UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES. Ex parte XINTIAN MING and STEPHEN J.

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1 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES Ex parte XINTIAN MING and STEPHEN J. ROTHENBURGER Appeal Technology Center 1700 Before CHUNG K. PAK, CATHERINE Q. TIMM, and KAREN M. HASTINGS, Administrative Patent Judges. PAK, Administrative Patent Judge. DECISION ON APPEAL Appellants appeal under 35 U.S.C. 134(a) from the Examiner s refusal to allow claims 4 through 6 and 10 through 12, all of the claims pending in the above-identified application. 1 We have jurisdiction under 35 U.S.C See Appeal Brief ( App. Br. ) filed July 6, 2009, 2; and Examiner s Answer ( Ans. ) filed August 24, 2009, 2.

2 STATEMENT OF THE CASE The subject matter on appeal is directed to an antimicrobial composition comprising lauric arginate (LAE) and diiodomethyl-ptolysulfone (DIMPTS) (Spec. 1, ll. 6-8). According to page 3, lines 23-25, of the Specification, this composition may be used as a stand-alone antimicrobial formulation, or in combination with medical articles or medical devices. (Emphasis original.) Details of the appealed subject matter are recited in representative claim 4 2 reproduced from the Claims Appendix to the Appeal Brief as shown below: 4. An antimicrobial composition comprising: lauric arginate according to the following formula: and diiodomethyl-p-tolylsulfone. As evidence of unpatentability of the claimed subject matter, the Examiner relies on the following evidence at page 3 of the Answer: Ghosh US 6,149,927 Nov. 21, 2000 Urgell Beltran (Urgell) WO 03/ A1 May 30, Appellants have not separately argued the claims on appeal (App. Br. 5-15). Therefore, for purposes of this appeal, we select claim 4 and decide the propriety of the Examiner s rejections set forth in the Answer based on this claim alone in accordance with 37 C.F.R (c)(1)(vii). 2

3 Copending U.S. Application 11/389,824 filed by Xintian Ming et al. (Ming) on March 27, Appellants seek review of the following grounds of rejections set forth in the Answer 3 : 1. Claims 4 through 6 under 35 U.S.C. 103(a) as unpatentable over Urgell in view of Ghosh; 2. Claims 4 through 6 and 10 through 12 under 35 U.S.C. 103(a) as unpatentable over Ghosh in view of Urgell; 3. Claims 4 through 6 and 10 through 12 provisionally on the ground of nonstatutory obviousness-type double patenting as unpatentable over claims 1 through 20 of Ming in view of Ghosh. (See App. Br. 3). RELEVANT FACTUAL FINDINGS, PRINCIPLES OF LAW, ISSUE, ANALYSIS, AND CONCLUSION I. OBVIOUSNESS UNDER 35 U.S.C. 103 From the collective teachings of Urgell and Ghosh 4, the Examiner has determined that one of ordinary skill in the art would have had at least some reason or suggestion to employ Ghosh s antimicrobial agent, such as diiodomethyl-p-tolysulfone (DIMPTS), together with Urgell s lauric arginate (LAE) taught to be useful with a common antimicrobial agent. (See Ans. 3-6.) On the other hand, Appellants contend that one of ordinary skill in the art would have had no reason or suggestion to select diiodomethyl-p- 3 The Examiner has withdrawn the 103 rejection based on the combined disclosure of Cox (U.S. Patent 6,503,531) and Urgell (Ans. 2). 4 As recognized by Appellants at page 10 of the Appeal Brief, the Examiner has relied on the combined disclosures of Urgell and Ghosh, i.e., Urgell in view of Ghosh or Ghosh in view of Urgell, to reject the claims on appeal. 3

4 tolysulfone (DIMPTS) from the large number of antimicrobial agents listed in Ghosh as the antimicrobial agent of the antimicrobial composition taught by Urgell. (See App. Br. 7-8 and 10.) Appellants also contend that one of ordinary skill in the art would not have looked to the disclosures of Urgell and Ghosh to arrive at the claimed subject matter since they are from nonanalogous art. (See App. Br. 6 and 10.) Further, Appellants contend that the claimed subject matter imparts unexpected synergistic results, thereby rebutting any prima facie case of obviousness established by the Examiner. (See App. Br and ) Thus, the dispositive questions are: (1) Has the Examiner erred in determining that one of ordinary skill in the art would have been led to employ Ghosh s antimicrobial agent, such as diiodomethyl-p-tolysulfone (DIMPTS), as the common antimicrobial agent of the antimicrobial composition containing lauric arginate (LAE) taught by Urgell and (2) if the Examiner has not erred in making such determination, have Appellants demonstrated that the claimed subject matter as a whole imparts unexpected results, thereby rebutting any prima facie case of obviousness established by the Examiner? On this record, we answer both the questions in the negative. As correctly found by the Examiner at page 3 of the Answer, Urgell teaches an antimicrobial composition containing 0.001% to 1% by weight of a cationic surfactant corresponding to the claimed lauric arginate (LAE) and % to 2% by weight of at least one antimicrobial agent. (See also Urgell, Abstract and p. 4, ll. 1-5.) The Examiner has also correctly found at page 3 of the Answer that Urgell teaches LAE as activity enhancers of the traditional antimicrobials and combinations of LAE with traditional antimicrobials have a better activity than LAE or these antimicrobials by 4

