Ex Parte CecchiDownload PDFPatent Trial and Appeal BoardJun 9, 201512454400 (P.T.A.B. Jun. 9, 2015) 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. 12/454,400 05/19/2009 Michael D. Cecchi H-1406 9468 7590 06/09/2015 William W. Jones 6 Juniper Lane Madison, CT 06443 EXAMINER TON, THAIAN N ART UNIT PAPER NUMBER 1632 MAIL DATE DELIVERY MODE 06/09/2015 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 MICHAEL D. CECCHI ____________ Appeal 2012-008991 Application 12/454,400 Technology Center 1600 ____________ Before DONALD E. ADAMS, DEMETRA J. MILLS, and ROBERT A. POLLOCK, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL1 This appeal under 35 U.S.C. § 134(a) involves claims 7–21 (Ans. 3). Examiner entered rejections under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 Appellant identifies the Real Party in Interest as “Genx International Inc.” (see App. Br. 1). Appeal 2012-008991 Application 12/454,400 2 STATEMENT OF THE CASE Appellant’s “invention relates to a[] . . . method for the preparation of mammalian cells and tissue specimens for culturing, growing, transferring, cryo-preserving, freezing and vitrifying and the thawing and warming of such specimens, and the use of sequential media products” (Spec. 1) Claims 7, 19, and 20 are representative and reproduced in the Claims Appendix of Appellant’s Brief. Claims 7–13 and 16–18 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Abe2 and Voelkel.3 Claims 7, 14, 15, 19, and 21 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Cho4 and Voelkel. Claim 20 stands rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Cho, Voelkel, and Abe. ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? 2 Yasuyuki Abe et al., Feasibility of a Nylon-Mesh Holder for Vitrification of Bovine Germinal Vesicle Oocytes in Subsequent Production of Viable Blastocysts, 72 BIOLOGY OF REPRODUCTION 1416–1420 (2005). 3 Voelkel, US 5,160,312, issued Nov. 3, 1992. 4 Hyon-Jin Cho et al., An improved protocol for dilution of cryoprotectants from vitrified human blastocysts, 17(9) HUMAN REPRODUCTION 2419–2422 (2002). Appeal 2012-008991 Application 12/454,400 3 FACTUAL FINDINGS (FF) FF 1. Examiner relies on Abe to suggest the “stepwise preparation of bovine cumulus-oocyte complexes (GV-COCs)” by exposing the GV-COCs “stepwise to solution A, solution B, [and] [s]olution C” to “minimize toxicity to the cells” (Ans. 4; see generally Abe 1416: Abstact; id. at 1418: Discussion). FF 2. Abe suggests that “GV-COCs were vitrified using a nylon-mesh holder” to expose the GV-COCs in a stepwise fashion to three different solutions (solution A, solution B, and solution C) “in 35-mm culture dishes” prior to cyrostorage. After cryostorage the GV-COCs were ultrarapidly thawed, and the cryoprotectants were removed in a stepwise manner at 37°C . . . [comprising the transfer of the nylon-mesh holder into] a sequential series of 0.5, 0.25, and 0.125 M sucrose or trehalose . . . and finally . . . into PBl[5] . . . in . . . culture dishes. (Abe 1417: Vitrification and Thawing; Ans. 4). FF 3. Examiner relies on Cho to suggest “the thawing of blastocysts in a 6- step cryoprotectant dilution method, wherein the blastocysts were sequentially transferred into drops containing 10% hFF in DPBS supplemented with 0.4, 0.3, 0.2, and 0 mol/l sucrose . . . [and] then washed three times in culture medium” (Ans. 5; see Cho 2420: Thawing of Blastocysts derived from 2PN zygotes (clinical use)). FF 4. Examiner finds that neither Abe nor Cho “specifically teach that the stepwise process is performed using the steps recited in [Appellant’s] 5 “The most common salt solution used for freezing embryos” (Voelkel, col. 4, l. 67 – col. 5, l. 4). Appeal 2012-008991 Application 12/454,400 4 claim[s]” and relies on Voelkel to make up for this deficiency in Abe and Cho (Ans. 4). FF 5. Voelkel suggests “a process for cryopreservation of embryos” (Voelkel, col. 1, ll. 12–13). FF 6. Voelkel suggests “a cryoprotective container to store frozen embryos, wherein cryoprotectant can be mixed with culture media or other solution (col. 4-5, bridging ¶)” (Ans. 4). FF 7. Voelkel suggests that “[t]he placement of the embryo in the cryoprotective solution takes place in a petri dish with subsequent equilibration preferably taking place in a container suitable for cryopreservation that allows for direct transfer to recipient animals” (Voelkel, col. 5, l. 67 – col. 6, l. 3). FF 8. Voelkel’s preferred embodiment is a cryoprotective container in a tubular shape and made of a biocompatible plastic that can be inserted into a standard artificial insemination gun or an artificial insemination gun modified for embryo transfer. . . . This allows the embryo to remain in the container throughout the freezing, thawing, and transfer procedures thereby eliminating handling of the embryo. (Id. at col. 6, ll. 3–11.) Appeal 2012-008991 Application 12/454,400 5 FF 9. Voelkel’s Figure 1 is reproduced below: “FIG. 1 depicts . . . [Voelkel’s] tubular container 1 after the embryo 10 has been placed inside and sealed” (Id. at col. 6, ll. 24–25). FF 10. Voelkel suggests that [t]he tubular container 1 is closed at one end 2 . . . [and] has an open