Ex Parte Fissore et al

Patent Trial and Appeal Board

Aug 31, 2017

12502863 (P.T.A.B. Aug. 31, 2017)

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.
12/502,863 07/14/2009 Davide Fissore SS629.1001 7011
122515 7590 09/05/2017
Silvia Salvadori, P.C.
Silvia Salvadori
270 Madison Avenue, 8th Floor
New York, NY 10016
EXAMINER
YUEN, JESSICA JIPING
ART UNIT PAPER NUMBER
3743
NOTIFICATION DATE DELIVERY MODE
09/05/2017 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):
silvia@salvadorilaw.com
silvia30121 @ me. com
eofficeaction @ appcoll.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVIDE FISSORE, ANTONELLO BARRESI, and
ROBERTO PISANO
Appeal 2016-001812
Application 12/502,8631
Technology Center 3700
Before JOHN C. KERINS, BRANDON J. WARNER, and
FREDERICK C. LANEY, Administrative Patent Judges.
LANEY, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Davide Fissore et al. (Appellants) appeal under 35 U.S.C. § 134(a)
from the Examiner’s non-final decision (mailed January 2, 2015, hereinafter
“Non-Final Act.”) rejecting claims 18—27 and 29—35.2 We have jurisdiction
over this appeal under 35 U.S.C. § 6(b).
We REVERSE.
1 According to Appellants, the real party in interest is Azbil Telstar
Technologies, SL. Br. 3 (filed Mar. 23, 2015).
2 Claims 1—17, 28, and 36 have been canceled. Non-Final Act. 2.
Appeal 2016-001812
Application 12/502,863
INVENTION
Appellants’ invention relates to “methods for monitoring a freeze-
drying process in a freeze-dryer; in particular it refers to a method for
monitoring secondary drying of a freeze-drying process, for example, of
pharmaceutical products arranged in containers.” Spec. 1.
Claims 18 and 29 are independent claims. Claim 18 is illustrative of
the claimed invention and reads as follows:
18. Method for calculating a residual moisture concentration
and/or desorption rate of a product during a secondary drying
phase of a freeze-drying process in a freeze-dryer apparatus
including a drying chamber and a condenser chamber where
vapour generated by drying process flows, said apparatus being
provided with a pressure sensor that can be isolated for
performing pressure rise tests and measuring a total pressure
inside said drying chamber, said method comprising the steps of:
a) setting a desired final residue moisture concentration
and/or a desired final desorption rate of said product;
b) measuring initial residual moisture concentration and/or
desorption rate and estimating kinetic constants of a kinetic
model of the drying process, said kinetic model being suitable
for calculating the residual moisture concentration and/or
desorption rate of said product;
c) closing a valve placed on a duct connecting said drying
chamber to said condenser chamber for a preselected period of
time;
d) measuring a pressure change in said drying chamber;
e) calculating a desorption rate from the closing time
period of step c) and the pressure change of step d);
f) repeating steps c)-e) to calculate residual moisture
concentrations and/or desorption rates at pre-specified time
intervals;
g) integrating the calculated residual moisture
concentrations and/or desorption rate from said initial conditions
to the calculated residual moisture concentrations and/or
desorption rates of the pre-specified time intervals of step e) to
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Application 12/502,863
nn _
u rv exp
determine a current residual moisture concentration of the drying
product;
wherein if said current residual moisture concentration
and/or said current final desorption rate is lower than or equal to
said desired residual moisture concentration and/or to said
desired desorption rate then said secondary drying phase ends,
and wherein a first pressure rise test at time t=to at the beginning
of the secondary drying phase is performed and a first value of
experimental desorption rate (DRexA o) of said product is
calculated using the equation:
— -------- (eq. 4)
\dt/ t=to mdried
where:
DRexp. experimental desorption rate, [% water and/or
solvent s'1]
P: measured pressure, [Pa]
t: time, [s]
to'. time instant at the beginning of the pressure rise test, [s]
R: gas constant [8,314 J mol'1 K'1]
T: temperature of the vapour, [K]
V: (free) volume of drying chamber, [m3]
Mw: molecular weight of water and/or solvent, [kg mol'1]
mdried'. mass of the dried product, [kg]
a second pressure rise test at a successive time t=tj is
performed and a second value of experimental desorption rate
{DRexp, i) of said product is calculated using the equation:
a third pressure rise test at time t=t2 is performed and
calculating a third value of experimental desorption rate (DRexp, i)
of said product (step 3) is calculated using the equation eq.4
Ut=t— ^-4>DRexp
VMU
RT mdried
and wherein said initial conditions (Cs,o) and kinetic