5 themselves in the tested applications. (See also Urgell, p.1, ll and p. 2, ll ) Indeed, we note that Urgell, at page 3, lines 10-15, further emphasizes that: It has now been found that the antimicrobial activity of the combinations of LAE with most of the common antimicrobials used in formulations and preparations for skin and oral care is higher than the activity displayed by each of the components when used alone at the same dosage. Moreover, the Examiner has correctly found that Urgell broadly teaches employing common antimicrobial agents, including 2,4, 4 trichloro-2 - hydroxy-diphenylether (triclosan), in its antimicrobial composition and teaches such antimicrobial composition as being useful for cosmetic formulations and other preparations directed to body odor and oral care. (See also Urgell, p. 3, ll ) Although Urgell does not mention that its common antimicrobial agent useful for its antimicrobial composition includes diiodomethyl-ptolysulfone (DIMPTS), the Examiner has correctly found at pages 4 and 5 of the Answer that Ghosh lists common antimicrobial agents, including 2,4, 4 trichloro-2 -hydroxy-diphenylether (triclosan) and diiodomethyl-ptolysulfone (DIMPTS). (See also Ghosh, col. 2, ll and col. 2, l. 52 to col. 3, l. 63.) In particular, Ghosh describes two types of common biocides used in its solid compositions that provide controlled release of biocidal compounds which may be in the form of solid or liquid. (See col. 1, ll and col. 2, ll and col. 4, ll ) Ghosh identifies one common biocide as an antimicrobial agent, i.e., a microbiocide for inhibiting the growth of or controlling the growth of microorganism in a locus and lists common microbiocides (common antimicrobial agents). (See col. 2, ll. 27-5

6 34 and ) According to column 3, lines 59-63, of Ghosh, common antimicrobial agents include, among other things, 2, 4, 4 trichloro-2 - hydroxy-diphenylether (triclosan) and diiodomethyl-p-tolysulfone (DIMPTS). As correctly found by the Examiner at page 4 of the Answer, Ghosh teaches that its composition is useful for wherever the biocidal compound [i.e., microbiocide,] would be useful cosmetics and toiletries; shampoos; disinfectants and antiseptics medical devices odor control fluids; [and] coating. (See also Ghosh, col. 5, ll ) Given the above factual findings, we concur with the Examiner that one of ordinary skill in the art would have been led to employ Ghosh s antimicrobial agent, such as diiodomethyl-p-tolysulfone (DIMPTS), as the antimicrobial agent of the common antimicrobial composition containing lauric arginate (LAE) and an antimicrobial agent taught by Urgell, with a reasonable expectation of successfully enhancing the antimicrobial activity of the common antimicrobial agent, such as DIMPTS, used in, for example, cosmetic formulations or odor control fluids. 5 See, e.g., KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282 (1976) ( [W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious. ); see also Merck & Co., Inc. v. Biocraft Labs., Inc., 5 We also note Appellants admission at page 3 of the Specification, which acknowledges that the use of DIMPTS as an antimicrobial agent is desirable because it is a known broad spectrum antimicrobial agent. See In re Nomiya, 509 F.2d 566, (CCPA 1975) (The admitted prior art in applicant s Specification may be used in determining the patentability of a claimed invention.); see also In re Davis, 305 F.2d 501, 503 (CCPA 1962). 6

7 874 F.2d 804, 807 (Fed. Cir. 1989) (The disclosure in a prior art reference of compositions having a multitude of effective ingredient combinations does not render any particular formulation less obvious.) In reaching the above determination, we have carefully considered Appellants argument at pages 6 and 10 of the Appeal Brief that both Urgell and Ghosh are from non-analogous art. However, we are not persuaded that they are not from analogous art as indicated by the Examiner at page 8 of the Answer. As our reviewing court in In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004) stated: Two separate tests define the scope of analogous prior art: (1) whether the art is from the same field of endeavor, regardless of the problem addressed and, (2) if the reference is not within the field of the inventor's endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved. We find that both Urgell and Ghosh are from the same field of endeavor as the claimed subject matter since they, like the claimed subject matter, are directed to antimicrobial compositions as indicated supra. Even if Urgell and Ghosh are from different fields of endeavor than that claimed, we find that they still are reasonably pertinent to the particular problem which the inventors are involved. We find that Urgell, like the inventors, deals with solving a problem associated with producing an antimicrobial composition having a synergistic effect via using a cationic surfactant (LAE) with an antimicrobial agent. (Compare Urgell, pp. 2-3 with Spec. 4, 11, and 12.) We find that Ghosh, like the inventors, deals with solving a problem of using an antimicrobial composition on medical devices or as coatings to prevent or 7

