Ex Parte Ganey

Patent Trials and Appeals BoardJan 8, 2019

14865798 - (D) (P.T.A.B. Jan. 8, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/865,798 09/25/2015 119489 7590 Vivex Biomedical Inc. David L. King 5131 NE County Road 340 High Spring, FL 32643 01/08/2019 FIRST NAMED INVENTOR Timothy Ganey 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. DN0278 1767 EXAMINER DORNBUSCH, DIANNE ART UNIT PAPER NUMBER 3771 MAIL DATE DELIVERY MODE 01/08/2019 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 TIMOTHY GANEY 1 Appeal 2018-002728 Application 14/865,798 Technology Center 3700 Before DANIELS. SONG, WILLIAM A. CAPP, and JILL D. HILL, Administrative Patent Judges. SONG, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE The Appellant appeals under 35 U.S.C. Â§ 134(a) from the Examiner's Final Office Action ("Final Act.") rejecting claims 1, 6-8, and 10 in the present application, the remaining claims having been either withdrawn or canceled (App. Br. 5). We have jurisdiction under 35 U.S.C. Â§Â§ 6(b) and 134(a). We AFFIRM. 1 The Appellant is the Applicant, Vivex Biomedical, Inc., which is identified as the real party in interest (Appeal Brief ("App. Br.") 3). Appeal2018-002728 Application 14/865,798 The claimed invention is directed to a structurally enhanced tissue graft (Abstract). Representative independent claim 1 reads as follows (App. Br. 12, Claims App., formatting added): 1. A freeze-dried structurally enhanced placental tissue graft made from placental tissue comprises: at least one placental tissue membrane formed from a single membrane having a corrugated portion of placental tissue made of a series of pleated peaks and valleys and a lateral flat portion of placental tissue adhered to the corrugated portion to form the structurally enhanced placental tissue graft upon drying, wherein the flat portion when placed in contact to an outer surface along either peaks or valleys of the corrugated portion adheres directly to the corrugated portion[,] wherein the flat portion in combination with the corrugated portion form open channels configured for infusion of blood flow during implantation and the combination of the folded over lateral flat portion and the corrugated portion have the same exposed external surfaces and the channels created by the folded flat portion and the corrugated portion have the same internal surfaces; wherein the exposed external surfaces are an epithelial surface with an exposed jelly-like fibroblast cellular layer; and wherein the structurally enhanced tissue graft has been freeze dried. REJECTION The Examiner rejects claims 1, 6-8, and 10 under 35 U.S.C. Â§ 103 as obvious over Mathisen (US 2014/0222161 Al, pub. Aug. 7, 2014) in view of Koob et al. (US 2014/0067058, pub. Mar. 6, 2014 (hereinafter "Koob")) (Final Act. 2). 2 Appeal2018-002728 Application 14/865,798 ANALYSIS Only those arguments actually made by the Appellant have been considered in this decision. Arguments that the Appellant could have made but chose not to make have not been considered and are deemed to be waived. See 37 C.F.R. Â§ 4I.37(c)(l)(iv); In re Jung, 637 F.3d 1356, 1365- 66 (Fed. Cir. 2011); Ex parte Frye, 94 USPQ2d 1072, 1075-76 (BPAI 2010 (precedential)). The Examiner rejects independent claim 1, finding that Mathisen discloses all of the limitations of the claims except for: "the device being formed of a single membrane;" "the membrane being a placental tissue membrane;" the two layers being "adhered prior to drying;" and the graft being freeze dried. (Final Act. 3). The Examiner finds that Koob "discloses a tissue graft comprising the use of placental tissue membrane to form a graft and that placental membrane is well known in the field as disclosed in [0002]." (Id.; Koob ,r 2 ("[h ]uman placental membrane ( e.g. amniotic membrane) has been used for various types of reconstructive surgical procedures since the early 1900s.")). The Examiner also finds that Koob discloses drying the tissue membrane "on a mandrel or die to form the pleated peaks and valleys," and freeze drying the tissue graft. (Final Act. 4 (citing Koob ,r,r 59-91, Fig. 2)). The Examiner concludes that it would have been obvious to a person of ordinary skill in the art to have made the device of Mathisen from a single membrane because forming a