Ex Parte Clairaz et al

Patent Trial and Appeal Board

Mar 27, 2018

12088506 (P.T.A.B. Mar. 27, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/088,506 03/28/2008 Philippe Clairaz
1444 7590 03/27/2018
Brawdy and Neimark, PLLC
1625 K Street, N.W.
Suite 1100
Washington, DC 20006
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.
CLAIRAZ=l 1849
EXAMINER
HURST, JONATHAN M
ART UNIT PAPER NUMBER
1799
MAILDATE DELIVERY MODE
03/27/2018 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 PHILIPPE CLAIRAZ,
ANNE-LINDA VAN KAPPEL,
and FRANCIS LESIEUR
Appeal 2016-006787
Application 12/088,506
Technology Center 1 700
Before CATHERINE Q. TIMM, DONNA M. PRAISS, and
N. WHITNEY WILSON, Administrative Patent Judges.
TIMM, Administrative Patent Judge.
DECISION ON APPEALl
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellants2 appeal from the
Examiner's decision to reject claims 1-10 and 12-19. We have jurisdiction
under 35 U.S.C. § 6(b).
We REVERSE.
1 In explaining our Decision, we cite to the Specification of March 28, 2008
(Spec.), Final Office Action of May 6, 2015 (Final), Appeal Brief of October 26,
2015 (Appeal Br.), Examiner's Answer of April 28, 2016 (Ans.), and Reply
Brief of June 28, 2016 (Reply Br.).
2 Appellants identify the real party in interest as Cryo Bio System. Appeal
Br. 4.
Appeal 2016-006787
Application 12/088,506
The claims are directed to a kit for packaging a biological substance to
be immersed in a liquid cryogenic agent such as liquid nitrogen. See, e.g.,
claim 1. The kit includes a sheathing and a support. These may be
packaged, for instance, in a peelable tray 5 as shown in Figure 1 along with a
plunger 4. Spec. 6:30-34. The support includes a zone (e.g., trough 13) for
receiving a predetermined volume, such as a drop, of a biological substance.
Spec. 5:30-35; Fig. 1. To package the biological sample, an operator opens
the package, deposits the sample onto trough 13 of support 3, introduces
support 3 into thin tube 6 of sheathing 2, uses the plunger to push support 3
a certain distance into sheathing 2, and welds end 8 of the sheath closed.
Spec. 7:2-28; Figs. 3-5. Importantly, Appellants' kit includes a ballast
weight in one end of the thin tube of the sheathing. On assembly, the
combination of the sealed thin tube of the sheath with the ballast weight, the
support, and the sample are such that the sheathing self-immerses in liquid
nitrogen and the ballast weight causes the sheathing to assume a vertical
orientation in the liquid nitrogen. Claim 1 is illustrative:
1. A kit for packaging a predetermined volume of a
biological substance, said kit comprising:
a sheathing configured to be immersed in a cryogenic
agent, including a thin tube having two opposed ends and an
inside diameter, and
a support including a zone for receiving said
predetermined volume, said support being configured to be
introduced into said thin tube and having a maximum
transverse dimension less than the inside diameter of said thin
tube,
wherein said sheathing further includes a ballast weight
associated with said thin tube only at only one end of said
sheathing,
further wherein said thin tube, said ballast weight and
said support are configured so that, after said kit is assembled
and after said thin tube is sealed at both ends, with said
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Appeal 2016-006787
Application 12/088,506
support introduced inside said thin tube and with said volume of
substance received in said support, said sheathing self-immerses
in liquid nitrogen without surface floating, including when
said predetermined volume is a drop,
further wherein said ballast weight has a weight that
causes said sheathing, when in the liquid nitrogen, to assume a
vertical orientation by the effect of said ballast weight, with
the one end of said sheathing vertically below the other end
thereof, thus preventing residual air contained in said sheathing
from causing said sheathing to float on the surface of the
liquid nitrogen, and
further wherein said ballast weight is fabricated to have a
given cross-sectional configuration.
Appeal Br. 21 (claims appendix) (emphasis added).
The Examiner maintains the following rejections: 3
A. The rejection of claims 1, 8, 9, 12, 16, and 18 under 35 U.S.C.
§ 103(a) as obvious over Kuwayama 4 in view of Kuleshova; 5
B. The rejection of claims 10, 13, 14, and 19 under 35 U.S.C.
§ 103(a) as obvious over Kuwayama in view of Kuleshova and
further in view of Cassou '562; 6
C. The rejection of claim 15 under 35 U.S.C. § 103(a) as obvious
over Kuwayama in view of Kuleshova and Cassou '562 and
further in view of Ambartsoumian; 7
3 The rejection of claims 1-10 and 12-19 under 35 U.S.C. § 112 was
withdrawn. Ans. 4.
