Kibalo, Benjamin T.Download PDFPatent Trials and Appeals BoardDec 27, 201914676289 - (D) (P.T.A.B. Dec. 27, 2019) Copy Citation 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. 14/676,289 04/01/2015 Benjamin T. Kibalo 128196-05702 1032 145655 7590 12/27/2019 McCarter & English, LLP/LifeCell 265 Franklin Street Boston, MA 02110 EXAMINER KIPOUROS, HOLLY MICHAELA ART UNIT PAPER NUMBER 1799 NOTIFICATION DATE DELIVERY MODE 12/27/2019 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): docket@mccarter.com mvaneman@mccarter.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BENJAMIN T. KIBALO Appeal 2019–003943 Application 14/676,289 Technology Center 1700 Before MONTÉ T. SQUIRE, AVELYN M. ROSS, and BRIAN D. RANGE, Administrative Patent Judges. RANGE, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant appeals from the Examiner’s decision to reject claims 59–70, 72, and 74.1 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as LifeCell Corporation. Appeal Br. 1. Appeal 2019–003943 Application 14/676,289 2 CLAIMED SUBJECT MATTER2 Appellant describes the invention as relating to processing of human or animal tissue for patient issue. Spec. ¶ 2. In particular, tissues are processed to remove certain components or destroy pathogens while maintaining desired biologic properties of the tissue. Id. ¶¶ 2, 23. Claim 59 is the only independent claim on appeal and is illustrative of the claimed subject matter: 59. A method for reducing the bioburden in a soft tissue sample, said method comprising: providing a tissue comprising mammalian skin; removing an epidermal layer from the skin; and applying a sustained pressure to the tissue by placing the tissue in a liquid and applying sustained elevated pressure to the liquid for a time sufficient to cause at least a 5 log reduction in the bacterial concentration within the tissue, wherein the pressure is applied at a rate to control the temperature of the tissue such that the temperature of the tissue does not exceed 30°C. Appeal Br. 13 (Claims App.) (emphasis added to certain key recitations). 2 In this Decision, we refer to the Final Office Action mailed May 1, 2018 (“Final Act.”), the Appeal Brief filed October 29, 2018 (“Appeal Br.”), the Examiner’s Answer mailed February 25, 2019 (“Ans.”), and the Reply Brief filed April 23, 2019 (“Reply Br.”). Appeal 2019–003943 Application 14/676,289 3 REFERENCES The Examiner relies upon the prior art below in rejecting the claims on appeal: Mills et al. (“Mills”) Ngo et al. (“Ngo”) Kibalo Kishida et al. (“Kishida”) US 2006/0228252 A1 US 2010/0323440 A1 US 9,023,273 B2 WO 2008/111530 A1 Oct. 12, 2006 Dec. 23, 2010 May 5, 2015 Sept. 18, 2008 REJECTIONS The Examiner maintains (Ans. 3) the following rejections on appeal: A. Claims 59–70 and 72 on the ground of nonstatutory double patenting type obviousness as being unpatentable over claims 1–14 of Kibalo. Final Act. 4–5.3 B. Claims 59–65 and 74 under 35 U.S.C. § 103(a) as obvious over Ngo in view of Kishida. Id. at 5–9. C. Claims 66–70 under 35 U.S.C. § 103(a) as obvious over Ngo in view of Kishida and Mills. Id. at 9–11. D. Claim 72 under 35 U.S.C. § 103(a) as obvious over Ngo in view of Kishida and Sun. Id. at 11. 3 The rejection does not address claim 74. In the event of further prosecution, we leave application of nonstatutory double patenting to claim 74 for the Examiner to address in the first instance. Appeal 2019–003943 Application 14/676,289 4 OPINION We review the appealed rejections for error based upon the issues identified by Appellant and in light of the arguments and evidence produced thereon. Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential), cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (“[I]t has long been the Board’s practice to require an applicant to identify the alleged error in the examiner’s rejections.”). After considering the evidence presented in this Appeal and each of Appellant’s arguments, we are not persuaded that Appellant identifies reversible error. Thus, we affirm the Examiner’s rejections for the reasons expressed in the Final Office Action and the Answer. We add the following primarily for emphasis. Rejection A, non-statutory double patenting. Appellant does not address this rejection. We, therefore, summarily affirm the rejection. Rejections B, C, and D, obviousness. Appellant does not present substantively separate arguments for these rejections and does not argue any claim recitations other than those of independent claim 59. Appeal Br. 7–12. We therefore limit our discussion to claim 59. All other claims stand or fall with that claim. See 37 C.F.R. § 41.37(c)(1)(iv). The Examiner finds that