two piece article as one piece involves only routine skill. (Final Act. 3 (citing Howard v. Detroit Stove Works, 150 U.S. 164 (1893))). The Examiner also concludes that it would have been obvious 3 Appeal2018-002728 Application 14/865,798 to a person of ordinary skill in the art to have used placental membrane in Mathisen because "select[ing] a known material on the basis of its suitability for the intended use [i]s a matter of obvious design choice," and "the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination." (Final Act. 3--4). The Examiner further concludes that it would also have been obvious to freeze dry the graft in view of Koob "since the use of the freeze-dryer to dehydrate the tissue grafts can be more efficient and thorough compared to other techniques such as thermal dehydration as well as to minimize formation of porous structures within the tissue graft." (Final Act. 4 ( citing Koob ,r,r 59--91) ). The Examiner further states that claimed phrases pertaining to adhering prior to drying, drying on a mandrel or die to form the pleated peaks and valleys, and freeze drying are product by process limitations. (Final Act. 4). We agree with the Examiner's findings and conclusions of obviousness, and address the Appellant's arguments infra. The Appellant argues that Mathisen discloses "a porous structure to facilitate fluid flow through the porous material," and Koob discloses "a mesh or woven structure to aid in fluid flow." (App. Br. 10). The Appellant draws a distinction as to the claimed invention, stating "the nature of the membrane is such that blood infusion is channeled through the troughs, but the whole blood cells cannot pass across and through the membrane due to the semi-permeable nature of placental tissue," and asserts that "[t ]his is neither taught nor suggested in the cited prior art." (App. Br. 10-11). The Appellant asserts that the Examiner's rejection "completely change[s] the principle of operation of the prior art references, which operate by allowing 4 Appeal2018-002728 Application 14/865,798 whole blood to flow across and through the porous structure." (App. Br. 11). These arguments are unpersuasive for a variety of reasons. First, while Mathisen discloses a "thin porous component" (Mathisen, Abst.), and Koob discloses a "biocompatible mesh" (Koob, Abst.), the Appellant does not establish a basis for its assertion that the prior art devices "operate by allowing whole blood to flow across and through the porous structure." (App. Br. 11 ). The Appellant does not direct us to citations in the applied prior art references in support of its assertion. Second, while the Appellant asserts that placental tissue is "semi-permeable" while Mathisen is "porous," we understand semi-permeable to simply mean that its pores are very small so as to restrict the type of material that can be passed therethrough. Accordingly, a semi-permeable membrane is still porous, such that the distinction being asserted is not substantiated. Finally, while Koob does disclose a biocompatible mesh, it also discloses using placental tissue in conjunction therewith (Koob ,r 59), which would also prevent allowing whole blood to flow therethrough. Therefore, even if there is a distinction between the "porous component" disclosed in Mathisen and the claimed "placental tissue," we agree with the Examiner that the Appellant is arguing that: the qualities that make their device unique ... is due to the natural properties of the placenta. If this is the case, the placental membrane taught by Koob would have the same properties; hence the device of Mathisen in view of Koob would be able to block flow but allow flow through the open channels created by the corrugations for blood infusion. (Ans. 4; see also Ans. 2; Koob ,r 2). 5 Appeal2018-002728 Application 14/865,798 Hence, the Appellant's arguments are unpersuasive and we affirm the Examiner's obviousness rejection of independent claim 1. The Appellant does not submit any separate arguments directed to claims 6-8 and 10 that depend from claim 1. Therefore, these dependent claims fall with claim 1. CONCLUSION The Examiner's rejection of claims 1, 6-8, and 10 is AFFIRMED. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a). See 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED 6