Ex Parte Lee et al

Patent Trials and Appeals BoardMar 21, 2019

14489181 - (D) (P.T.A.B. Mar. 21, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/489,181 09/17/2014 108547 7590 03/25/2019 McDermott Will & Emery LLP 500 North Capitol Street NW Washington, DC 20001 FIRST NAMED INVENTOR Eun SooLee 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 091500-0532/8033.USOl 2183 EXAMINER WEST, THEODORE R ART UNIT PAPER NUMBER 1628 NOTIFICATION DATE DELIVERY MODE 03/25/2019 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): mweipdocket@mwe.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte EUN SOO LEE, APP ALA SAGI, and P ARMINDER SINGH Appeal2017-011821 Application 14/489, 181 1 Technology Center 1600 Before RICHARD M. LEBOVITZ, TA WEN CHANG, and RACHEL H. TOWNSEND, Administrative Patent Judges. TOWNSEND, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. Â§ 134(a) involving claims to a topical skin composition, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. Â§ 6(b). We affirm. STATEMENT OF THE CASE "The effectiveness of all skin care products is normally contingent upon delivery of the active ingredients therein through the stratum comeum and viable epidermis into the dermis layer of the skin structure." (Spec. ,r 4.) "This is normally a difficult proposition for water soluble active ingredients because the stratum comeum is a good water barrier." (Id.) The invention is 1 Appellants identify the real party in interest as Corium International, Inc. ( Appeal Br. 1.) Appeal2017-011821 Application 14/489,181 directed to a topically applied composition "to deliver one or more active agents that beneficially alters the skin's appearance." (Id. ,r 2.) Claims 1-8, 11-13, 18, 19, 22, 23, and 32 are on appeal. 2 Claim 1 is representative and reads as follows: 1. A topical skin composition, comprising: a skin-contacting layer comprised of (i) an adhesive mixture comprised of a water swellable, water-insoluble film forming polymer and a water-soluble film forming polymer in a ratio of between about 0.1-1.0; (ii) between about 15-55 wt% of a solvent mixture comprised of water, a monomeric polyol and an alpha hydroxyl acid ester or fatty alcohol; and (iii) between about 1-50 wt% of niacinamide. (Appeal Br. 6.) The following ground of rejection by the Examiner is before us on review: Claims 1-8, 11-13, 18, 19, 22, 23, and 32 under 35 U.S.C. Â§ I03(a) as unpatentable over Singh, 3 Lintner, 4 and Bissett. 5 DISCUSSION Obviousness The Examiner finds that Singh, while focused on teeth whitening compositions (Ans. 7), discloses that its disclosed compositions can be used for skin lightening (id. citing Singh ,r 64; Final Action 3). The Examiner 2 Claims 24--31 are pending, but stand withdrawn from consideration. (Appeal Br. 7-8.) 3 Singh et al., US 2004/0105834 Al, published June 3, 2004. 4 Lintner, US 2009/0029926 Al, published Jan. 29, 2009. 5 Bissett et al., US 2008/0025932 Al, published Jan. 31, 2008. 2 Appeal2017-011821 Application 14/489,181 finds that Singh discloses the skin lightening composition comprises "an adhesive, water-swellable, water-insoluble polymer (para. 0065 et seq.) mixed with a hydrophilic polymer (para. 0077 et seq.)," and includes "an active agent (para. 0096 et seq.)," "as well as a second agent." (Final Action 3--4.) The Examiner points out that nicotinamide (also known as niacinamide ), as recited in claim 1, is one active agent that may be included in Singh's composition. (Id. at 4 (citing Singh ,r 112).) The Examiner further finds that "[ t ]he amounts of the[] two polymers var[y] within wide ranges (para. 0067-68 and 0079), including amounts within the ratio recited in claim 1." (Id.) The Examiner also finds that "[m]any of the compounds described in the reference are a polyol within the meaning of claim 1, such as polyvinyl alcohol (para. 0080)." (Id.) The Examiner recognizes that nicotinamide is mentioned in a list of active agents that may be used in Singh's composition. Ans. 7. However, the Examiner finds that Bissett, which teaches a composition including a sugar amine as well as another skin care active, is also concerned with skin lightening compositions (i.e., "treating discontinuities in skin color such that skin tone/color becomes more uniform"), and teaches that niacinamide is a compound that is particularly useful for regulating skin condition in such compositions. (Final Action 5, Ans. 5 (pointing to Bissett ,r,r 57-70 providing "a long and detailed discussion ... of the importance of niacinamide and related compounds in skin lightening compositions" including that it (see para. 64) is "'particularly useful for regulating skin condition[s]' (para. 57)").) The Examiner also finds that Bissett teaches that compositions that include niacinamide "provid[ e] additive and/ or synergistic skin benefits" and the compositions have "good product stability and a 3 Appeal2017-011821 Application 14/489,181 reasonably long shelf-life." (Ans. 5.) Consequently, the Examiner concludes that it would have been obvious to specifically select niacinamide for use in the skin lightening composition of Singh in order to take advantage of the known beneficial property of this ingredient in a skin lightening composition. (Ans. 5; Final Action 5.) The Examiner recognizes further that Singh "does not specifically disclose that the skin-whitening compositions further include a fatty alcohol" as required by (ii) of claim 1. (Final Action 4.) The Examiner, however, finds that Lintner teaches a skin lightening composition that includes pal-KT (palmitoyl-lysine-threonine) or pal-KTTKS (palmitoyl-lysine-threonine- threonine-lysine-serine ), "optionally together with fatty alcohols (para. 0052) and skin- lightening agents (para. 0074)." (Final Action 4.) The Examiner notes that Lintner teaches that such compositions "are useful for promoting collagen growth (see Example 2 at para. 0084--104) and are beneficially used in compositions for treating hyperpigmented skin, such as age spots and freckles (para. 0032)." (Final Act. 4--5.) The Examiner further finds that Lintner considers the fatty alcohol to be a "structuring agent" that is "useful for assisting in the formation of gel network structures (para. 0051)." (Ans. 6.) The Examiner further finds that Singh's composition is a "gel composition" (Ans. 6 (citing Singh ,r,r 49, 60).) The Examiner concludes that it would have been obvious to one of ordinary skill in the art to include in the skin lightening composition of Singh, pal-KT or pal-KTTKS as well as a fatty alcohol as taught by Lintner "in order to take advantage of the beneficial properties of the ingredients" "such as promoting collagen growth." (Final Action 5.) 4 Appeal2017-011821 Application 14/489,181 The Examiner explains that such a combination would simply be using known compounds in accordance with their known or expected pharmaceutical properties and that selection of such known ingredients for "their art recognized uses [ and that such] would generally be considered to be prima facie obvious." (Ans. 6 (citing MPEP 2144.07), see also Final Action 5.) As to the recited concentrations of the claimed components, the Examiner finds [t]he cited references provide general teachings about the concentrations of the ingredients (see, e.g., Singh et al. at para. 0066-67; Linter at para. 0029 and 0069; and Bissett et al. at para. 0039, 0050, 0057-58, and 0185), and they acknowledge that some experimentation would be expected in order to arrive at useful compositions (see, e.g., Singh et al. at para. 0169-70; Linter at para. 0075; and Bissett et al. at para. 0239). (Final Action 6.) The Examiner concludes that it would have been an obvious matter of routine experimentation to arrive at the claimed amounts in light of these teachings. (Id.) The Examiner notes, that "[ w ]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05." (Id.) We agree with the Examiner's factual findings and conclusion that claim 1 would have been obvious to one or ordinary skill in the art from the cited references. N iacinamide Appellants contend that Singh focuses on teeth whitening compositions with only a passing mention of applying the composition in 5 Appeal2017-011821 Application 14/489,181 skin lightening and that even as to skin lightening Singh says that is obtained using hydrogen peroxide. (Appeal Br. 3--4 (citing Singh ,r 64).) Consequently, Appellants contend that there is no motivation in Singh or Bissett to select niacinamide for use in Singh's composition. (Id.) We do not find this argument