Ex Parte Silcock et al

Patent Trial and Appeal BoardMay 29, 2014

10548231 (P.T.A.B. May. 29, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE ________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ________________ Ex parte DEREK W. SILCOCK and MICHELLE DELBONO1 ________________ Appeal 2012-009664 Application 10/548,231 Technology Center 1600 ________________ Before DONALD E. ADAMS, ERIC B. GRIMES, and JOHN G. NEW, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL 1 The real party-in-interest is Ethicon, Inc. Appeal 2012-009664 Application 10/548,231 2 SUMMARY Appellants file this appeal under 35 U.S.C. § 134(a) from the Examiner’s Final Rejection of claims 1-5, 7, 11-13, 15, and 18. Specifically, claim 1 stands rejected as unpatentable under 35 U.S.C. § 112 (second paragraph) as being indefinite. Claims 1-5, 7, 11-13, 15, and 18 stand rejected as unpatentable under 35 U.S.C. § 103(a) as being obvious over Cullen et al. (WO 2004/026200 A2, April 1, 2004) (“Cullen”). Claims 1-5, 7, 11-13, 15, and 18 also stand rejected as unpatentable under 35 U.S.C. § 103(a) as being obvious over Watt et al. (WO 98/00180, January 8, 1998) (“Watt”). Claims 1-5, 7, 11-13, 15, and 18 stand further rejected as unpatentable under 35 U.S.C. § 103(a) as being obvious over Watt et al. (GB 2314842 A, June 28, 1996) (“Watt GB”). Claim 15 stands rejected as unpatentable under 35 U.S.C. § 103(a) as being obvious over the combination of Watt GB and Cullen. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. NATURE OF THE CLAIMED INVENTION Appellants’ invention is directed to a wound dressing material comprising a low-moisture hydrocolloid matrix having oxidized cellulose distributed therein. In one embodiment, the material comprises a matrix of dried sodium carboxymethyl cellulose gel having fibers of oxidized regenerated cellulose dispersed therein. Also provided are the use of such materials in the treatment of wounds, and the manufacture of such materials Appeal 2012-009664 Application 10/548,231 3 by drying aqueous gels containing dispersed particles of oxidized cellulose. Abstract. GROUPING OF CLAIMS Because Appellants make the same argument for all of the claims on appeal, we select independent claim 1 as representative of these claims. See App. Br. 5-8. Claim 1 recites: 1. A wound dressing material comprising a low-moisture hydrogel matrix having oxidized cellulose distributed therein and wherein the wound dressing material is in the form of a plasticized solid sheet or layer and wherein the wound dressing material comprises from about 1% to 40% by weight of oxidized cellulose, from about 1% to 50% by weight of water, and from about 10% to 80% by weight of plasticizer and is substantially free of collagen and gelatin. App. Br. 9. ISSUES AND ANALYSES A. Rejection under 35 U.S.C. § 112 (second paragraph) Issue Appellants argue that the Examiner erred in finding that the limitation of claim 1 reciting that the claimed composition is “substantially free of collagen and gelatin” is indefinite under 35 U.S.C. § 112 (second paragraph). App. Br. 5. Analysis Appellants argue that the limitation “substantially free of collagen and gelatin” appears in Appellants’ Specification, which was published as Appeal 2012-009664 Application 10/548,231 4 US Appl. Ser. No. 2007/0020318 (the “’318 application”) and refers to a preferred embodiment. App. Br. 5 (citing ’318 application, ¶ [0009]). Paragraph [0009] of the ’318 application recites, in relevant part: The term “hydrogel” in this context does not include gels or films comprising substantial amounts (e.g., more than 50% by weight) of gel-forming proteins or peptides such as collagen or gelatin. Preferably, the hydrogel material according to the present invention is substantially free of collagen and gelatin, and more preferably it is substantially free of other gel-forming proteins or peptides. App. Br. 5 (quoting ’318 application, ¶ [0009]) (emphasis added by Appellants.) Appellants argue that, although [T]here are no numerical limits for what amounts of collagen or gelatin would define “substantially free” it is well accepted that use of the term “substantially free” would be understood to exclude or only cover amounts of such components that would not adversely affect the described benefits of the invention. App. Br. 5. Appellants contend that such benefits include stable oxidized cellulose compositions and amounts of collagen and gelatin that should not inhibit the in vivo breakdown of the hydrogel material “so as to provide sustained release [of] the oxidized cellulose into the wound.” App. Br. 5-6 (citing ’318 application, ¶¶ [0006]; [0009]) (emphasis added by Appellants). Appellants argue further that Example 1 of their Specification supports their contention that the claimed compositions that did not include collagen and gelatin exhibit stable compositions “for at least 6 weeks at 37o C in ambient atmosphere’” as evidenced by the observation that the “ORC fibers when viewed under a microscope did not exhibit any swelling or Appeal 2012-009664 Application 10/548,231 5 dissolution” in the hydrogel matrix. App. Br. 6 (quoting ’381 application, ¶ [0042]). The Examiner responds that Appellants’ argument that the limitation “substantially free of collagen and gelatin” would be understood by one of ordinary skill in the art to “include those amounts of collagen and gelatin that would not adversely affect the described benefits of the invention” does not cure the indefiniteness of the limitation because the Specification does not correlate any amount of collagen to any adverse effects. Ans. 14. The Examiner finds that the only mention of the amount of collagen in Appellants’ Specification is found on page 2, which is quoted above as ¶ 9 of the published application. Id. The Examiner finds that one of ordinary skill in the art would not be able to correlate the amount of collagen or gelatin to the occurrence of any adverse effects, including effects affecting the recited benefits. Ans. 14. Consequently, finds the Examiner, one of ordinary skill in the art would be unable to test for any effects on any “benefits,” for any given amount of collagen or gelatin within the claimed composition. Ans. 14-15. We are not persuaded by Appellants’ arguments, which are largely tautological. Appellants argue that a composition would meet the requirement of being “substantially free of collagen and gelatin” if the amount of collagen or gelatin did not adversely affect the described benefits of the invention, and therefore imply that any amount of collagen or gelatin that did not adversely affect the described benefits would therefore be one that is “substantially free of collagen and gelatin.” But Appellants’ Specification makes no mention of such a test, or state that collagen and/or gelatin, in any amount, might adversely affect the benefits described and Appeal 2012-009664 Application 10/548,231 6 indeed makes no direct or explicit mention of how these benefits would be determined. Appellants’ Example 1 describes that a matrix consisting of milled ORC fibers combined with K-Y Jelly (which contains no collagen or gelatin) showed no swelling or dissolution of the ORC fibers after six weeks. See Spec., p. 9, ll. 12-34. However, Appellants’ Specification also describes an embodiment of the invention that “does not include . . . substantial amounts (e.g.[,] more than 50% by weight) of … collagen or gelatin,” although it provides no data concerning whether such a hydrogel would provide results equivalent to those of Example 1, or indeed whether including more than 50% collagen or gelatin would provide such results. See Spec., p. 2, ll. 24-27. The Federal Circuit has held that a claim is not indefinite due to ambiguity when the meaning of the claim language is readily ascertained from the description in the specification. Howmedica Osteonics Corp. v. Tranquil Prospects, Ltd., 401 F.3d 1367, 1371 (Fed. Cir. 2005); see also, generally, Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc) (claims are construed in the context of the specification and prosecution history, as they would be understood by persons in the same field of endeavor). Appellants’ Specification provides an example of one successful embodiment with no collagen or gelatin, but also describes an embodiment in which the collagen or gelatin concentration may constitute as much as 50% of the hydgrogel in the matrix. However, Appellants’ Specification provides the artisan of ordinary skill no way of knowing what concentration value between 0 and 50% of collagen and/or protein constitutes being “substantially free” of those compounds, nor does it Appeal 2012-009664 Application 10/548,231 7 provide any way of correlating the concentration with the alleged benefit. We consequently agree with the Examiner that a person of ordinary skill in the art would find that the claim term “substantially free of collagen and gelatin” as presented by Appellants’ Specification to be indefinite and we decline to reverse the Examiner’s rejection on this ground. B. Rejections under 35 U.S.C. § 103 Issue 1 Appellants argue that the Examiner impermissibly employed hindsight in finding that Cullen teaches or suggests the limitations of claim 1. App. Br. 6. We therefore address the issue of whether the Examiner so erred. Analysis Appellants argue that Cullen discloses multitudes of combinations of components and thousands of potential combinations of components that comprise wound dressings. App. Br. 6. According