Ex Parte Corley

Patent Trial and Appeal BoardAug 16, 2017

13290283 (P.T.A.B. Aug. 16, 2017)

United States Patent and Trademark Office 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 13/290,283 11/07/2011 Kevin M. Corley H-KN-01854US/1253-023US01 9920 149863 7590 08/18/2017 CARDINAL HEALTH INC. ATTN: DANIEL C. STELTER 300 South Riverside Plaza Suite 2010 Chicago, IL 60606 EXAMINER CARREIRO, CAITLIN ANN ART UNIT PAPER NUMBER 3772 NOTIFICATION DATE DELIVERY MODE 08/18/2017 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): C AH @ cardinal-ip. com karen.dangelo @ cardinalhealth.com patent@cardinalhealth.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KEVIN M. CORLEY Appeal 2016-001911 Application 13/290,283 Technology Center 3700 Before LYNNE H. BROWNE, ERIC C. JESCHKE, and PAUL J. KORNICZKY, Administrative Patent Judges. BROWNE, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Kevin M. Corley (Appellant) appeals under 35 U.S.C. § 134 from the rejection of claims 1—9 and 11—20. We have jurisdiction under 35 U.S.C. § 6(b). We reverse and enter new grounds of rejection pursuant to our authority under 37 C.F.R. § 41.50(b). Appeal 2016-001911 Application 13/290,283 CLAIMED SUBJECT MATTER The claims are directed to an absorbent foam tape and related methods thereof. Spec. 11. Claims 1 and 9 are independent. Claim 1 reproduced below, is illustrative of the claimed subject matter: 1. A method of preparing a wound dressing, comprising providing a tape comprising a foam layer having a first surface and an opposite surface, an adhesive layer disposed in a predetermined adhesive pattern on at least a portion of the first surface of the foam layer, a breathable layer disposed on at least a portion of the opposite surface of the foam layer, and a release layer disposed on the breathable layer. REFERENCES The prior art relied upon in this decision on appeal is: Edenbaum Cilento Hilston Areskoug Cassel US 4,733,659 US 4,773,409 US 6,077,986 US 6,486,378 B1 US 2005/0255150 A1 Mar. 29, 1988 Sept. 27, 1988 June 20, 2000 Nov. 26, 2002 Nov. 17, 2005 REJECTIONS I. Claims 1—3, 5—9, 11, 12, and 14—16 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Areskoug and Hilston. II. Claims 4 and 13 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Areskoug, Hilston, and Cilento. III. Claims 17—20 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Areskoug, Hilston, and Edenbaum. IV. Claims 1, 3—9, 11—13, 15, and 16 are rejected under 35 U.S.C. § 103(a) as unpatentable over Areskoug and Cassel.1 1 This is a new ground of rejection discussed infra. 2 Appeal 2016-001911 Application 13/290,283 V. Claim 2 is rejected under 35 U.S.C. § 103(a) as unpatentable over Areskoug, Cassel, and Hilston.2 DISCUSSION Rejection I Claims 1—3 and 5—8 The Examiner finds that Areskoug discloses all of the limitations of claim 1 except for “a release layer is disposed on the breathable layer.” Final Act. 3. The Examiner further finds that Hilston “discloses a structurally similar foam dressing device which includes a release layer 42 used to protect areas of the dressing from contamination prior to use.” Id. Based on these findings, the Examiner determines that it would have been obvious to modify the device of Areskoug to include a release liner such as the release layer 42 of Hilston that is disposed on at least a portion of a breathable layer in order to protect this layer from environmental contaminants prior to use and also to prevent the dressing from absorbing moisture prior to use. Id. Allowing “that even if one having ordinary skill in the art would have understood the upper layer 2 of Areskoug to be a breathable layer, which Appellant does not concede,” Appellant contends that “the motivation relied upon by the Examiner would not have caused one of ordinary skill in the art to modify the Areskoug dressing by disposing the release layer 42 of Hilston on the absorbent material of upper layer 2 of the Areskoug dressing.” Appeal Br. 7 (emphasis omitted). In support of this contention, Appellant argues that “[t]he Examiner has not explained why one of ordinary skill in 2 See n. 1. 3 Appeal 2016-001911 Application 13/290,283 the art would have looked to the release layer 42 disclosed by Hilston, onto which adhesive 43 is disposed.” Id. Rather, Appellant asserts, one skilled in the art “would have modified the Areskoug dressing to dispose the release layer 42 disclosed by Hilston on the adhesive coating. However, this modification of Areskoug in view of Hilston would still fail to arrive at the claimed feature of a release layer disposed on a breathable layer.” Id. at 8 (emphasis omitted). Responding to these arguments, the Examiner finds that in the case of a breathable layer such as the foam layer of Areskoug, it is well known that such materials absorb moisture when exposed even to humidity in open air environments and, therefore, it is known in the art to prevent exposure of these material to moisture prior to use. Ans. 13. The Examiner further finds that one skilled in the art “would understand that it is imperative to maintain sterility of a wound dressing such as that of Areskoug and that wrappers, packages, protective coverings, and releasable liners and sheets are commonly used