Ex Parte Thorne et al

Patent Trial and Appeal Board

Oct 26, 2018

12443199 (P.T.A.B. Oct. 26, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/443, 199 05/05/2010 Robert E. Thorne
44564 7590 10/30/2018
Bond, Shoeneck & King, PLLC
One Lincoln Center
Syracuse, NY 13202
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.
606Pl87-03 7105
EXAMINER
TRPISOVSKY, JOSEPH F
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
10/30/2018 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):
bskpto@bsk.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT E. THORNE, SCOTT MCFARLANE, and
MATTHEW WARKENTIN
Appeal2018-000342
Application 12/443, 199
Technology Center 3700
Before: JENNIFERD. BAHR, WILLIAM A. CAPP, and
LEE L. STEPINA, Administrative Patent Judges.
STEPINA, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants 1 appeal under 35 U.S.C. § 134 from the Examiner's
decision rejecting claims 1, 4, 5, 14, 17-26, and 28-30. 2 We have
jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 Appellants' Brief indicates that Cornell University is the real party in
interest. Br. 3.
2 Claims 2, 3, 6-13, 15, and 16 are withdrawn. Appeal Br. 16-18 (Claims
App.).
Appeal2018-000342
Application 12/443, 199
CLAIMED SUBJECT MATTER
The claims are directed to a system for increased cooling and thawing
rates of protein solutions and cells, for optimized cryopreservation and
recovery. Claim 1, reproduced below, is illustrative of the claimed subject
matter:
1. A system for precision freezing of liquids contammg
biological components that are sensitive to cooling rate, changes
in solute and solvent concentrations, and to degradation of the
biological components by oxygen, comprising:
a dispenser for converting a liquid sample into a plurality
of uniform separated drops having a volume between 0.01 µland
10 µl and a surface area-to-volume ratio of 1000 m-1 or larger,
said dispenser including a dispensing tip to direct said drops into
or onto a cryogenic medium, wherein the system is characterized
by the active removal of a cold gas layer having a thickness
defined as the height above the cryogenic medium at which an
ambient temperature rises to at least one of: a water glass
transition temperature (Ta = about 150 K) and a water
homogeneous ice nucleation temperature (Th= about 231 K),
immediately adjacently above the cryogenic medium, by a forced
volume of warm, dry air actively disposed in the cold gas layer
prior to cooling of the liquid sample; and the presence of a warm
gas layer, where warm means at least one of: greater than the
sample's glass transition temperature, a water homogeneous ice
nucleation temperature, and a water melting point.
Appeal Br. 16 (Claims App.).
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Rinfret
Livesey
Craig
Berghoff
Huang
us 3,344,617
us 5,364,756
US 6,381,967 Bl
US 6,640,576 B2
US 2007/0037271 Al
2
Oct. 3, 1967
Nov. 15, 1994
May 7, 2002
Nov. 4, 2003
Feb. 15,2007
Appeal2018-000342
Application 12/443, 199
REJECTIONS
(I) Claims 1, 4, 5, 14, and 30 are rejected under 35 U.S.C. § 103(a)
as unpatentable over Craig, Huang, and Livesey.
(II) Claims 17-20, 22-26, 28, and 29 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Craig, Huang, Livesey, and Rinfret.
(III) Claim 21 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Craig, Huang, Livesey, Rinfret, and Berghoff.
OPINION
Re} ection (I)
Appellants make arguments for claims 1, 4, 5, 14, and 30 as a group.
See Br. 7, 13. We select claim 1 as representative. See 37 C.F.R. §
4I.37(c)(l)(iv).
The Examiner finds that Craig discloses most of the elements of the
system recited in claim 1, but does not disclose, along with associated
limitations, the (i) particular volume and surface area of the drops (droplets)
created by the dispenser or (ii) that the system provides the active removal of
a cold gas layer. Final Act. 4, 5. The Examiner relies on the teachings of
Huang to remedy the first of these deficiencies and relies on the teaching of
Livesey to remedy the second. See id. 4---6 (citing Huang ,r,r 4, 40-43;
Livesey, col. 1, 11. 15, col. 2, 11. 55---68, col. 6, 11. 45-50, 54---66, col. 7, 11. 15-
17, Fig. 3).
Referring to the Examiner's finding that Huang discloses droplet sizes
of 1 to 2 µl ( sizes within the range recited in claim 1 ), Appellants contend
that Huang fails to disclose controlling of the atmosphere and temperature
between Huang's dispensing tip and liquid nitrogen into which the droplets
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Application 12/443, 199
fall. Br. 11. According to Appellants, "[i]f one doesn't remove the cold gas
layer as taught by applicant, the optimum volume is larger than this [ ( 1 to 2
µl)] because using smaller volume drops does not increase the cooling rate."
Br. 11.
Appellants' argument on this point is unavailing because, as the
Examiner correctly finds (see Final Act. 4), Huang explicitly discloses
droplet sizes within the recited range. See Huang ,r,r 4, 24. Specifically,
Huang states, "[t]he volume of each microdrop is in the range of 1 to 15 µl,
preferably in the range of 5 to 9 µl, more preferably in the range of 3 to 4 µl
and most preferably in the range of 1 to 2 µl." Id. ,r 24. Accordingly,
contrary to Appellants' argument regarding an optimum volume larger than
1 to 2 µl, Huang discloses droplet sizes within the recited range and that
these sizes are preferred, regardless of whether Huang further discloses
controlling of the atmosphere downstream of Huang's dispensing tip. To the