persuasive. First, Singh does not assert that the only skin lightening compound that may be used in the invention is hydrogen peroxide. Rather, Singh discloses hydrogen peroxide as an example of a whitening agent that also has other therapeutic benefits that may be beneficial in a composition to be applied to skin (e.g., anti-acne). (Singh ,r 64.) Second, as the Examiner noted (Ans. 7), "[i]t is well settled that a prior art reference is relevant for all that it teaches to those of ordinary skill in the art." In re Fritch, 972 F.2d 1260, 1264 (Fed. Cir. 1992). Thus, it is not material that Singh is mostly focused on using the disclosed compositions for teeth whitening. We agree with the Examiner that Singh teaches that the disclosed compositions can be used for skin lightening (Singh ,r 64) and that such compositions are not limited to the inclusion of hydrogen peroxide as the lightening ingredient. That "Bissett concerns skin care composition[s]" and niacinamide (Appeal Br. 3), thus, does not render it a reference that would be non-analogous art. Bissett teaches that niacinamide ("vitamin B3") is particularly useful for regulating skin condition and that, when combined with a sugar amine, such as N-acetyl glucosamine, it is capable of providing an additive or synergistic skin benefit. (Bissett ,r,r 34, 38--40, 57, 64.) Bissett also teaches that the composition could additionally contain a skin lightening agent. (Id. ,r 74.) Consequently, while Singh identifies niacinamide in a long list of 6 Appeal2017-011821 Application 14/489,181 potential useful active agents that may be used in the skin lightening composition, Bissett provides a motivation to include it along with the sugar amine N-acetyl-glucosamine in the Singh composition that also includes a skin lightening agent. Fatty Alcohol Appellants argue that there is no motivation to arrive at the claimed solvent system that includes water, a monomeric polyol, and a fatty alcohol because there is no reason to include the fatty alcohol structuring agent of Lintner into the composition of Singh. (Appeal Br. 4 ("Singh ... nowhere discloses including an alpha hydroxyl acid ester or a fatty alcohol in a solvent system.").) Appellants note that Singh discloses a hydrogel composition that is "sufficiently formed by the water-swellable, water- insoluble polymer and the blend of a hydrophilic polymer with a complementary oligomer." (Reply Br. 5 (citing Singh ,r 23).) Thus, argue Appellants, "[a] skilled artisan would lack the motivation to add fatty alcohol for the purpose of assisting the formation of gel network structure." (Id.) We do not find Appellants' argument persuasive as it essentially argues the references separately. While Singh does not teach a composition that includes the dipeptides pal-KT or pal-KTTKS (Reply Br. 4--5), as the Examiner explained (Final Action 5), the rejection is based on the combination of Singh with Lintner and Bissett and combining together a number of ingredients. In particular, the Examiner's position is that it would have been obvious to include in the Singh composition, pal-KT or pal-KTTKS to provide the benefits that Lintner teaches such compounds can add to a skin composition that includes 7 Appeal2017-011821 Application 14/489,181 skin lighteners, i.e., collagen growth. (Final Action 5.) As Lintner explains, the fatty alcohol structuring agent "assists in providing rheological characteristics to the composition which contribute to the stability of the composition." (Lintner ,r 51.) As such, we agree with the Examiner that Lintner provides a reason one would have found it beneficial to include a fatty alcohol in the modified Singh composition, i.e., to provide, with its rheological characteristics, assistance in creating a stable gel network that includes a new ingredient that was not previously in the gel composition of Singh-pal-KT or pal-KTTKS. Appellants further argue that "[t]he Examiner has not provided persuasive rationale why a skilled artisan would choose fatty alcohol over the gelling agents listed at ,r,r [0054]-[0068] [of Lintner] for assisting the gel formation." (Reply Br. 5.) We do not find this argument persuasive Fatty acids are explicitly mentioned in Lintner as a structuring agent which may be