4 Kuwayama et al. US 2004/0259072 Al, published December 23, 2004.
5 L.L. Kuleshova and J.M. Shaw, A strategy for rapid cooling of mouse
embryos within a double straw to eliminate the risk of contamination during
storage in liquid nitrogen, European Society of Human Reproduction and
Embryology, Vol. 15, No. 12, pp. 2604-2609, 2000.
6 Cassou et al. US 5,545,562, issued August 13, 1996.
7 Ambartsoumian US 2005/0247782 Al, published November 10, 2005.
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Appeal 2016-006787
Application 12/088,506
D. The rejection of claims 1-7 and 16 under 35 U.S.C. § 103(a) as
obvious over Cassou '305 8 in view of Kuleshova;
E. The rejection of claims 1-7 and 16 under 35 U.S.C. § 103(a) as
obvious over Cassou '305 in view of Nakagata, 9 Marshall, 10
Greenberg, 11 and Kuleshova; and
F. The rejection of claim 17 under 35 U.S.C. § 103(a) as obvious
over either: (1) Cassou '305 in view of Kuleshova or (2) Cassou
'305 in view of Nakagata, Marshall, Greenberg, and Kuleshova;
each in view of Isachenko.12
OPINION
According to Appellants, the error in all the rejections of claim 1 is the
same: None of the applied references discloses a device for packaging a
biological substance that includes a ballast weight located at one end of the
sheathing to cause the sheathing, when in liquid nitrogen (LN), to assume a
vertical orientation by the effect of the ballast weight. Appeal Br. 13.
Appellants have identified a reversible error in the Examiner's
rejections.
In order to consider Appellants' argument, we consider the meaning of
ballast weight. According to the Merriam-Webster online dictionary, a
ballast is "a heavy substance (such as rocks or water) placed in such a way as
to improve stability and control (as of the draft of a ship or the buoyancy of
a balloon or submarine)." Merriam-Webster.com/dictionary/ballast (last
8 Cassou EP 0 635 305 Al, published January 25, 1995.
9 N. Nakagata, Cryopreservation of mouse spermatozoa, Mammalian Genome
11, 572-576, 2000.
10 Marshall US 4, 761,314, issued August 2, 1988.
11 Greenberg et al. US 6,332,822 B2, issued December 25, 2001.
12 V. Isachenko et al., Aseptic technology of vitrification of human pronuclear
oocytes using open-pulled straws, Human Reproduction Vo. 20, No. 2, pp.
492-496. 2005.
4
Appeal 2016-006787
Application 12/088,506
accessed March 22, 2018). The Specification describes a ballast weight that
is a slug, ball, or ring made of material of greater density than that of the
cryogenic liquid agent, such as metal. Spec. 2:2-5, 2:16-17, 10:3-9, 11:25-27,
12:2-3; Figs. 10 (at 24), 14 (at 28), 15 (at 29). According to the Specification,
"[t]he integration of a ballast weight into the sheathing enables the sheathing
to be immersed efficiently in the liquid nitrogen and prevents residual air
contained in the sheathing from causing it to float." Spec. 1: 27-30. This
purpose is consistent with the ordinary and customary meaning of "ballast"
as defined by Merriam-Webster. So, to be a ballast weight, the structure
must be a heavy substance placed in a location that improves stability and
control. In the kit of claim 1, the ballast weight is placed at one end of the
thin tube of the sheath.
Next we consider the Examiner's interpretation of the clause requiring
the ballast weight have
a weight that causes said sheathing, when in the liquid
nitrogen, to assume a vertical orientation by the effect of said
ballast weight, with the one end of said sheathing vertically
below the other end thereof, thus preventing residual air
contained in said sheathing from causing said sheathing to float
on the surface of the liquid nitrogen.
Claim 1. According to the Examiner, the weight limitation is directed to an
intended use that the prior art is capable of achieving. See, e.g., Final 6-7;
Ans. 11. Contrary to the Examiner's determination, the clause is not merely
functional; it limits the weight of the ballast weight to one that causes the
vertical orientation result recited. This limitation must also be read in
combination with the other limitations on the structure of the sheath and
support. Together, when assembled, the sheath, the ballast within the thin
tube of the sheath, and the support together with the biological sample must
have a structure that will achieve the self-immersing result recited in claim
1. The recited limitations on the assembly limit the structure of the sheath
and support of the kit.
