Ex Parte Wirth et alDownload PDFPatent Trial and Appeal BoardOct 28, 201612107526 (P.T.A.B. Oct. 28, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 12/107,526 04/22/2008 23599 7590 11/01/2016 MILLEN, WHITE, ZELANO & BRANIGAN, P,C 2200 CLARENDON BL VD. SUITE 1400 ARLINGTON, VA 22201 Corinna Wirth 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. MERCK-2734-COl 9889 EXAMINER BERRIOS, JENNIFER A ART UNIT PAPER NUMBER 1613 NOTIFICATION DATE DELIVERY MODE 11/01/2016 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): docketing@mwzb.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CORINNA WIRTH, HERWIG BUCHHOLZ, and CHRISTOPHE CAROLA Appeal2014-004433 Application 12/107,526 Technology Center 1600 Before JEFFREYN. FREDMAN, RICHARD J. SMITH, and DAVID COTTA, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL r-T"I .. • • .. 1 .. ,..... ,_ TT r'1 I'\ l\ -1,..... Al • "1 • "1 • , ,.. .. ims 1s an appear unaer j) u.~.L. s U4 mvo1vmg crnm1s to a memoa of treating inflammation or filtering UV radiation. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Statement of the Case Background "The object of care cosmetics is wherever possible to obtain the impression of youthful skin ... For example, existing skin damage, such as 1 Appellants identify the Real Party in Interest as Merck Patent GMBH (see App. Br. 1 ). Appeal2014-004433 Application 12/107,526 irregular pigmentation or the development of wrinkles, can be compensated for by covering powders or creams" (Spec. 2:6-11). "Another approach is to protect the skin against environmental influences which lead to permanent damage and thus ageing of the skin. The idea is therefore to intervene in a preventative manner and thus to delay the ageing process" (Spec. 2:11-15). The Claims Claims 16-23 and 29-35 are on appeal. Claim 29 is representative and reads as follows: 29. A method of topically treating inflammation or filtering UV radiation comprising topically administering to a person in need thereof a cosmetic formulation comprising a compound of the formula IA in which R1, R2 and R3 are each, independently of one another, OH, CH3COO, an alkoxy radical having from 1 to 8 carbon atoms or a monoglycoside radical, R 4 is a mono- or diglycoside radical, wherein is bonded to the glycoside radical via an -0- group, and R8 is OR, CH3COO, an alkoxy radical having from 1 to 8 carbon atoms or a monoglycoside radical, 2 Appeal2014-004433 Application 12/107,526 and in which one or more hydrogen atoms in the OH groups of the glycoside radical(s) may each, independently of one another, also be replaced by acetyl or by alkyl radicals having from 1 to 8 carbon atoms, and where, in each case independently of one another, sulfate or phosphate may also be bonded to one or more hydroxyl groups of the compounds of the formula IA, wherein the compound of the formula IA is prepared synthetically or is in the form of a plant extract, a purified plant extract or in the form of the pure substance prepared from the plant extract, and a cosmetically acceptable carrier for topical application to treat inflammation topically. The issue The Examiner rejected claims 16-23 and 29-35 under 35 U.S.C. § 103(a) as obvious over Lanzendorfer,2 Tsuruga,3 Pearce,4 and Menendez5 (Ans. 3-5). The Examiner finds that "Lanzendorfer teaches cosmetic and dermatological formulations having flavonoids . ... Suitable flavonoids are quercetin, rutin, etc. The formulations are useful to combat ageing of the 2 Lanzendorfer et al., US 2002/0099095 Al, published July 25, 2002 ("Lanzendorfer"). 3 Tsuruga et al., Biologically Active Constituents of Magnolia salicifolia: Inhibitiors of Induced Histamine Release from Rat Mast Cells, 39 CHEM. PHARM. BULL. 3265-71 (1991) ("Tsuruga"). 4 F .L. Pearce and A. Truneh, Inhibition of histamine release from rat peritoneal mast cells treated with the ionophore A2 318 7. Implications for the mode of action of anti-allergic compounds, 11 AGENTS AND ACTIONS 44--50 (1981) ("Pearce"). 5 Menendez et al., US 4,882,170, issued Nov. 21, 1989 ("Menendez"). 3 Appeal2014-004433 Application 12/107,526 skin and inflammation reaction" and that "[t]opical application is the preferred means of applying the formulation" (Ans. 3). The Examiner acknowledges that "Lanzendorfer does not teach the use of tiliroside in the cosmetic formulation" (Ans. 4). The Examiner finds that "Tsuruga teaches that the extracts of the flower buds Magnolia salicifolia show remarkable anti-allergy effects" and that "[a]saryladehyde and tiliroside ... were the most effective at inhibiting histamine release" (Ans. 4). The Examiner finds that Pearce teaches "inhibition of histamine release from rat peritoneal mast cells. Antiallergy drugs such as quercetin, doxantrazole, etc. are shown to inhibit the release of histamine" (Id.). The Examiner finds that Menendez teaches "a method for the prevention or inhibition of an allergy reaction or tissue inflammation, which comprises the administration of an anti-allergy drug" (Id.). The Examiner finds it obvious that tiliroside and quercetin are functional equivalents, as they are both taught by the prior art to have anti-allergy properties which inhibit the release of histamine. Thus it would be obvious to substitute quercetin for the tiliroside of Tsuruga, with a reasonable expectation of success. Furthermore, Menendez demonstrates that it's well known in the art to administer topical compositions which inhibit the release of histamine (Ans. 5). The issue with respect to this rejection is: Does the evidence of record support the Examiner's conclusion that Lanzendorfer, Tsuruga, Pearce, and Menendez render the claims obvious? 4 Appeal2014-004433 Application 12/107,526 Findings of Fact 1. In response to a requirement by the Examiner to elect a species for examination, Appellants elected tiliroside as the compound of formula I (see Resp. to Restriction Requirement 6/23/2011 ). 2. Lanzendorfer teaches "cosmetic and dermatological formulations comprising flavonoids, their glycosides and, if appropriate, combinations thereof' (Lanzendorfer i-f 1 ). 3. Lanzendorfer teaches "to choose the flavonoid or flavonoids A) from the group consisting of quercetin" and "to choose the flavone glycosides A) from the group consisting of rutin" (Lanzendorfer i-fi-154--55). 4. Lanzendorfer teaches "the use of the active compounds or active compound combinations according to the invention for combatting and/or prophylaxis of ageing of the skin and inflammatory reactions caused by exposure to oxidation" (Lanzendorfer i-f 105). 5. Lanzendorfer teaches that "[t]opical application is preferred for this use" (Lanzendorfer i-f 110). 6. Tsuruga teaches the "extracts of the flower buds of Magnolica salicifolia showed remarkable anti-allergy effects in passive cutaneous anaphylaxis (PCA) test" (Tsuruga, Abstract). 7. Tsuruga teaches that to "isolate bioactive compounds contained in the methanol extract [of Magnolica salicifolia] it was fractionated ... MG-9 was identified as tiliroside (11) ... and MG-10 as acteoside (12)" (Tsuruga 3267-3268). 5 Appeal2014-004433 Application 12/107,526 8. Table Ill of Tsuruga is reproduced below: '1\'\~E lit J~t:H·sh~~:rr EHl':\.:~'S ($f t-~~ah-::J. {\~-tn~~~:r.=~$ ~~""">.~: l~-t~~Jt~:ifr.$ ~«li<,l".i:dk •>~ WM~~i~it;,~; R""k''"'~ fr>)fl~ :lt:i~ Mw<:! Ce'l:s lr.>~~1,~~v.o;~ h_y Contpi:f1rnd 48/~) ~)l" (\m A &'.\:)fi;tltonc HJ :)7 ·"6 1i .t~ As+.'lr):fakklw~.e (li ~ j?" 46 .·.·~ :l.;4---Dimo;:tlw~yd~~i:s;irns:<)''l· 0 .... ,l % ··'' ~~~<.•hd{J) ~-t~.tr:(~~t~x~~::~ (4) l~ ···4 ~ ~ l -{2, --t ~-Tifa~~h~>~yt~'l~~i:iyi} 4-6 4 "'! r .... ~~--Pf~~f.~Ul~".:;.ih~~~~ ('1} v·e~~~r~c .~~d- t~~ ::N Hl --~) iH .. A.$t~~hts.:. (~) !$ ~ 4i Y> Nix.."'.:\l.*lYfh:tri.~~ nm M 9 }9 ~ T!r·i!~£itk (ll) :'i'> ~~~} 5i :'IS A~t~osid(:' {l~} 4~ 1l §l 24 "'""'-"'-'-"-'-"""""""'"· ... -.-.-.-.-.-.-.-.-.-...... .,..,..,.._ .......... •.•.•······---.-·····--············---------""'~~ ................. .._,_,_,_.._._.._ .................... . "Table III summarizes the inhibitory activities of the isolated compounds on histamine release from rat mast cells induced by compound 48/80 or Con A. Asaryladehyde (2) and tiliroside (11) were the most effective in the experiments where compound 48/80 was used as an inducer" (Tsuruga 3268). 