10361450 (B.P.A.I. Jan. 20, 2012)

Ex Parte Laurent-Applegate et al

Board of Patent Appeals and InterferencesJan 20, 2012

10361450 (B.P.A.I. Jan. 20, 2012)

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. 10/361,450 02/10/2003 Lee Laurent-Applegate 27894-501 3356 30623 7590 01/23/2012 MINTZ, LEVIN, COHN, FERRIS, GLOVSKY AND POPEO, P.C ONE FINANCIAL CENTER BOSTON, MA 02111 EXAMINER SINGH, SATYENDRA K ART UNIT PAPER NUMBER 1657 MAIL DATE DELIVERY MODE 01/23/2012 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 BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte LEE LAURENT-APPLEGATE and PATRICK HOHLFELD __________ Appeal 2010-010627 Application 10/361,450 Technology Center 1600 __________ Before TONI R. SCHEINER, ERIC GRIMES, and STEPHEN WALSH, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method of treating a skin condition, which the Examiner has rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE Claims 87, 91-102, and 124-140 are on appeal. Claim 87 is representative and reads as follows: Appeal 2010-010627 Application 10/361,450 2 87. A method for treating a skin condition, disorder or disease in a human suffering from said skin condition, disorder or disease, the method comprising cutaneously administering a composition comprising one or more undifferentiated human fetal skin cells integrated with a collagen matrix to form a three-dimensional cutaneous tissue allograft construct or integrated with a carrier suitable for topical administration, wherein the undifferentiated human fetal skin cells are obtained from a single human organ donation, and wherein said human donor tissue is of 12-16 weeks gestation, to an affected area of the human’s skin, wherein the composition is formulated for cutaneous administration and does not result in scar formation upon said cutaneous administration. The Examiner has rejected claims 87, 91-95, 124-129, and 137-140 under 35 U.S.C. § 103(a) as obvious based on Naughton,1 Fauza,2 Bianchini,3 and Southwood4 (Answer 4). The Examiner has also rejected all of the claims on appeal as obvious based on these same references plus six others (Answer 10). The same issue is dispositive with respect to both rejections. The Examiner finds that “Naughton et al teach a method for treating a skin condition . . . [by] administering a composition containing skin cells, or fetal fibroblast[s] integrated with a stromal support matrix containing collagen” (Answer 5) but does not teach the use of undifferentiated fetal skin 1 Naughton et al., US 5,512,475, Apr. 30, 1996 2 Dario O. Fauza et al., Videofetoscopically Assisted Fetal Tissue Engineering: Skin Replacement, 33 J. OF PEDIATRIC SURGERY 357-361 (1998) 3 Pietro Bianchini et al., Immunological Safety Evaluation of a Horse collagen Haemostatic Pad, 51 J. ARZNEIM-FORSCH/DRUG RES. 414-419 (2001) 4 Louise L. Southwood, et al., Instrument Sterilization, Skin Preparation, and Wound Management, 12 VETERINARY CLINICS OF NORTH AMERICA: EQUINE PRACTICE 173-194 (1996) Appeal 2010-010627 Application 10/361,450 3 cells (id. at 6). The Examiner finds that Fauza discloses that “undifferentiated fetal skin cells are obtained . . . from a donor tissue at 90- 95 days of gestation (i.e. between 12 and 16 weeks of gestation), isolated and expanded using in vitro culture system, seeded (using isolated dermal fibroblasts and keratinocytes) on a biocompatible/biodegradable scaffold, cultured, and finally used for transplantation” (id. at 6-7). The Examiner concludes that “it would have been obvious . . . to substitute the fetal cell line used by Naughton et al with the undifferentiated fetal skin cells obtained at a 90-95 days of gestational age (i.e. 12-16 weeks of gestation) used by Fauza et al (i.e. a better art-recognized functional equivalent)” (id. at 8). The Examiner cites Bianchini only for its disclosure of horse collagen (Answer 7) and cites Southwood only for its disclosure of treating veterinary wounds (Answer 8), which are not relevant to claim 87. Appellants argue that “[i]n contrast to the Examiner’s assertion . . . , Fauza does not teach undifferentiated fetal skin cells but rather teaches obtaining epidermal and dermal layers of fetal skin, isolating the dermal fibroblasts and keratinocytes, and culturing these cells separately” (Appeal Br. 8), and none of the other cited references provide any additional teachings with respect to fetal skin cells (Appeal Br. 11, Reply Br. 5). We agree with Appellants that the Examiner has not adequately shown that it would have been obvious to use undifferentiated fetal skin cells in Naughton’s method. As the Examiner has noted (Answer 5), the Specification states that “[t]he term ‘undifferentiated’ is used herein to describe an immature or primitive cell. For example, undifferentiated fetal skin cells include those that can differentiate into dermal fibroblasts and Appeal 2010-010627 Application 10/361,450 4 epidermal keratinocytes.” (Spec. 14: 12-14.) Thus, fibroblasts and keratinocytes are differentiated cells, even though undifferentiated fetal skin cells can differentiate into these types of cells. Fauza discloses that fetal skin specimens were harvested from fetal lambs and “[f]etal keratinocytes and dermal fibroblasts were then separately cultivated and expanded in vitro” (Fauza 357, “Methods”). After culturing, “the dermal fibroblasts were seeded on a . . . polyglycolic acid polymer scaffold. . . . Three days later, the keratinocytes were seeded on the same polymer, over the dermal fibroblasts.” (Id. at 358, right col.) The resulting “autologous-engineered skin was implanted” over a skin defect in a newborn lamb (id.). We agree with Appellants that Fauza does not disclose a method that uses undifferentiated fetal skin cells. Rather, its method uses differentiated fetal fibroblasts and keratinocytes. The Examiner argues that the claim language should be interpreted as “encompassing any fetal skin cells that have the capability to give rise to dermal fibroblasts or epidermal keratinocytes, as long as they have been obtained from the donor tissue at a gestational age of 12-16 weeks” (Answer 5). This interpretation, however, does not support a finding that Fauza discloses undifferentiated fetal skin cells. Fauza’s cells are not “fetal skin cells that have the capability to give rise to dermal fibroblasts or epidermal keratinocytes,” in the Examiner’s words; they are cells that have already differentiated into fibroblasts or keratinocytes. Differentiated cells are not undifferentiated. Appeal 2010-010627 Application 10/361,450 5 The Examiner has not pointed to any disclosure of undifferentiated fetal skin cells in Bianchini, Southwood, or any of the six additional references cited in the second ground of rejection (see Answer 7-8, 10-11). SUMMARY We reverse both of the rejections on appeal. REVERSED lp