Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Detailed Action
Previous Rejections
Applicants' arguments, filed 02/09/26, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 14-16 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Pitner et al. (US PG Pub. 2012/0058057) in view of Bortolin et al. (US PG Pub. 2011/0015120) and Kraemer et al. (US PG Pub. 2003/0012749).
Pitner et al. discloses anti-dandruff agents, see title. Pitner et al. teaches a composition comprising special ammonium carboxylates, see abstract. Pitner et al. suggests that the formulation can include piroctone and ciclopiroxolamine as an active ingredients, see [0159], [0163] and claim 8.
Pitner does not exemplify explicit use of ciclopiroxolamine as an active ingredients, in treating seborrhoeic dermatitis or dandruff.
Bortolin et al. teaches pharmaceutical and cosmetic composition comprising ciclopirox, see title. Bortolin et al. teaches that said composition are used in the treatment of dermatological disorders such as seborrhoeic dermatitis and dandruff, see abstract. The reference teaches use of ciclopiroxolamine used in seborrhoeic dermatitis and dandruff, see [0006-0007], [0100] and [0102] and [0104]. The formulation can be in the form of a lotion, cream or shampoo, see [0043]. The amount disclosed is 0.5% in [0050] and example 2.
Kraemer et al. teaches antimycotically active substance such as hydroxypyridone, ciclopiroxolamine and piroctone, see claim 8.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized as an active ingredient, ciclopiroxolamine and piroctone for treating seborrhoeic dermatitis and dandruff as taught by Pitner et al. One of ordinary skill would have been motivated to do so because Pitner suggests use of active ingredient such as ciclopiroxolamine and piroctone can be used in treating dandruff, Bortolin teaches use of ciclopiroxolamine used in seborrhoeic dermatitis and dandruff, see [0006-0007], [0100], [0102] and [0104] and Kraemer et al. teaches hydroxypyridone such as ciclopiroxolamine and piroctone are antimycotically active substance. The expected result would be treatment of seborrheic dermatitis and dandruff by using ciclopiroxolamine and piroctone on the hair or scalp applied topically and furthermore application of the composition comprising the two ingredients and repeating the step of applying and rinsing would have been obvious to one of ordinary skill in the art for optimum results.
Applicant argues about Pitner et al. that paragraphs [0159] and [0163] of Pitner et al. '057 are part of the examples. They disclose lists of compounds that could be added to the formulations disclosed in the tables in paragraphs [0158] and [0160], respectively. These formulations all contain a specific antifungal active ingredient (i.e., compound 1136). This compound is present in all the formulations in these tables, in proportions ranging from 0.01% to 2% of the formulation. This compound was selected for its fungicidal activity against Malassezia furfur (see paragraph [0150] of Pitner et al. '057). The compound is particularly suitable for anti-dandruff compositions (paragraph [0152] of Pitner et al. '057). As such, the formulations disclosed in paragraphs [0159] and [0163] of Pitner et al. '057 do not contain only the combination of ciclopiroxolamine and piroctone olamine as antifungal active ingredients… Pitner et al. '057 do not disclose or suggest the administration of the combination of ciclopiroxolamine and piroctone olamine for the treatment of seborrheic dermatitis.
These arguments are not persuasive because the open-ended comprising language of instant claims do not preclude reading any other component into the claims.
Applicant further argues that Bortolin et al. '120 disclose administering ciclopiroxolamine only with two other active ingredients, etidronic acid and lactoferrin. Indeed, Bortolin et al. '120 disclose the use of ciclopiroxolamine in the treatment of seborrheic dermatitis and dandruff, but only in combination with etidronic acid and/or lactoferrin (paragraph [0011]). When ciclopiroxolamine is used alone, its activity is reduced due to the presence of ferric ions from stainless steel production systems and equipment used in pharmaceutical and cosmetic compositions or present in excipients used in the production of such compositions (paragraph [0008] of Bortolin et al. '120).
These arguments are not persuasive because Combination of cicloporoxolamine and piroctone olamine was known in the art for treating dandruff as discussed above and one of ordinary skill would have chosen the two ingredients for treating dandruff with the expectation of obtaining similar results of treating dandruff results. Additionally, the open-ended comprising language of instant claims do not preclude reading any other component into the claims. According to Applicant, Kraemer does not overcome the deficiencies of the references discussed above. The rationale for using Kraemer has been discussed above. The rejections are therefore maintained.
Claims 17-21 and 23-26 are free of art. The closest prior art of record does not teach the synergistic effect in treating seborrheic dermatitis and synergistic anti-dandruff effect by administration of effective amounts of sole active ingredients, ciclopiroxolamine and piroctone olamine as claimed and demonstrated in the instant specification in Tables 1-2 and pages 14-17.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM.
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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