to Appellants, the Examiner bases the rejection on one out of the thousands of potential combinations of components and concentrations. App. Br. 5-6. Appellants contend that the Examiner cannot point to any motivation of obviousness other than that the “instantly claimed compositions are nothing more than a combination of known components used for their known uses to make a known product.” App. Br. 6. Appellants argue that the Examiner misses the whole point of the invention, viz., to form stable oxidized cellulose compositions; according to Appellants, this motivation is not provided by Appeal 2012-009664 Application 10/548,231 8 the reasoning of the Examiner, particularly regarding the “negative proviso of an absence of collagen and gelatin.” Id. The Examiner responds that Cullen is drawn to wound dressing compositions comprising oxidized regenerated cellulose (“ORC”). Ans. 15. The Examiner finds that Cullen also teaches all of the components of claim 1, and percentages recited in claim 1 on a single page (page 5). Id. The Examiner finds that even though a plurality of embodiments is taught or suggested by Cullen, the number of potential embodiments is limited and reasonable. Id. We agree with the Examiner. Cullen teaches: Preferably, the chitosan makes up at least 5%, more preferably at least 10%, 20% or 30% of the composition. Preferably, the Oxidized cellulose also makes up at least 5%, more preferably at least 10%, 20% or 30% of the composition. Preferably, the chitosan and oxidized cellulose together make up at least 25% by weight, more preferably 50% or 75% by weight of the wound dressing material, and in some embodiments at least 90% by weight of the material. In certain preferred embodiments, the material consists essentially of the chitosan and oxidized cellulose. Other components of the material according to the invention may include 0-25% by weight, for example from about 1 to about 20% by weight, of one or more other biocompatible polysaccharides, for example alginates such as sodium alginate or calcium alginate, starch derivatives such as sodium starch glycolate, cellulose derivatives such as methyl cellulose or carboxymethyl cellulose, or glycosaminoglycans such as hyaluronic acid or its salts, chondroitin sulfate or heparin [sic] sulfate. The materials according to the present invention may also comprise up to about 25% by weight, for example from about 1 to about 20% by weight, of one or more structural proteins selected from the group consisting of fibronectin, fibrin, laminin, elastin, collagen and mixtures Appeal 2012-009664 Application 10/548,231 9 thereof. Preferably the protein comprises collagen, and more preferably it consists essentially of collagen. The materials according to the present invention may also comprise up to about 20% by weight, preferably from about 2% to about 10% by weight of water. The material according to the present invention may also contain 0-40% by weight, for example from about 5 to about 25% by weight, of a plasticiser, preferably apolyhydric alcohol such as glycerol or sorbitol. Cullen, p. 5, ll. 4-28. Appellants do not dispute the finding of the Examiner that Cullen thus teaches all of the limitations of claim 1, but argue that the Examiner does not point to any motivation of obviousness other than that the “instantly claimed compositions are nothing more than a combination of known components used for their known uses to make a known product.” See App. Br. 7. “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’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). However, “there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” Id. at 418. The Examiner has articulated a reason to support the conclusion of obviousness, viz., that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention by selecting from the various elements disclosed by Cullen to achieve the predictable result of producing an effective wound dressing. See Ans. 7. Because Cullen teaches all of the limitations of claim 1, we affirm the Examiner’s rejection of that claim. Claims 2-5, 7, 11-13, 15, and 18 fall with claim 1 because they were not argued separately. 37 C.F.R. § 41.37(c)(1)(vii). Appeal 2012-009664 Application 10/548,231 10 Appellants incorporate by reference their arguments with respect to Cullen in their appeals of the Examiner’s remaining rejections over Watt, Watt GB, and Watt GB and Cullen. See App. Br. 7-8. For the reasons set forth supra, we similarly decline to reverse these rejections. DECISION The Examiner’s rejection of claim 1 under 35 U.S.C. § 112 (second paragraph) is affirmed. The Examiner’s rejection of claims 1-5, 7, 11-13, 15, and 18 under 35 U.S.C. § 103(a) is affirmed. 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 cdc