in the art to shield such surfaces from environmental contaminants to maintain sterility.” Id. In addition, the Examiner finds that “the Hilston reference explicitly teaches that the release layer 42 is covering the adhesive surface of foam 44, which is ‘permeable to air by perforation.’” Id. (citing Hilston 7:61—65). Based on this finding, the Examiner determines that Hilston “discloses use of the release layer to cover a ‘breathable’ layer which is not unlike the gauze forming upper layer 2 in Areskoug.” Id. However, Hilston indicates that the liner backing, not the release layer, protects its foam and adhesive layers. See, e.g., Hilston 2:51—53 (describing the use of a liner having a release layer to protect the foam and adhesive from exposure to the casting apparatus). Furthermore, we agree 4 Appeal 2016-001911 Application 13/290,283 with Appellants that, to the extent Hilston suggests the use of a release layer, it suggests use of a release layer covering an adhesive layer. See Appeal Br. 7. In addition, even if Hilston’s adhesive layer can fairly be considered a breathable layer, Hilston’s adhesive layer, in the context of the claimed invention, corresponds to the claimed adhesive layer, not the claimed breathable layer. Accordingly, we agree with Appellant that applying Hilston’s teachings to Areskoug’s device would not result in the claimed invention. Id. For these reasons, the Examiner’s articulated reasoning lacks rational underpinning. Accordingly, we do not sustain the Examiner’s decision rejecting claim 1, and claims 2, 3, and 5—8, which depend therefrom. Claims 9. 11. 12. and 14-16 In rejecting claim 9, the Examiner relies upon similar reasoning in support of the modification of Areskoug in view of Hilston. See Final Act. 8. This reasoning lacks rational underpinning for the reasons discussed supra. Accordingly, we do not sustain the Examiner’s decision rejecting claim 9, and claims 11, 12, and 14—16, which depend therefrom. Rejections II and III Claims 4, 13, and 17—20 depend from either claim 1 or claim 9. Appeal Br. 18, 20, 21, Claims App. Accordingly, the rejection of claims 4 and 13 (Rejection II) and claims 17—20 (Rejection III) rely on the same reasoning as the rejection of claims 1 and 9. This reasoning lacks rational underpinning for the reasons discussed supra. Accordingly, we do not sustain the Examiner’s decisions rejection claims 4, 13, and 17—20. 5 Appeal 2016-001911 Application 13/290,283 First New Ground of Rejection Claims 1, 3—9, 11—13, 15, and 16 are rejected under 35 U.S.C. § 103(a) as unpatentable over Areskoug and Cassel.3 Claim 1 We adopt the Examiner’s findings pertaining to Areskoug as our own. See Final Act. 3. We note that Areskoug’s “upper layer 24 is comprised of an absorbent material that is able to drain the bottom layer 3.” Areskoug 2:24—25. We further note that although Areskoug’s “invention relates to a wound dressing,” Areskoug does not address the need to keep such dressings sterile. Id. at 1:6. However, those skilled in the art would be aware of the need to keep such dressings sterile prior to their use in order to reduce the possibility of contamination. Further, those skilled in the art would understand that it is just as important to keep Areskoug’s upper layer 2 sterile as it is to keep Areskoug’s foam layer 3 sterile because of the absorbent nature of Areskoug’s upper layer 2. Cassel discloses a wound treatment patch 10 including a release layer. Cassel 1119. Cassel teaches that “[rjelease liners prevent release of the active components during patch storage and maintain sterility after the patch is removed from its package.” Id. One skilled in the art reading this portion of Cassel would understand that release liners can be used to maintain sterility. In view of these findings and reasoning, one skilled in the art at the time of the invention considering both Areskoug and Cassel would have 3 We note that the Examiner identified Cassel as illustrating the use of liners in the Advisory Action dated January 13, 2015. Adv. Act. 2. 4 Identified in the Examiner’s findings as corresponding to the claimed breathable layer. 6 Appeal 2016-001911 Application 13/290,283 concluded that it would be obvious to use a release layer on both sides of Areskoug’s wound dressing in order to maintain the sterility of the wound dressing prior to use. Such modification renders the subject matter of claim 1 unpatentable over Areskoug and Cassel. Claim 3 Areskoug states that “layer 3 is comprised of an hydrophilic polyurethane foam having open cells.” Areskoug 2:11—12. Cassel discloses release liners comprised of “a sterile, impermeable flexible material that is easily removed.” Cassel 1119. Cassel states that “[sjuitable release liners are readily commercially available. Suitable release liners include, but are not limited to, occlusive, opaque, or clear polyester films with a thin coating of pressure sensitive release liner (e.g., siliconefluorsilicone, and perfluorcarbon based polymers).” Id. Thus, the modified device would have a “foam layer [that] is comprised of polyurethane with open cells” and a release layer comprised of a silicone compound, as recited in claim 3. Claim 4 Areskoug does not disclose introducing at least one therapeutic agent in the foam layer. See, generally, Areskoug. However, Cassel teaches the inclusion of therapeutic agents such as opioids in the absorbent foam layer of its patch to treat pain. See, e.g., Cassell Abstr. In view of this teaching, one skilled in the art considering Areskoug and Cassel at the time of the invention would have found it obvious to include a therapeutic agent in absorbent foam layer of Areskoug’s wound dressing to treat pain, as recited in claim 4. Claim 5 As recited in claim 5, Areskoug discloses an adhesive layer in a discontinuous adhesive pattern as shown in Figure 1A. See Final Act. 5. 