Ex Parte Cecchi

Patent Trial and Appeal Board

Jun 9, 2015

12454400 (P.T.A.B. Jun. 9, 2015)

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).
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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).
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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.)
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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
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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
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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
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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
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