end opposite to end 2 for receiving the appropriate volumes of liquid and embryo. The first column of liquid 6 above the plug material 5 contains . . . the cryoprotective solution. Above the first column of liquid is a second column of liquid 9 which is separated from the first by an air bubble 8. The second column of liquid 9 is a cryoprotective solution which contains the embryo 10. An air bubble 12 separates the second column of liquid 9 from a third column of liquid 13. . . . The upper end of the tubular container is heat sealed by melting the end of the plastic straw to form a seal 15. The solutions in the third column 13 and first column 6 of the container help to Appeal 2012-008991 Application 12/454,400 6 assure that the embryo is expelled from the gun when transferred to the recipient. (Id. at col. 6, ll. 25–53.) FF 11. Voelkel suggests that “[w]hen the time comes to remove the embryos from storage in liquid nitrogen for transfer to recipient animals, the . . . cyroprotective containers are placed into a water bath . . . [and] the thawed embryo is then directly transferred to the recipient animal.” (Id. at col. 8, ll. 11–33; see id. col. 1, ll. 60–64 (“developing a process by which the frozen embryo can be thawed within the straw and transferred directly to a recipient female without seriously diminishing pregnancy rates would be very important commercially”).) FF 12. Examiner finds that the combination of Cho and Voelkel fails to suggest “a step of covering the liquids in the receptacle with a layer of oil so as to prevent evaporation of said liquids from the receptacle” and relies on Abe to make up for this deficiency in the combination of Cho and Voelkel (Ans. 6). ANALYSIS The rejections over Abe or Cho in combination with Voelkel: Based on the combination of Abe and Voelkel, Examiner concludes that, at the time Appellant’s invention was made, it would have been prima facie obvious “to modify the teachings of Abe, to include a single container [, as suggested by Voelkel,] and then subsequently do stepwise exposure [of a biological specimen] to the cryoprotectant, as taught by Abe” (Ans. 4). Similarly, with respect to the combination of Cho and Voelkel, Examiner concludes that, at the time Appellant’s invention was made, it would have been prima facie obvious “to modify the teachings of Cho, to include a Appeal 2012-008991 Application 12/454,400 7 single container[, as suggested by Voelkel,] and then subsequently dilute the cryoprotectant, as shown by Cho, in a six-step dilution method” (Ans. 6). We are not persuaded. Appellant’s claimed invention requires, inter alia, the step of placing a biological specimen into a receptacle containing a first liquid and then subsequently adding additional liquids to the receptacle to dilute, in a stepwise fashion, the liquid and/or mixture in the receptacle (see e.g., Appellant’s independent claims 7, 16, and 19). Examiner relies on Voelkel to suggest a cryoprotection container in which an embryo that was previously exposed to a cryoprotective solution in a petri dish is stored prior to thawing and immediate transfer to a recipient animal (FF 5–11). Notwithstanding Examiner’s assertion to the contrary, Voelkel suggests the careful placement of liquids and embryo in the cryoprotection container so that upon thawing the arrangement of agents in the container facilitate the embryo’s discharge from the container using an artificial insemination gun (see FF 10). As far as exposing the biological sample to a cryoprotective solution, Voelkel suggests this is initially done in a petri dish, “with subsequent equilibration preferably taking place in a container suitable for cryopreservation that allows for direct transfer to recipient animals” (FF 7). Therefore, at best, the combination of Abe or Cho with Voelkel would have suggested a stepwise process for treating the biological specimen prior to and after placing an embryo in Voelkel’s storage container, which is counter to Voelkel’s careful arrangement of reagents in the storage container to facilitate the embryo’s discharge from the container using an artificial Appeal 2012-008991 Application 12/454,400 8 insemination gun (see FF 1–4; cf. FF 10; see generally App. Br. 7–8; Reply Br. 2). The combination of Cho, Voelkel, and Abe: Based on the combination of Cho, Voelkel, and Abe, Examiner concludes that, at the time Appellant’s invention was made, it would have been prima facie obvious to “layer mineral oil over the liquid in order to prevent evaporation” (Ans. 6). Examiner, however, failed to establish that Abe makes up for the deficiency in the combination of Cho and Voelkel discussed above. CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness. The rejection of claims 7–13 and 16–18 under 35 U.S.C. § 103(a) as unpatentable over the combination of Abe and Voelkel is reversed. The rejection of claims 7, 14, 15, 19, and 21 under 35 U.S.C. § 103(a) as unpatentable over the combination of Cho and Voelkel is reversed. The rejection of claim 20 under 35 U.S.C. § 103(a) as unpatentable over the combination of Cho, Voelkel, and Abe is reversed. REVERSED lp Copy with citationCopy as parenthetical citation