extent Appellants intend to fault the disclosure of Huang as lacking active
removal of a cold gas layer, this argument amounts to an attack on the
references individually rather than on the combination of their teachings as
proposed by the Examiner. Specifically, Rejection (I) relies on Livesey, not
Huang, to teach temperature control of the area above a cooling medium.
See Final Act. 5.
Appellants next contend that the Examiner erred in determining that it
would have been obvious to implement the dispenser disclosed by Huang in
the system taught by Craig because doing so "would make the
cooling/vitrification performance of the Craig device worse, not better,
because the drops would be larger and therefore cool more slowly." Br. 11.
We disagree with Appellants because, as pointed out by the Examiner
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Application 12/443, 199
(Ans. 11-12), Huang teaches that volumes of 1 to 2 µl have been thought to
be optimal for improving the cooling rate during vitrification. Huang ,r 4.
Moreover, Appellants provide no objective evidence or persuasive technical
argument supporting the contention that implementation of a dispenser that
dispenses droplets within the 1 to 2 µl size range would be detrimental to the
functioning of Craig's system.
Appellants next contend that it makes no sense to rely on Livesey to
teach active removal of a cold gas layer, as claimed, because (i) Huang, like
Livesey, teaches the use of a nebulizer, and (ii) the flow of warm air taught
by Livesey does not qualify as active removal of a cold gas layer. Br. 13.
With respect to this second issue, Appellants contend that the flow of air in
Livesey "would be ineffective in removing the cold gas layer unless the flow
rate were so large as to blow the drops around, since this flow continues
during nebulized drop dispensing." Br. 13.
Appellants do not explain why the fact that Huang teaches the use of a
nebulizer would preclude the Examiner's citation to Livesey for what it
discloses, even if Livesey also teaches the use of a nebulizer. In other
words, we are not apprised of any reason the fact that Huang and Livesey
may use similar structure would mean that each of these references cannot
be relied upon for what it teaches.
As for the direction of flow and the effect of the warm air taught by
Livesey, column 6, lines 56-61 of this reference states:
Nebulizer 12 is mounted in such a manner that gas 28 can flow
past nebulizer 12 with laminar flow as indicated by arrows 32.
The flow of inert gas 28 ensures that the nebulized sample does
not undergo a slow precooling process prior to rapid cooling on
cryogenic surface 16.
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Application 12/443, 199
Thus, Livesey explicitly states that the flow of warm air prevents the
precooling process. In other words, Appellants' contention that this flow
would be ineffective is contrary to the teachings of Livesey.
We have considered all of Appellants' arguments in support of the
patentability of claim 1, but find them unavailing. Accordingly, we sustain
the rejection of claim 1 and claims 4, 5, 14, and 30 depending therefrom.
Re} ection (II)
In relation to Rejection (II), Appellants discuss only claim 17. See
Br. 13-14. Claim 17 depends from claim 1 and adds the requirement that
the system of claim 1 comprise "a container for storing frozen drops at
cryogenic temperature and a system for recovering said frozen drops by
rapid thawing." Appeal Br. 18 (Claims App.). The Examiner finds Rinfret
teaches a container Q and a warming system that meet these requirements.
Final Act. 7. The Examiner reasons that it would have been obvious to add
this container and warming system to the system disclosed by Craig "in
order to enhance the preservation of the drops for use by an end user." Id.
Appellants argue that Rinfret thaws drops in a steam column, uses an
air blower to keep the drops from overheating, and fails to disclose an
arrangement "that produces an abrupt transition from cryogenic temperature
gas to a warm liquid for thawing." Br. 14. Appellants provide no
explanation as to the relevance of these assertions to the rejection of claim
17, in particular, to the reliance on Rinfret to teach (i) a cooled container Q
for storing frozen drops at cryogenic temperature and (ii) a system for
recovering said frozen drops by rapid thawing. Rinfret discloses, in Figure 8
and column 11, lines 31-51, a cooled droplet container Q and a thawing
system that takes steps to prevent premature warming of the frozen droplets
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Application 12/443, 199
before thawing them. Thus, the Examiner's findings as to what Rinfret
discloses are supported by a preponderance of the evidence. Appellants do
not attack the Examiner's rationale for combining the teachings of Rinfret
with the system disclosed by Craig. See Br. 14. Accordingly, Appellants
have not apprised us of Examiner error in Rejection (II), and we therefore
sustain the rejection of claims 17-20, 22-26, 28, and 29 as unpatentable over
Craig, Huang, Livesey, and Rinfret.
Rejection (III)
Appellants make no additional arguments for the patentability of
dependent claim 21, and we therefore sustain the rejection of this claim for
the same reasons discussed regarding Rejections (I) and (II).
DECISION
The Examiner's decision to reject claims 1, 4, 5, 14, 17-26, and 28-
3 0 is affirmed.
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)(l )(iv).
AFFIRMED
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