9. Pearce teaches "quercetin, doxantrazole and theophylline effectively inhibited histamine secretion in calcium-free media, in both the presence and absence of the chelating agent" (Pearce 46, col. 2 to 47, col. 1). 10. Pearce teaches that the "secretion of chemical mediators (principally the vasoactive amine histamine) from the mast cell is of great clinical interest because of the involvement of these substances in allergic and inflammatory conditions" (Pearce 44, col. 1 ). 6 Appeal2014-004433 Application 12/107,526 11. Menendez teaches "prevention or inhibition of an allergic reaction or tissue inflammation . . . which method comprises administration by inhalation of an anti-allergy drug to a patient" (Menendez, Abstract). Principles of Law "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007). Analysis Claim 1 We adopt the Examiner's findings of fact and reasoning regarding the scope and content of the prior art (Ans. 3-5; FF 1-11) and agree that the claims are obvious over Lanzendorfer, Tsuruga, Pearce, and Menendez. We address Appellants' arguments below. Appellants contend that: it is to be noted that Pearce's own disclosure refutes the PTO' s assertion with respect to the use of tiliroside in inhibiting histamine release. Since Pearce explicitly states that the mechanism of histamine release is unclear, there is no suggestion or motivation for one skilled in the art to use Tsuruga's compounds in a manner taught by Pearce because nothing in the cited documents points to the compounds (e.g., quercitin and tiliroside) being functional equivalents of one another. (App. Br. 6). We are not persuaded. Pearce teaches that histamines are involved with inflammatory conditions (FF 10). Pearce further teaches that "quercetin, doxantrazole and theophylline effectively inhibited histamine secretion" (FF 9). Tsuruga teaches that tiliroside was also an effective 7 Appeal2014-004433 Application 12/107,526 inhibitor of histamine release (FF 8). Thus, the ordinary artisan would have recognized that quercetin and tiliroside are equivalent for the purpose of inhibiting histamine release. These teachings, combined with Lanzendorfer's teaching to topically apply compounds including quercetin to treat or prevent inflammation (FF 3-5), reasonably would have rendered it obvious to the ordinary artisan to apply known equivalent compounds that have anti-histamine and consequent anti-inflammatory activity such as the tiliroside of Tsuruga (FF 8). We recognize, but find unpersuasive, Appellants' contention that the generic anti-allergic properties of the compounds do not provide credence to the Examiner's broad assertion of functional equivalency. In fact, based purely on the different structural features and the properties of the respective compounds in cosmetic formulations, it is submitted that the Examiner's assertion regarding functional equivalency is without merit. Functional equivalency does not require structural similarity, as shown in KSR itself, where the mechanical ("Asano ... and the Rixon ... are complex mechanical linkage-based devices") and electrical ("an adjustable pedal with a single pivot reflecting pedal position combined with an electronic control") pedals differed substantially in structure but represented "the mere substitution of one element for another known in the field." KSR, 550 U.S. at 416, 423. Therefore, when the Examiner finds it obvious to utilize a known anti-histamine, tiliroside, in the place of another known anti- histamine, quercetin, even though they differ structurally, this substitution is a predictable use of prior art elements according to their established functions. 8 Appeal2014-004433 Application 12/107,526 Appellants contend that "[t]iliroside is an exceptional flavonoid wherein the monoglycoside is further modified by a coumaric acid residue. The lipophilic coumaric acid residue strongly influences the solubility, the color and the stability of tiliroside in comparison to other flavonoids such as quercetin" (App. Br. 6). We find this argument unpersuasive because this represents attorney argument, not evidence. Appellants provide no evidence that tiliroside would have been expected to have unexpected properties relative to quercetin, but simply argue this point. However, "attorney argument [is] not the kind of factual evidence that is required to rebut a prima facie case of obviousness." In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). Appellants contend that Tsuruga generically points to a use of tiliroside compounds against allergies, but provides no hint or suggestion for formulating cosmetic compositions for topical administration. It should be noted in this context that the in vitro tests disclosed in Tsuruga do not suggest that tiliroside can be substituted for quercitin and used in Lanzendorfer' s cosmetic formulations. (App. Br. 7). We find this argument unpersuasive because the Examiner relies upon a combination of references, not Tsuruga alone, to render the claims obvious. In particular, Lanzendorfer teaches that "[t]opical application is preferred" (FF 5) for cosmetics (FF 2). "Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). 9 Appeal2014-004433 Application 12/107,526 Appellants contend that: The facts in the instant case are analogous to that in [Leo Pharm. Prods., Ltd v. Rea, 726 F.3d 1346, 1354 (Fed. Cir. 2013)]. Nothing in the disclosures cited by the PTO teach or suggest topically treating inflammation or filtering UV radiation comprising topically administering compounds of Formula I or pharmaceutical compositions comprising the same. Until the advancement made by the inventors of the instant application, no one had proposed a new formulation that could be applied topically to treat inflammation or filter UV radiation. (App. Br. 8). We find this argument unpersuasive because Lanzendorfer specifically teaches cosmetic formulations comprising flavonoids (FF 2) for treatment of inflammation (FF 4) by topical application (FF 5). Appellants' own Specification recognizes that tiliroside is a known prior art flavonoid (see, e.g., Spec 24:25-27). Therefore, the Examiner reasonably finds it \'l/ould have been obvious to use kno\'l/n prior art flavonoids that inhibit histamine (FF 8) and are therefore anti-inflammatory (FF 10) in the cosmetic containing flavonoids of Lanzendorfer that is designed for treatment of inflammation (FF 4). Appellants contend that the "passage of time between public availability of the cited references is also evidence for the instantly claimed invention not being obvious to try. Tsuruga, which generically teaches quercetin compounds extracted from plants, was published 11 years before the filing date of the instant application" (App. Br. 9). We are not persuaded. "The mere age of the references is not persuasive of the unobviousness of the combination of their teachings, absent evidence that, notwithstanding knowledge of the references, the art 10 Appeal2014-004433 Application 12/107,526 tried and failed to solve the problem." Jn re Wright, 569 F.2d 1124, 1127 (CCP A 1977). Appellants have provided no evidence addressing this point. Appellants contend that "the claimed invention is directed to methods for 'topically treating inflammation or filtering UV radiation comprising topically administering compounds of Formula I' [.] These are not compositions claims which merely recite the intended use" (App. Br. 9). While we agree with Appellants that the process step of "treating inflammation or filtering UV radiation" is not an intended use recitation, we agree with the Examiner that regarding "the method of treating inflammation, this is taught by Lanzendorfer" (Ans. 9). That is, Lanzendorfer teaches a method of treating inflammation (FF 4), and the combination of references renders the use of tiliroside in that method obvious, not simply rendering the product itself obvious. Conclusion of Law The evidence of record supports the Examiner's conclusion that Lanzendorfer, Tsuruga, Pearce, and Menendez render the claims obvious. SUMMARY In summary, we affirm the rejection of claims 16-23 and 29-35 under 35 U.S.C. § 103(a) as obvious over Lanzendorfer, Tsuruga, Pearce, and Menendez. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED 11 Copy with citationCopy as parenthetical citation