Ex Parte Lee et alDownload PDFPatent Trials and Appeals BoardJun 5, 201912601518 - (D) (P.T.A.B. Jun. 5, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/601,518 11/23/2009 26530 7590 06/07/2019 LADAS & PARRY LLP 224 SOUTH MICHIGAN A VENUE SUITE 1600 CHICAGO, IL 60604 FIRST NAMED INVENTOR Heeyoung Lee 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. CU-9893 8136 EXAMINER PYLA, EVELYN Y ART UNIT PAPER NUMBER 1651 NOTIFICATION DATE DELIVERY MODE 06/07/2019 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): ChicagoUSPTO@ladas.net PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte HEEYOUNG LEE, HYUNJIN YANG, JUN SEOK LEE, and JI SUK CHOI1 Appeal 12/601,518 Application 2018-007 633 Technology Center 1600 Before DONALD E. ADAMS, ERIC B. GRIMES, and ELIZABETH A. LA VIER, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a method for preparing a scaffold for transplanting fat tissue, 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 Heeyoung Lee. Appeal Br. 3. Appeal2018-007633 Application 12/601,518 STATEMENT OF THE CASE Claims 17-30 are on appeal. Claim 17 is illustrative and reads as follows ( emphasis added): 17. A method for preparing a scaffold for transplantation of fat tissue for the correction of contour deformities in the skin and/or regeneration of deformed sites throughout the human body or cell culture, the method comprising the steps of: (a) fragmenting fat tissue by physical treatments without using any chemical treatment to obtain isolated lipids in a liquid state, a first fragmented fat tissue containing lipids in a liquid state, and a second fragmented fat tissue free of lipids in a liquid state; (b) removing the isolated lipids in a liquid state; ( c) removing only the first fragmented fat tissue containing lipids in a liquid state to isolate the second fragmented fat tissue free of lipids in a liquid state; and ( d) sterilizing the second fragmented fat tissue to obtain a scaffold, wherein a volume and a three-dimensional structure of the scaffold are partially maintained, and wherein a microstructure of the scaffold comprising connective tissue is partially maintained. Claims 18, 24, and 25 are also independent and are directed to methods similar to that of claim 1 7. The differences from claim 1 7 are as follows: claim 18 recites "fragmenting fat tissue by sonication or high pressure nozzle spray," claim 24 recites "fragmenting fat tissue by physical treatments ... to obtain isolated lipid droplets in a liquid state," and claim 25 recites "fragmenting fat tissue by sonication or high pressure nozzle spray to obtain isolated lipid droplets in a liquid state." Appeal Br. 17-19 ( emphases added). 2 Appeal2018-007633 Application 12/601,518 The claims stand rejected as follows: Claims 17-19, 21-26, and 28-302 under 35 U.S.C. § 103(a) as obvious based on Zocchi3 and Chu4 (Ans. 3) and Claims 20 and 27 under 35 U.S.C. § 103(a) as obvious based on Zocchi, Chu, and Simpson5 (Ans. 9). DISCUSSION The Examiner has rejected claims 17-19, 21-26, and 28-306 as obvious based on Zocchi and Chu. The Examiner has rejected claims 20 and 27 as obvious based on Zocchi, Chu, and Simpson. The same issue is dispositive for both rejections. The Examiner finds that Zocchi teaches most of the limitations of the claimed method but does not teach a step of sterilizing its collagen scaffold. Ans. 5-6. The Examiner finds that Chu teaches "methods of sterilizing dermal fillers and injectable collagen" to reduce contamination, and concludes that it would have been obvious to modify Zocchi' s method to include Chu's sterilization step. Id. at 6-7. 2 The statement of the rejection does not include claim 29, but claim 29 is expressly addressed in the body of the rejection. Ans. 8. Thus, we conclude that the omission of claim 29 from the statement of the rejection was a typographical error. 3 Zocchi, EP 0418979 A2, published Mar. 27, 1991. 4 Chu et al., US 7,902,145 B2, issued Mar. 8, 2011. 5 Simpson et al., US 7,615,373 B2, issued Nov. 10, 2009. 6 The statement of the rejection does not include claim 29, but claim 29 is expressly addressed in the body of the rejection. Ans. 8. Thus, we conclude that the omission of claim 29 from the statement of the rejection was a typographical error. 3 Appeal2018-007633 Application 12/601,518 With respect to the three components recited in the claims ("isolated lipids in a liquid state, a first fragmented fat tissue containing lipids in a liquid state, and a second fragmented fat tissue free of lipids in a liquid state"), the Examiner finds that Zocchi's centrifugation step produces different layers that meet those limitations. See id. at 4-6. Specifically, the Examiner finds that the method disclosed by Zoochi [sic] produces three distinct layers. The surface layer, i.e. uppermost layer, is the less dense oily layer comprising fat/oil components such as the liquid lipids released from burst adipocytes and fragmented lipid matrix, which is separated from the middle layer. The oily/fat layer reads on "isolated lipids in a liquid state" and ''first fragmented fat tissue containing lipids in a liquid state". Id. at 6. Appellants argue that Zocchi obtains a middle layer, comprising cellular residues (the wall of the burst adipocytes and intercellular substances) without an uppermost layer and a lower part. However, the middle layer comprises a lipidic matrix containing lipids in a liquid state and a lipid matrix free of lipids in a liquid state. Thus, Zocchi fails to disclose only obtaining a lipid matrix free of lipids in a liquid state without obtaining a lipidic matrix containing a lipid matrix in a liquid state in the middle layer. Appeal Br. 14. "[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case ofunpatentability." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). "In rejecting an application, factual determinations by the PTO must be based on a preponderance of the evidence." In re Oetiker, 977 F.2d 1443, 1449 (Fed. Cir. 1992) (J. Plager, concurring). "What the prior art teaches ... is a 4 Appeal2018-007633 Application 12/601,518 determination of fact." Para-Ordnance Mfg., Inc. v. SGS Importers Int'!, Inc., 73 F.3d 1085, 1088 (Fed. Cir. 1995). Thus, the issue presented is whether a preponderance of the evidence supports the Examiner's finding that Zocchi discloses a method that includes a step of "removing only the first fragmented fat tissue containing lipids in a liquid state to isolate the second fragmented fat tissue free of lipids in a liquid state"-that is, a step of separating fragmented fat tissue containing liquid lipids from fragmented fat tissue free of liquid lipids-as required by the claims on appeal. We conclude that a preponderance of the evidence does not support the Examiner's finding. Zocchi discloses a method "for producing collagen without removing the treated tissues from the harvesting syringes used for the harvesting allowing in this way to complete the whole procedure in a sealed sterile cycle." Zocchi 1:10-14. Zocchi's method comprises "harvesting of fat tissue from the patient with the use of aspirating syringes, subjecting the syringes containing the harvested material to ultrasonic energy until the thorough and complete destruction of the fat cells is accomplished, and separating the resultant material in the syringe in a centrifuge." Id. at 2: 17-23. Zocchi teaches that, after centrifugation, it is possible [to] distinguish in the syringes, from below to high, three different layers; 1) in the lower part the blood, the physiological saline and anaesthetic solution used for the harvesting and the rinsing; 2) in the middle, the auto-collagen formed by all cellular residues, the wall of the burst adipocytes and intercellular substances, very isolated; 3) on the surface, a very important oily layer coming from the lipidic matrix of the burst cells. 5 Appeal2018-007633 Application 12/601,518 Id. at 2:25-36. Zocchi teaches that "only the middle layer, formed by the autologous collagen[,] interests us for the reinjection. It is very simple by a needle to remove all parasitic [sic] layers and so to obtain in all syringes a pure collagen substance." Id. at 2:37-41. Thus, Zocchi teaches that the oil from the burst cells-"isolated lipids in a liquid state," in the language of the claims-forms the top layer in its syringes and can be removed using a needle. Zocchi also teaches that the blood, physiological saline, and anaesthetic solution form the bottom layer in its syringes, and can also be removed using a needle. Zocchi teaches that the middle layer in its syringes contains "auto- collagen [ sic, autologous collagen?] formed by all cellular residues [ and] the wall of the burst adipocytes." Zocchi 2:31-33 (emphasis added). This teaching would seem to contradict the Examiner's finding that Zocchi's oily layer also contains "fragmented lipid matrix" or in the claims' words, "first fragmented fat tissue containing lipids in a liquid state." Ans. 6. Zocchi also teaches that its middle layer is "formed by the autologous collagen" and that removal of the other layers yields "a pure collagen substance." Zocchi 2:37-41. Zocchi thus teaches that its process yields all of the oil from the fat cells in the upper layer and all of the cellular residues and collagen in the middle layer. Zocchi does not disclose the presence of, or any need to remove, "fragmented fat tissue containing lipids in a liquid state" (claims 17, 18, 24, and 25) in its process. We therefore conclude that the Examiner's finding that Zocchi discloses a process that includes a step of "removing only the first fragmented fat tissue containing lipids in a liquid state to isolate the second 6 Appeal2018-007633 Application 12/601,518 fragmented fat tissue free of lipids in a liquid state," as required by the claims, is not supported by a preponderance of the evidence. The Examiner responded to Appellants' argument on this point by reiterating her position that Zocchi's "oily layer would include the less dense fatty/oily portions of the lipoaspirate tissue including lipids released from the cells (free-lipids) and portions of the lipid matrix also released from the burst cells, which would have been fragmented by the application of ultrasonic cavitation." Ans. 11. For the reasons discussed above, however, we conclude that the Examiner's finding on this point is not adequately supported by the evidence. SUMMARY We reverse both of the rejections on appeal. REVERSED 7 Copy with citationCopy as parenthetical citation