7 Appeal 2016-001911 Application 13/290,283 Claim 6 As recited in claim 6, Areskoug discloses an adhesive layer made of silicone gel. Areskoug 2:15. Claim 7 As discussed supra, Areskoug does not address sterilization of its wound dressing. However, as explained supra regarding claim 1, one skilled in the art at the time of the invention would have been well aware of the need to sterilize a wound dressing in order to prevent contamination prior to use, as recited in claim 7. Claim 8 As discussed supra regarding claim 3, Cassel discloses a release layer made of a silicone compound, as recited in claim 8. Cassel 1119. Claim 9 As discussed supra regarding claim 1, Areskoug and Cassel disclose an absorbent foam layer, an adhesive layer, a breathable layer, and a release layer, as recited in claim 9. Claim 11 As discussed supra regarding claim 3, Areskoug discloses an absorbent foam layer comprising an hydrophilic polyurethane foam, as recited in claim 11. Areskoug 2:11—12. Claim 12 As discussed supra regarding claims 3 and 8, Cassel discloses a release layer made of a silicone compound, as recited in claim 12. Cassel 1119. Claim 13 As discussed supra regarding claim 4, Cassel teaches use of a therapeutic agent in the absorbent foam layer, as recited in claim 13. 8 Appeal 2016-001911 Application 13/290,283 Claim 15 As discussed supra regarding claim 6, Areskoug discloses an adhesive layer made of silicone gel, as recited in claim 15. Areskoug 2:15. Claim 16 Areskoug discloses a foam layer having a preferable thickness of 1—2 mm with a maximum thickness of 2 mm. Areskoug 2:65—67, 1:49—50. Areskoug does not explicitly state the thickness of its other layers. See generally, Areskoug. However, these layers are shown relative to one another in Areskoug’s Figure 1. From this figure one skilled in the art would conclude that Areskoug’s wound dressing has a thickness of approximately 4—5 mm or about 0.16-0.2 inches5 which is within the range recited in claim 16. Thus, even if Areskoug does not explicitly disclose the claimed range, it suggests a wound dressing having a thickness within this range to those skilled in the art. Second New Ground of Rejection Claim 2 is rejected under 35 U.S.C. § 103(a) as unpatentable over Areskoug, Cassel, and Hilston. Neither Areskoug nor Cassel disclose a method comprising the step of “wrapping at least a portion of the tape around a core to produce a foam roll” as required by claim 2. Appeal Br. 18, Claims App. Hilston teaches winding a tape for use as “a bandage or wound dressing” on a roll. Appeal Br. 1:20-21, 3—3. We adopt as our own the Examiner’s reasoning that such 5 We note that in this case, although the drawings are not to scale, Areskoug discloses the dimensions for one of the features (i.e., layer 3) shown. Areskoug 2:65—67. In such instances, the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art. In re Wright, 569 F.2d 1124, 1127 (CCPA 1977). 9 Appeal 2016-001911 Application 13/290,283 rolls “provide convenient packaging of the tape for storage until use.” Final Act. 4. Based on this reasoning, we conclude that one skilled in the art would have found it obvious to wrap Areskoug’s wound dressing as modified in view of Cassel around a core to produce a foam roll. Thus, the combined teachings of Areskoug, Cassel, and Hilston render claim 2 unpatentable. DECISION The Examiner’s rejections of claims 1—9 and 11—20 are REVERSED. We enter NEW GROUNDS OF REJECTION of claims 1-9, 11-13, 15, and 16 under 35 U.S.C. § 103. This decision contains new grounds of rejection pursuant to 37 C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” Section 41.50(b) also provides: When the Board enters such a non-final decision, the Appellant, within two months from the date of the decision, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the prosecution will be remanded to the examiner. The new ground of rejection is binding upon the examiner unless an amendment or new Evidence not previously of Record is made which, in the opinion of the examiner, overcomes the new ground of rejection designated in the decision. Should the examiner reject the claims, appellant may again appeal to the Board pursuant to this subpart. (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same Record. The request 10 Appeal 2016-001911 Application 13/290,283 for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of rejection and also state all other grounds upon which rehearing is sought. Further guidance on responding to a new ground of rejection can found in the Manual of Patent Examining Procedure § 1214.01. REVERSED; 37 C.F.R, $ 41.50(b)