included in its compositions. The fact that it appears in a list of other structuring agents, or that it may be present in addition to a thickening agent or as alternative to a thickening agent, does not make its choice any less obvious to pick when it is an explicit ingredient that Lintner teaches may be present in its compositions. We also find that Lintner teaches structuring agents separately from thickening agents and describes a function for the structuring agents which is not mentioned for the thickeners. Paragraph 52 refers to a list of suitable structuring agents and paragraph 53 through the middle of the paragraph identifies the preferred structuring agents from the list in paragraph 52. In the middle of paragraph 53, after the preferred structuring agents are identified, there is a sentence that states: "Thickening Agent (including 8 Appeal2017-011821 Application 14/489,181 thickeners and gelling agents)" and notes that these can be "useful as delivery agents." Lintner does not identify thickening agents as structuring agents that are delivery agents and paragraphs 54---68 simply identify "[n]onlimiting classes of thickening agents." Consequently, we conclude that the Examiner did provide a persuasive rationale to include a fatty alcohol in the composition: to provide, with its rheological characteristics, assistance in providing a stable gel network (Lintner ,r 51 ), a benefit that is not indicated in Lintner to be provided by the "thickening agent." Polyol Appellants raise for the first time in the Reply Brief that Singh does not teach the claimed monomeric polyol. (Reply Br. 4.) Appellants state: (Id.) In the Examiner's Answer on page 3, when discussing Singh in an attempt to show that Singh teaches or suggests the solvent mixture recited in claim 1, the Examiner states that "[ m Jany of the compounds described in the reference are a polyol within the meaning of claim 1, such as polyvinyl alcohol (para.0080)." Appellant[ s] respectfully submits that the Examiner was mistaken because polyvinyl alcohol is not an ingredient of the solvent mixture recited in claim 1 and 32 (both are the independent claims). "[T]he reply brief [is not] an opportunity to make arguments that could have been made in the principal brief on appeal to rebut the Examiner's rejections, but were not." Ex parte Borden, 93 USPQ2d 1473, 14 7 4 (BP AI 2010) (informative). As stated in Ex parte Borden, consideration by the Board of new arguments presented for the first time in the Reply Brief that could have been presented earlier would "vitiate the force of the requirement in Board Rule 37(c)(l)(vii) that '[a]ny arguments or 9 Appeal2017-011821 Application 14/489,181 authorities not included in the brief ... will be refused consideration by the Board, unless good cause is shown."' Id. The portion of the Answer that Appellants quote in order to raise the polyol argument was present in the Final Action at page 4. Thus, Appellants have not demonstrated any specific Examiner findings presented for the first time in the Answer necessitating this specific new argument in rebuttal in the Reply Brief. We do not find good cause for considering this new argument, and do not entertain it. 6 For the foregoing reasons, Appellants do not persuade us that the Examiner erred in rejecting claim 1 for obviousness over Singh, Lintner, and Bissett. Claims 2-8, 11-13, 18, 19, 22, 23, and 32 have not been argued separately and, therefore, fall with claim 1. 37 C.F.R. Â§ 4I.37(c)(l)(iv). SUMMARY We affirm the rejection of claims 1-8, 11-13, 18, 19, 22, 23, and 32 under 35 U.S.C. Â§ 103(a) as unpatentable over Singh, Lintner, and Bissett. 6 We do note that Singh teaches the use of solvents is contemplated: "In one embodiment of this liquid or gel film-former composition, the hydrogel contains sufficient water or other solvent to provide flowable property." (Singh ,r 168.) Singh also teaches that preservatives such as propylene glycol may be included in the composition. (Singh ,r 128.) Lintner also teaches that monomeric glycols are well known solvents and can be used in conjunction with the dipeptides described therein. (Lintner ,r 45.) 10 Appeal2017-011821 Application 14/489,181 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a). AFFIRMED 11