Ex Parte Shah et alDownload PDFPatent Trial and Appeal BoardJan 11, 201611608906 (P.T.A.B. Jan. 11, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 11/608,906 12/11/2006 Faraia Shah 20306 7590 01/11/2016 MCDONNELL BOEHNEN HULBERT & BERGHOFF LLP 300 S. WACKER DRIVE 32NDFLOOR CHICAGO, IL 60606 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. 14-1167-WO-US 1185 EXAMINER TSAY,MARSHAM ART UNIT PAPER NUMBER 1656 MAILDATE DELIVERY MODE 01111/2016 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte F ARAIA SHAH, RACHAEL CLARK, PA TRICK JOHN TROTTER, PAUL WILLIAM WATT, and BREDA MARY CULLEN1 Appeal2013-005476 Application 11/608,906 Technology Center 1600 Before DONALD E. ADAMS, ULRIKE W. JENKS, and TA WEN CHANG, Administrative Patent Judges. CHANG, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to methods of treating mammalian wounds, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b ). We reverse. 1 Appellants identify the Real Party in Interest as Systagenix Wound Management (US), Inc. (Appeal Br. 3.) Appeal2013-005476 Application 11/608,906 STATEMENT OF THE CASE According to the Specification, "[t]here [is] a need ... for the early diagnosis and prognosis of wound infection, and for devices and wound dressings for use in carrying out such methods." (Spec. 2: 1 7-19.) The Specification states that "higher levels of vimentin[, a cytoskeletal component,] ... are present in ... infected fluid than in ... non-infected fluid" and that "[ v ]imentin and associated markers could therefore be used as a diagnostic or prognostic of infection .... " (Id. at 3:24--31, 4: 14--15.) Claims 10-13 and 16 are on appeal. 2 Claim 10 is the only independent claim and reads as follows: 10. A method for the treatment of a mammalian wound comprising the steps of measuring in a wound fluid the presence or level of a marker in a wound fluid collected from the wound, and applying an antimicrobial wound dressing to the wound selectively if the presence or level of said marker is indicative of an infection in the wound, wherein the marker is a cytoskeletal component or a breakdown product thereof, further wherein the marker is indicative of an infection in the wound if the level of the marker is elevated. 2 We note that claim 16 as set forth in the Claims Appendix of the Appeal Brief depends from claim 19, which had been previously withdrawn. We assume that this is a typographical error and that claim 16 depends from claim 10. Compare Reply Pursuant to 37 C.F.R. § 1.111 at3 (Dec. 6, 2011). 2 Appeal2013-005476 Application 11/608,906 The claims stand rejected as follows: Claims 10-13 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Cullen, 3 Raffetto, 4 and Hilfenhaus. 5 Claim 16 is rejected under 35 U.S.C. 103(a) as being unpatentable over Cullen, Raffetto, Hilfenhaus, and Bucala. 6 DISCUSSION Issue The Examiner has rejected claims 10-13 under 35 U.S.C. § 103(a) as being unpatentable over Cullen, Raffetto, and Hilfenhaus. The Examiner finds that Cullen discloses a method of predicting or diagnosing clinical infection of a wound comprising measuring the concentration of a marker associated with an inflammatory response in wound fluid . . . . Cullen discloses [that] examples of markers associated with an inflammatory response include fibronectin and collagen . . . . Cullen discloses that a method of detecting a clinical infection of a wound as early as possible allows for the infection to be treated topically as opposed to having to use 3 Cullen, U.S. Patent No. 7,794,925 B2, issued Sep. 14, 2010. 4 Raffetto et al., Changes in Cellular Motility and Cytoskeletal Actin in Fibroblasts from Patients with Chronic Venous Insufficiency and in Neonatal Fibroblasts in the Presence of Chronic Wound Fluid, 33 J. VASCULAR SURGERY 1233 (2001). 5 Hilfenhaus et al., U.S. Patent No. 7,270,721 B2, issued Sep. 18, 2007. 6 Bucala et al., Circulating Fibrocytes Define a New Leukocyte Subpopulation That Mediates Tissue Repair, 1 MOLECULAR MED. 71 (1994). 3 Appeal2013-005476 Application 11/608,906 antibiotics . . . . Cullen discloses wounds that can be diagnosed for infection can be chronic, i.e. chronic ulcers .... (Ans. 4--5.) The Examiner further finds that "Cullen discloses ... which [concentration] levels [of the markers of the inflammatory response] would reasonably indicate the presence of a clinical infection." (Id. at 7 .) The Examiner finds that Cullen does not teach "the presence or level of [a cytoskeletal protein] in the wound fluid" and does not explicitly teach applying a wound dressing to the wound. (Id. at 5.) However, the Examiner finds that Raffetto discloses a method of measuring[,] in a chronic venous ulcer wound fluid, the presence of cytoskeletal protein a-smooth muscle actin ( a-sma), where an increased level of a-sma was observed in samples obtained from ulcer patients compared with samples from patients with chronic venous insufficiency (CVI) but no ulcers present . . . . [Raffetto] further suggest[ s] that a-sma can be quantified by W estem blot analysis . . . . [Raffetto] disclose[ s] that a-sma is present in fibroblasts of wounded tissue ... but not present in tissues with no ulcerations present . . . . In addition to a-sma, [Raffetto] also disclose[ s] that collagen and fibronectin proteins are also produced in wounded tissue (Id. 5.) The Examiner further finds that Hilfenhaus discloses that "an antimicrobial wound dressing can be applied for treating skin wounds." (Id.) The Examiner concludes that it would have been obvious to a skilled artisan to modify Cullen's method by using the level of cytoskeletal protein disclosed in Raffetto (i.e., the level of a-sma) as an indicator for infection and further to apply Hilfenhaus' antimicrobial wound dressing where an elevated level of a-sma indicates an infection. (Id. at 5---6.) The Examiner finds that Raffetto provides the motivation to modify Cullen's method as 4 Appeal2013-005476 Application 11/608,906 described, because Raff etto discloses that "an elevated level of a-sma [in] a wound fluid is indicative of a pathological condition, i.e., an ulcer" and Cullen and Hilfenhaus teach that "protein markers expressed in wounded tissue and/ or associated with an inflammatory response in a wound fluid can be used to diagnose wound infections," which can be "treated topically with an antimicrobial wound dressing." (Id. at 6-7; see also id. at 21, 24.) With respect to claim 16, the Examiner additionally relies on Bucala for disclosing "a method of measuring in a wound fluid the presence of vimentin" and for disclosing vimentin as "positively expressed in ... fibroblast-like cell found at sites of tissue injury." (Id. at 8.) The Examiner concludes that it would have been obvious to a skilled artisan to modify Cullen's method in view of Raffetto and Hilfenhaus, "by substituting the step of measuring [Bucala's] vimentin ... for the step of measuring [the] a- sma of Raffetto." (Id.) The Examiner concludes that Bucala would have provided the motivation to make such a modification, because it discloses that vimentin, which is also a cytoskeletal protein like a-sma, is positively expressed by fibroblasts at wound sites. (Id.) Appellants contend that the cited references do not suggest the claimed step of "measuring in a wound fluid the presence or level of a marker ... wherein the marker is a cytoskeletal component or breakdown product thereof, further wherein the marker is indicative of an infection in the wound if the level of the marker is elevated." (Appeal Br. 6.) Among other things, Appellants argue that none of the cited references suggests that cytoskeletal components (such as a-sma and vimentin) may be an infection indicator, much less that different wound dressing should be applied 5 Appeal2013-005476 Application 11/608,906 depending on the level of cytoskeletal components. (Id. at 6-8, 11-12.) Appellants further contend that, because the cited art provide no correlation between the markers of infection disclosed in Cullen and any cytoskeletal component, a skilled artisan would have neither motivation nor reasonable expectation of success by modifying Cullen's method to use a cytoskeletal component as the infection marker. (Id. at 8, 11-12.) The issue with respect to this rejection is whether it would have been obvious to modify Cullen's method of predicting or diagnosing infections by measuring the level of a cytoskeletal component or breakdown product, such as the a-sma disclosed in Raffetto or the vimentin disclosed in Bucala. Analysis On balance, we agree with Appellants that Examiner has not established a prima facie case for obviousness. A rejection for obviousness must include "articulated reasoning with some rational underpinning to support the legal conclusion." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (quoting In re Kahn, 441F.3d977, 988 (Fed. Cir. 2006)). In this case, the Examiner has not sufficiently articulated a reason to modify Cullen's method of predicting or diagnosing infection by measuring the level of the cytoskeletal components disclosed in Raff etto ( a-sma) and Bucala (vimentin). Cullen teaches using certain structural proteins associated with inflammatory response to diagnose or predict infection, but does not disclose using a-sma and vimentin to predict infection. While Raffetto and Bucala disclose that a-sma and vimentin may be present in the wound environment and/or associated with certain pathological conditions 6 Appeal2013-005476 Application 11/608,906 such as ulcers (Ans. 5-6, 8), the Examiner has not provided a sufficient evidentiary basis to support a conclusion that all structural proteins present in wound environments are markers associated with an inflammatory response. Similarly, the Examiner does not explain why the mere presence or increased level of proteins such as a-sma or vimentin in wound fluid would suggest to a skilled artisan that these components would be useful as a marker for predicting or diagnosing infection, given that not all wounds or ulcers become infected. Accordingly, we reverse the Examiner's rejection of claims 10-13 under 35 U.S.C. § 103(a) as being unpatentable over Cullen, Raffetto, and Hilfenhaus. We also reverse the Examiner's rejection of claim 16 under 35 U.S.C. § 103(a) as being unpatentable over Cullen, Raffetto, Hilfenhaus, and Bucala. SUMMARY We reverse the rejection of claims 10-13 as obvious over Cullen, Raffetto, and Hilfenhaus. We also reverse the rejection of claim 16 as obvious over Cullen, Raffetto, Hilfenhaus, and Bucala. REVERSED kmm 7 Copy with citationCopy as parenthetical citation