8 reduce the effects of fungi and pathogens. (Compare Ghosh, cols. 2 and 5, with Spec. 3, 6, and 10.) Appellants also rely on synergistic results of using LAE and DIMPTS shown in Tables 1 and 2 at pages 11 and 12 of the Specification to demonstrate that the claimed invention imparts unexpected results as indicated supra. However, Appellants have not shown that such results are unexpected by one of ordinary skill in the art. In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972) (The burden of showing unexpected results is on the party asserting them.); In re Huellmantel, 324 F.2d 998, 1003 (CCPA 1963) (Synergism must be unexpected, for it to support nonobviousness.) As correctly found by the Examiner at page 11 of the Answer and supra, Urgell teaches that combinations of LAE with traditional antimicrobials have a better activity than LAE or these antimicrobials by themselves. In re Skoner, 517 F.2d 947, 948 (CCPA 1975) (Expected results are evidence of obviousness just as unexpected results are evidence of unobviousness). Notwithstanding Appellants arguments to the contrary at pages 13 and 14 of the Appeal Brief, Urgell s experiments shown in its Tables 1 and 2 support its statement regarding the synergistic effect of using LAE and a common antimicrobial agent. Appellants arguments at pages 13 and 14 of the Appeal Brief relating to Urgell s experiments conveniently ignore the amounts of the antimicrobial agent (triclosan) employed in the compared samples. In particular, Urgell shows a better antimicrobial activity for sample 8 having a small amount of a cationic surfactant (LAE) than sample 2 having no LAE even though sample 8 employed only 50% of the amount of the same antimicrobial agent, triclosan, used in sample 2. (See pp. 8-9, Tables 1 and 2.) 8

9 As also correctly found by the Examiner at page 10 of the Specification, Appellants have not shown that the showing in the Specification is reasonably commensurate in scope with the degree of protection sought by the claims on appeal. While the showing is limited to using particular ratios and amounts of LAE and DIMPTS to obtain synergistic results, the claims are not so limited. See, e.g., In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005) ( Even assuming that the results were unexpected, Harris needed to show results covering the scope of the claimed range. Alternatively Harris needed to narrow the claims. ); In re Greenfield, 571 F.2d 1185, 1189 (CCPA 1978) ( Establishing that one (or a small number of) species gives unexpected results is inadequate proof, for it is the view of this court that objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support. ) (quoting In re Tiffin, 448 F.2d 791, 792 (CCPA 1971)). Accordingly, based on the reasons set forth in the Answer and above, we determine that the preponderance of evidence weighs most heavily in favor of obviousness of the subject matter recited in claims 4 through 6 and 10 through 12 within the meaning of 35 U.S.C. 103(a). II. OBVIOUSNESS-TYPE DOUBLE PATENTING Appellants do not dispute that the claims of Ming would have suggested an antimicrobial composition containing LAE and a common antimicrobial agent, such as sulfones, and a medical device having such antimicrobial composition. Appellants rely on the same arguments directed to Ghosh and unexpected results in the context of the above obviousness rejections (App. Br. 12). Thus, based on the findings set forth above regarding Ghosh and unexpected result, we concur with the Examiner that 9

10 the preponderance of evidence supports the Examiner s determination that it would have been obvious to use DIMPTS (diiodomethyle-p-tolylsulfone) as the common antimicrobial agent of the antimicrobial composition recited in the claims of Ming. ORDER In view of the foregoing, it is ORDERED that the decision of the Examiner to reject claims 4 through 6 under 35 U.S.C. 103(a) as unpatentable over Urgell in view of Ghosh is AFFIRMED; FURTHER ORDERED that the decision of the Examiner to reject claims 4 through 6 and 10 through 12 under 35 U.S.C. 103(a) as unpatentable over Ghosh in view of Urgell is AFFIRMED; FURTHER ORDERED that the decision of the Examiner to reject claims 4 through 6 and 10 through 12 provisionally on the ground of nonstatutory obviousness-type double patenting as unpatentable over THE claims of Ming in view of Ghosh is AFFIRMED; and FURTHER ORDERED that no time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R (a)(1)(iv). AFFIRMED sld 10