Ex Parte Dussaud et alDownload PDFBoard of Patent Appeals and InterferencesJun 20, 201211487533 (B.P.A.I. Jun. 20, 2012) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte ANNE DUSSAUD and ANTHONY CECE __________ Appeal 2011-012931 Application 11/487,533 Technology Center 1600 __________ Before TONI R. SCHEINER, DONALD E. ADAMS, and STEPHEN WALSH, Administrative Patent Judges. WALSH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) from the rejection of a claim directed to a method of selecting compositions having enhanced hydration value. The Patent Examiner rejected the claim for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal 2011-012931 Application 11/487,533 2 STATEMENT OF THE CASE The claim on appeal reads as follows: 1. Method of selecting compositions having enhanced hydration value comprising: a) selecting at least one skin site to which a control composition without tested moisturizing component(s) is applied and one skin site on the same skin surface to which a composition with tested moisturizing component(s) applied; b) prior to performing the wash protocol and applying control and non-control compositions, establishing a baseline skin hydration value through measurement of control Cc0 and non-control site Cnc0 or sites; c) applying said control composition and non-control composition to skin sites followed by rinsing and drying; d) recording multiple skin hydration values on the site or sites on which the control and non-control compositions have been applied for about 5 to 30 minutes; e) determining for each site a post-wash hydration value by subtracting a measured average baseline skin conductivity measured prior to wash on the same skin site from measured value of skin conductivity after the wash protocol or (Cct-Cc0) and (Cnct-Cnc0) where Cct and Cnct are measured conductivities at a given time; and f) determining a hydration enhancement value by calculating the mean change from baseline difference between the applied product and the control averaged across all subjects tested (1 or more) and all time points between about 5 to 20; and (g) selecting compositions having enhancement hydration value >27 after determining hydration value in step (f). The Examiner rejected claim 1 under 35 U.S.C. § 103(a) as unpatentable over Glover,1 Zhang,2 Cochrane,3 and “Mean.”4 1 David A. Glover et al., US 2005/0169879 A1, Aug. 4, 2005. 2 Shuliang L. Zhang et al., Near infrared imaging for measuring and visualizing skin hydration. A comparison with visual assessment and electrical methods, 10 J. BIOMEDICAL OPTICS 1-7 (2005). Appeal 2011-012931 Application 11/487,533 3 ISSUE The Issue The Examiner’s position is that Glover taught compositions exhibiting long lasting moisturizing properties and a testing protocol. (Ans. 5.) According to the Examiner, Glover’s testing protocol differed from Appellants’ by not explicitly including rinsing and drying, and by not selecting compositions by reference to “enhancement hydration value >27.” (Ans. 6.) Zhang taught skin hydration measurements, and that “[s]tudy clinicians performed a single application of liquid cleanser to each test site, rinsed and pat dry.” (Id.) The Examiner concluded it would have been obvious to add these rinsing and drying steps to Glover’s. (Id.) The Examiner found that (i) Glover taught subtracting the initial value from the final value; (ii) Cochrane evidenced that “subtracting baseline measurement is well known in order to determine the change from baseline;” and (iii) the “Mean” article explained the formula and uses for an arithmetic mean. (Id. at 7.) The Examiner concluded: It would be obvious to one of ordinary skill in the art at the time the invention was made to subtract the initial value from the final value of the tested sample and to subtract the baseline data to which 3 Meta-analysis of continuous data, The Cochrane Collaboration (2002), downloaded from www.archive.org/web/20040515005851/http://www.cochrane- net.org/openlearning/H… on March 15, 2010. 4 Mean, WIKIPEDIA, THE FREE ENCYCLOPEDIA, downloaded from web.archive.org/web/20040222211824/http://en.wikipedia.org/wi… on March 21, 2010. Appeal 2011-012931 Application 11/487,533 4 the tested is being compared based on the teachings of [Glover] and Cochrane. It would be obvious to one of ordinary skill in the art to find the average across all subjects tested and all time points as [the Mean article] teaches summing all observations divided by the number of observations. Subtracting baseline data and subtracting the initial test point of the tested sample as well as finding the mean of the all data (population and time data) are commonly used statistical measurements to interpret data as is taught by [Glover], Cochrane and [the Mean article], and therefore would be prima facie obvious to use on the data collected by [Glover] and Zhang. (Id.) The Examiner set out further findings correlating the claimed steps to the prior art steps. (Id. at 7-8.) Appellants contend: Glover discloses only a preferred "moisture index” of skin of at least 35%. Knowledge of such index has nothing whatsoever to do with measurement of hydration value or recognition that, to have skin of enhanced hydration value, it is necessary to select specifically compositions of measured value >27. While Glover may be concerned in a broad, general sense with moisture or hydration, it fails to disclose the specific method taught by applicants to recognize and know how to achieve enhanced hydration. In short, Glover simply does not teach or suggest our specific method for achieving enhanced hydration. Indeed, Glover could not possibly disclose our specific method because Glover does not even recognize that the result of following our method leads to compositions, when selected, which have enhanced hydration. Applicants would note that the secondary references do nothing to remedy the fundamental deficiency of Glover reference. (App. Br. 9-10.) The Examiner responds that “as stated in the instant specification, the enhancement value of greater than 27 is not a critical value (instant specification, page 10, line 25-30). The art teaches the desirability and selection for compositions with higher hydration values.” (Ans. 10.) Appeal 2011-012931 Application 11/487,533 5 Findings of Fact 1. We adopt the Examiner’s findings concerning the scope and content of the prior art. (See Ans. 5-10.) 2. The Specification states: While applicants have defined on HEV value of greater than about 27 as significant, it should be understood that any value might in theory be considered significant depending on what is considered “sufficient” hydration for the defined audience. Thus, hydration values greater than about 15 (e.g., control with no additive has HEV of 15), preferably greater than about 20 and more preferably greater than about 27 might be used. (Spec. 10, ll. 28-31.) 3. The Specification states: The hydration value can be measured, for example, using electrical capacitance and conductance of the skin as indicators of the hydration. These in turn can be measured using equipment such as Skicon® 200 hygrometers. Other equipment to measure hydration may include Corneometer® CM420 hydrometer and Servo Med EPI® evaporimeters. Besides conventional corneometry, additional methods for measuring hydration may include nuclear magnetic resonance spectroscopy (NMR-5) and transient thermal transfer (TTT). In any event, methods for obtaining hydration values are well known and well understood by those skilled in the art. (Id. at 11, ll. 13-21.) 4. Glover’s disclosure related to “topical cosmetic compositions that exhibit long lasting moisturizing properties, as well as to methods of using these compositions.” (Glover, 1, ¶ 1.) 5. According to Glover, its composition imparts long-lasting moisturization to the skin as measured by a moisture index. Several analytical methods and/or devices well known Appeal 2011-012931 Application 11/487,533 6 to those of ordinary skill in the art may be used to measure the moisture index. One such device is the Novameter DPM 9003 (Nova Corporation, Portsmouth, N.H.). (Id. at 4, ¶ 49.) 6. Glover stated: The Novameter DPM 9003 is a dermatological laboratory instrument commonly used in the cosmetics industry. In using the DPM 9003, a remote, uniform-pressure sensor probe is employed. Readings are taken by lacing the sensor probe on the surface of the skin. The device displays DPM values (a moisture index), which represent relative values of skin characteristics based on the capacitive reactance of the skin. (Id. at 4, ¶ 50.) 7. Glover stated: The values of the DPM 9003 device range between a low of 90 to a high of 999. Lower values generally represent dry skin while higher values represent hydrated skin. It should be appreciated that the conversion of Novameter values into percentage increases in moisturization is well known in the cosmetic industry, and is calculated based on the readings obtained from the Novameter DPM 9003 according to the following equation: percentage increase=[(final value-initial value)/initial value ]x100. (Id. at 4, ¶ 51.) Appeal 2011-012931 Application 11/487,533 7 8. Glover stated: In a preferred embodiment, the moisture index of skin treated with the compositions of the present invention about 10 minutes after application is at least about 35% higher, more preferably at least about 45% higher, and most preferably at least about 50% higher, relative to untreated skin. More preferably, the moisture index of skin treated with the compositions of the present invention about 20 minutes after application is at least about 30% higher, more preferably at least about 40%, and most preferably at least about 45%, relative to untreated skin. (Id. at 4-5, ¶ 52.) Principles of Law “[T]he discovery of an optimum value of a variable in a known process is usually obvious.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1368 (Fed. Cir. 2007). The rationale for determining the optimal parameters for prior art result effective variables “flows from the ‘normal desire of scientists or artisans to improve upon what is already generally known.’” Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)). “[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.” In re Aller, 220 F.2d 454, 456 (CCPA 1955). Analysis We agree with the Examiner that claim 1 defines a testing protocol differing in ways that would have been obvious from Glover’s and Zhang’s testing protocols. Appellants disclose that skin hydration values can be measured using electrical capacitance and conductance of the skin (FF3), but Appeal 2011-012931 Application 11/487,533 8 the evidence is that Glover used a similar kind of capacitance device for hydration measurements (FF 6). We therefore reject Appellants’ contention that Glover’s skin moisture index has nothing whatsoever to do with measurement of hydration value. We find the Examiner reasonably concluded, based on Appellants’ disclosure, that an enhancement hydration value greater than 27 has no critical significance. The Specification explains that “any value might in theory be considered significant depending on what is considered “sufficient” hydration for the defined audience.” (FF 2.) Glover’s teachings evidence that hydration values were known as the kind of result-effective- variable it would have been obvious to optimize. (See FF 8.) See Pfizer, 480 F.3d at 1368. Finally, while Appellants express their measurements in different units than Glover used, Appellants have not established that there is a material difference between the value recited in claim 1 and the hydration levels in the prior art. Glover indicated that conversion of electrical measurements into percentage increases in moisturization was well known in the art. (FF 7.) The rejection properly shifted the burden to Appellants to show that the difference in calculating units would not have been obvious, and the hydration level Appellants’ step f selects for is patentably distinct from the hydration level selected for in Glover’s testing protocol. SUMMARY We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable over Glover, Zhang, Cochrane, and “Mean.” Appeal 2011-012931 Application 11/487,533 9 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). 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