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Appeal 2016-006787
Application 12/088,506
In Rejections A-C, the Examiner finds Kuwayama's cylindrical
protection member 3 is a ballast weight associated at one end a thin tube of a
sheathing. Final 4. But Kuwayama's cylindrical protection member 3 is
mounted onto the small-diameter part 22 of tube 2. Kuwayama if 46; Fig. 1,
8. Tube 2 collects the biological sample (egg); it is not a sheath into which the
sample collecting tube will be introduced. The cylindrical protection member
acts more like the sheath than a ballast weight; it is inserted over, and serves
to protect, small diameter part 22 of tube 2 so the small-diameter part does
not contact the bottom surface of the liquid nitrogen-filled container when
introduced into the container. Id. Although there may be some basis to infer
that Kuwayama would have suggested to the ordinary artisan that the
cylindrical protection member might cause the tube/protection-member
assembly to sink to the bottom of the nitrogen-filled container, there is
insufficient basis to support a finding that an assembly including both a
sheathing and support, which the Examiner relies on Kuleshova as teaching,
would have the structure required to sink vertically as required by claim 1.
Again, claim 1 requires the ballast weight be located at one end of a thin tube
of the sheathing that will, in the assembly, receive the support.
In Rejection D, the Examiner finds Cassou '305's identification marker
6 is a ballast weight on thin tube sheathing 3. Final 13. Cassou '305 teaches
a plastic ring 5 having identifying information 6 placed into flexible plastic
tube 3 that stores a liquid sample. Cassou '305 p. 1-2. Cassou discloses
nothing about the weight of ring 5 or mark 6. Nor does Cassou '305 state
anything about the orientation of the tube in a liquid medium, much less the
ability of the assembly to self-immerse when the assembly contains a support
carrying a biological sample. According to the Examiner, weight 6 is made of
various materials having a density/specific gravity greater than liquid
nitrogen that are capable of causing vertical sinking depending on the
amount and type of air, buffers, cryoprotectants, and samples used. Final
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Appeal 2016-006787
Application 12/088,506
13-14. But the claim requires more than just a hunk of material at one end;
it requires the ballast weight be present at one end of a sheathing that, when
assembled with a support carrying a biological sample and sealed, will self-
immerse and that the weight of the ballast weight be such that the sheathing
will assume a vertical orientation. These limitations require a combination of
structures, each with structures, locations, and orientations to accomplish the
function. The teachings of Cassou '305 are not sufficiently specific to
establish that the functional capability is present in a kit suggested by
Cassou '305 in view of Kuleshova.
In Rejection E, the Examiner again relies on Cassou '305 and for the
reasons we stated above, we determine the finding is lacking. Alternatively,
the Examiner relies on the combination of Nakagata, Marshall, and
Greenberg as suggesting the use of a ballast weight in the plastic tube of
Cassou '305 and further using Cassou '305's plastic tube in the outer
sheathing as taught Kuleshova.
Nakagata teaches freezing mouse spermatozoa in a straw. Nakagata
p. 57 4-75 (procedure if 4). The straw is a sample container, i.e., a support in
the words of claim 1. Nakagata includes 100 µl of HTF medium in the
sample container (straw) so it sinks, i.e., the medium acts as a weight. Id.
Importantly, the medium is shown as injected into the central portion of the
straw (Fig. 4). The straw is placed loosely within a freezing canister to float
on liquid nitrogen (Fig. 5-1) before sinking the freezing canister into the
liquid nitrogen (Fig. 5-2). Nakagata p. 575 (procedure iii! 6-7). Also
importantly, when thawing, the straw is shown as leaning in a container of
water instead of aligning vertically. Fig. 6. Nakagata specifically discloses a
weight yet does not suggest that the weight is at the end of a thin tube of a
sheathing or has the necessary weight to achieve the required vertical
orientation. Although Marshall teaches a weight that compensates for
buoyancy and causes an article to sink and Greenberg teaches placing a
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Appeal 2016-006787
Application 12/088,506
ballast weight at one end of a cylindrical article to achieve a vertical
orientation, the claims require a kit with a ballast weight at one end of a thin
tube of a sheathing. There is no suggestion of a sheathing with a ballast
weight in a kit with a support that collects a biological sample that meets the
other structural limitations that arise when one assembles the kit.
CONCLUSION
In summary:
1, 8, 9, 12, § 103(a) Kuwayama, 1, 8, 9, 12,
16, 18 Kuleshova 16, 18
10, 13, 14, § 103(a) Kuwayama, 10, 13, 14,
19 Kuleshova, 19
Cassou '562
15 § 103(a) Kuwayama, 15
Kuleshova,
Cassou '562,
Ambartsoumian
1-7, 16 § 103(a) Cassou '305, 1-7, 16
Kuleshova
1-7, 16 § 103(a) Cassou '305, 1-7, 16
Nakagata,
Marshall,
Greenberg,
Kuleshova
17 § 103(a) (Cassou '305, 17
Kuleshova) or
(Cassou '305,
Nakagata,
Marshall,
Greenberg,
Kuleshova),
Isachenko
Summary 1-19
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Appeal 2016-006787
Application 12/088,506
DECISION
The Examiner's decision is reversed.
REVERSED
9