Ngo teaches providing a tissue sample comprising mammalian skin, removing an epidermal layer from the skin, applying sustained pressure for time sufficient to sterilize the tissue, and maintaining the temperature below 30ºC during application of the elevated pressure. Final Act. 5–6 (citing Ngo). The Examiner finds that Ngo does not teach applying the elevated pressure by placing the tissue in liquid. Id. at 7. The Examiner finds, however, that Kishida teaches preparing a soft tissue sample for transplantation by applying sustained elevated pressure by Appeal 2019–003943 Application 14/676,289 5 placing the tissue in liquid. Id. (citing Kishida). The Examiner also finds that Kishida teaches that its method disrupts bacteria in the tissue while also advantageously preventing unwanted swelling of the tissue. Ans. 5–6 (citing Kishida). The Examiner determines that a person of skill in the art would have applied the teachings of Kishida (use of a liquid) to achieve the elevated pressure of Ngo teaches because Kishida’s method “is recognized in the art to be effective in reducing bioburden while avoiding damage to the tissue.” Final Act. 8. Appellant argues that a person of skill in the art would not have modified Ngo with Kishida because Ngo requires use of supercritical carbon dioxide during its application of pressure. Appeal Br. 7–11. The Examiner disagrees by finding that Ngo teaches two distinct methods. Ans. 4. The Examiner explains that the rejection is based only on Ngo’s second method—a method that does not require supercritical carbon dioxide. As summarized below, the preponderance of the evidence supports the Examiner’s position that Ngo teaches two methods and that the second method does not require supercritical carbon dioxide. Ngo’s title, “PROCESS FOR STERILIZING ACELLULAR SOFT TISSUE UNDER PRESSURE,” does not reference supercritical carbon dioxide. Ngo’s abstract likewise does not reference supercritical carbon dioxide. Ngo’s Figure 1 is a schematic flow chart of Ngo’s process (Ngo ¶ 23), and Figure 1 indicates that “SUPER CRITICAL CO2” and “ULTRA HIGH PRESSURE” are distinct alternative final steps of the Ngo process. Ngo’s Summary of the Invention also does not reference supercritical carbon dioxide. Id. ¶¶ 12–22. Appeal 2019–003943 Application 14/676,289 6 Ngo’s more detailed explanation of its two examples indicates the examples are distinct. Ngo example 1 is entitled “Sterilization of Dermis with Supercritical CO2 Under Pressure,” and example 1’s final step states “[t]he dermis is then treated with supercritical CO2 under pressure from about 1400 to 2000 psi.” Id. ¶¶ 33–42 (emphasis added). In contrast, Ngo example 2 is entitled “Sterilization of Dermis with Ultra High Pressure,” and example 2’s final step states “[t]he dermis is then sterilized under ultra high pressure.” Id. ¶¶ 43–53 (emphasis added). Ngo’s second example does not reference supercritical carbon dioxide. The different language of these two examples suggests that the “Ultra High Pressure” example (example 2) does not make use of supercritical carbon dioxide. Appellant emphasizes Ngo paragraph 32. Appeal Br. 10–11; see also Reply Br. 3. That paragraph states the “dermis is [then] sterilized with supercritical CO2 at a temperature ranging from 10 º C–80º C at a pressure ranging from 1200–2200 psi for a period ranging from about 10 to about 200 minutes or is alternatively sterilized under ultra high pressure ranging from 65,000–125,000 psi at a temperature ranging from -10º C–30º C for a period ranging from 1–30 minutes.” Ngo ¶ 32 (emphasis added). In view of the other context Ngo provides, as discussed above, this paragraph is best understood as stating that “supercritical carbon dioxide” and “ultra high pressure” are alternative and distinct sterilization methods. Id. Because Ngo teaches an “ultra high pressure” method (i.e., method 2) that does not involve supercritical CO2, a person of skill in the art would naturally look to other references to ascertain how to implement the ultra high pressure method. Id. The teachings of Kishida provide such an implementation with the advantage of, for example, preventing swelling of Appeal 2019–003943 Application 14/676,289 7 the tissue. Ans. 6. Appellant’s argument, therefore, does not identify error in the Examiner’s rejections, and we sustain the rejections. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 59–70, 72 Obviousness-type double patenting, Kibalo 59–70, 72 59–65, 74 103 Ngo, Kishida 59–65, 74 66–70 103 Ngo, Kishida, Mills 66–70 72 103 Ngo, Kishida, Sun 72 Overall Outcome 59–70, 72, 74 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation