IRVING N. FElT/SUSAN SIPOS.
`
`(3) CECILE COUSIN.
`
`(4) VASANT K. MANNA.
`
`Date of Interview: 07 Februarv 2013.
`Type: D Telephonic D Video Conference
`[8J Personal [copy given to: D applicant
`Exhibit shown or demonstration conducted: DYes
`If Yes, brief description: __ .
`
`D applicant's representative]
`DNa.
`
`Issues Discussed 0101 0112 0102 [8J1 03 OOthers
`(For each of the checked box( es) above. please describe below the issue and detailed description of the discussion)
`
`Claim(s) discussed: __ .
`
`Identification of prior art discussed: US 7.232.572. Pflugfelder eta/. and Perricone.
`
`Substance of Interview
`(For each issue discussed, provide a detailed description and indicate if agreement was reached. Some topics may include: identification or clarification of a
`reference or a portion thereof, claim interpretation, proposed amendments, arguments of any applied references etc ... )
`
`APPlicants' attornevs pointed out that there is no motivation to combine Pflugfelder with Perricone because Pflugfelder
`is directed to a method for treating meibomian gland. APPlicants pointed out that treating meibomian gland disease
`and rosacea are not related. It was suggested that APPlicants in a replv in writing. further point out the distinction
`between the claimed invention and what is taught on column 4. lines 18-25 of Pflugfelder. APPlicants will respond in
`writing along with a terminal disclaimer to US 7.232.572.
`
`Applicant recordation instructions: The formal written reply to the last Office action must include the substance of the interview. (See MPEP
`section 713.04). If a reply to the last Office action has already been filed, applicant is given a non-extendable period of the longer of one month or
`thirty days from this interview date, or the mailing date of this interview summary form, whichever is later, to file a statement of the substance of the
`interview
`
`Examiner recordation instructions: Examiners must summarize the substance of any interview of record. A complete and proper recordation of
`the substance of an interview should include the items listed in MPEP 713.04 for complete and proper recordation including the identification of the
`general thrust of each argument or issue discussed, a general indication of any other pertinent matters discussed regarding patentability and the
`general results or outcome of the interview, to include an indication as to whether or not agreement was reached on the issues raised.
`D Attachment
`/S. TRANI
`Primary Examiner, Art Unit 1615
`
`U.S. Patent and Trademark Off1ce
`PTOL-413 (Rev. 8/11/2010)
`
`Interview Summary
`
`Paper No. 20130212
`
`Exh. 1071, Page 16 of 17
`
`

`
`Manual of Patent Examining Procedure (MPEP), Section 713.04, Substance of Interview Must be Made of Record
`A complete written statement as to the substance of any face-to-face, video conference, or telephone interview with regard to an application must be made of record in the
`application whether or not an agreement with the examiner was reached at the interview.
`
`Summary of Record of Interview Requirements
`
`Title 37 Code of Federal Regulations (CFR) § 1.133 Interviews
`Paragraph (b)
`
`In every instance where reconsideration is requested in view of an interview with an examiner, a complete written statement of the reasons presented at the interview as
`warranting favorable action must be filed by the applicant. An interview does not remove the necessity for reply to Office action as specified in§§ 1.111, 1.135. (35 U.S. C. 132)
`
`37 CFR §1.2 Business to be transacted in writing.
`All business with the Patent or Trademark Office should be transacted in writing. The personal attendance of applicants or their attorneys or agents at the Patent and
`Trademark Office is unnecessary. The action of the Patent and Trademark Office will be based exclusively on the written record in the Office. No attention will be paid to
`any alleged oral promise, stipulation, or understanding in relation to which there is disagreement or doubt.
`
`The action of the Patent and Trademark Office cannot be based exclusively on the written record in the Office if that record is itself
`incomplete through the failure to record the substance of interviews.
`It is the responsibility of the applicant or the attorney or agent to make the substance of an interview of record in the application file, unless
`the examiner indicates he or she will do so. It is the examiner's responsibility to see that such a record is made and to correct material inaccuracies
`which bear directly on the question of patentability.
`
`Examiners must complete an Interview Summary Form for each interview held where a matter of substance has been discussed during the
`interview by checking the appropriate boxes and filling in the blanks. Discussions regarding only procedural matters, directed solely to restriction
`requirements for which interview recordation is otherwise provided for in Section 812.01 of the Manual of Patent Examining Procedure, or pointing
`out typographical errors or unreadable script in Office actions or the like, are excluded from the interview recordation procedures below. Where the
`substance of an interview is completely recorded in an Examiners Amendment, no separate Interview Summary Record is required.
`
`The Interview Summary Form shall be given an appropriate Paper No., placed in the right hand portion of the file, and listed on the
`"Contents" section of the file wrapper. In a personal interview, a duplicate of the Form is given to the applicant (or attorney or agent) at the
`conclusion of the interview. In the case of a telephone or video-conference interview, the copy is mailed to the applicant's correspondence address
`either with or prior to the next official communication. If additional correspondence from the examiner is not likely before an allowance or if other
`circumstances dictate, the Form should be mailed promptly after the interview rather than with the next official communication.
`
`The Form provides for recordation of the following information:
`-Application Number (Series Code and Serial Number)
`-Name of applicant
`-Name of examiner
`-Date of interview
`-Type of interview (telephonic, video-conference, or personal)
`-Name of participant(s) (applicant, attorney or agent, examiner, other PTO personnel, etc.)
`-An indication whether or not an exhibit was shown or a demonstration conducted
`-An identification of the specific prior art discussed
`An indication whether an agreement was reached and if so, a description of the general nature of the agreement (may be by
`attachment of a copy of amendments or claims agreed as being allowable). Note: Agreement as to allowability is tentative and does
`not restrict further action by the examiner to the contrary.
`-The signature of the examiner who conducted the interview (if Form is not an attachment to a signed Office action)
`
`It is desirable that the examiner orally remind the applicant of his or her obligation to record the substance of the interview of each case. It
`should be noted, however, that the Interview Summary Form will not normally be considered a complete and proper recordation of the interview
`unless it includes, or is supplemented by the applicant or the examiner to include, all of the applicable items required below concerning the
`substance of the interview.
`A complete and proper recordation of the substance of any interview should include at least the following applicable items:
`1) A brief description of the nature of any exhibit shown or any demonstration conducted,
`2) an identification of the claims discussed,
`3) an identification of the specific prior art discussed,
`4) an identification of the principal proposed amendments of a substantive nature discussed, unless these are already described on the
`Interview Summary Form completed by the Examiner,
`5) a brief identification of the general thrust of the principal arguments presented to the examiner,
`(The identification of arguments need not be lengthy or elaborate. A verbatim or highly detailed description of the arguments is not
`required. The identification of the arguments is sufficient if the general nature or thrust of the principal arguments made t