constants (ko, ki, ki) of a kinetic model of the drying process, said
kinetic model being suitable for calculating a residual moisture
content (C,) and/or desorption rate (DRtheor) of said product are
calculated using the equations:
DRexp,o DRtheor,o koCs,o (eq. 13)
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Application 12/502,863
DKexp.n = DRtheor0 = -k,Cs„e 't‘"‘ (eq. 14)
DRexp,0 = DRtheor,o = (eq. 15)
where:
DR exp, j '■ experimental desorption rate at time tj, [% water
and/or solvent s-1]
DRtheor,j'- desorption rate (theoretical value) at time tj [%
water and/or solvent s-1]
Cs 0: value of the residual moisture [% water and/or solvent
over dried product] at the beginning of the secondary drying
phase (t = t0);
kj\ kinetic constant of the process at time t = tj (with j =
0, 1,2ms-1].
and a minimisation algorithm to solve the minimum least
square problem described by equation:
2
Xi=o{DRexp,i — DRtheor,i) 16)cs,0,ki
calculating at time t = t2 a respective residual moisture
content (cs 2) and a respective desorption rate (DRtheor 2 ) (step
5) respectively using the equations:
Cs = Cs 0 nU e~ki<-ti~tl-1>e~ki^t~tl-^ (eq. 11)
DRtheor = ~kjCs,o nCl (eq. 12)
Br. 23—26 (Claims App.).
REJECTIONS
I. The Examiner rejected claims 18—27 and 29—35 under
35 U.S.C. § 112, first paragraph, as failing to comply with the
written description requirement.
II. The Examiner rejected claims 18—27 and 29—35 under
35 U.S.C. § 112, first paragraph, as failing to comply with the
enablement requirement.
III. The Examiner rejected claims 18—27 and 29—35 under
35 U.S.C. § 112, second paragraph, as indefinite for failing to
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Application 12/502,863
particularly point out and distinctly claim the subject matter
which Appellants regard as the invention.
ANALYSIS
Rejection I (written description)
The Examiner finds the claim limitation “a freeze dryer apparatus
including a secondary drying chamber and a condenser chamber where
vapors generated by drying process flows, said apparatus being provided
with a presser sensor that can be isolated for performing pressure rise tests
and measuring a total pressure inside said drying chamber” lacks support
because it is only supported by the “newly added Fig[ure] 1.” Non-Final
Act. 3^4. In the Answer, the Examiner clarifies this limitation lacks support
in the original Specification regarding “the exact locations of the claimed
components as shown in new Fig[ure] 1.” Ans. 7. The Examiner requests
“the Board ... to adjudicate both [the] new matter rejection of claims under
35 USC 112 and the objection to the [Specification for new matter added in
new Fig[ure] 1 . . . under 35 U.S.C. 132(a) because the new matter issues are
the same.” Id.
In other words, the Examiner finds, while newly added Figure 1
would support the above claim limitation, it is the only support and,
presuming it is properly objected to as new matter, Appellants’ original
Specification fails the written description requirement for the limitation.
Therefore, the Examiner’s objection to “newly added” Figure 1 and written
description rejection of the claims both rest on whether Appellants’
Specification, as originally filed, discloses what is shown in Figure 1,
reproduced below.
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Pressure (vacuum)
transducer Condenser
0 Chamber
As shown above, Figure 1 is a schematic of a freeze-dryer apparatus for
performing a freeze-drying process. See Amended Specification (received
Nov. 11, 2014). For the following reasons, Appellants’ contentions are
persuasive that both the Examiner’s objection to Figure 1 and written
description rejection of the claims are improper.
Appellants refer to page 2 of the original Specification as support for
Figure 1 and as evidence Appellants conveyed the subject matter shown
therein with reasonable clarity to demonstrate they were, as of the effective
filing date, in possession of the depicted (and claimed) subject matter. Br.
6—7. The original Specification describes, at page 2,
A known freeze-dryer apparatus for performing a freeze-
drying process usually comprises a drying chamber and a
condenser chamber interconnected by a duct that is provided
with a valve that allows isolating the drying chamber when
required during the process.
The drying chamber comprises a plurality of temperature-
controlled shelves arranged for receiving containers of product
to be dried. The condenser chamber includes condenser plates
or coils having surfaces maintained at very low temperature. . . .
The condenser chamber is also connected to one or more vacuum
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Application 12/502,863
pumps so as to achieve high vacuum values inside both
chambers.
Freeze-drying process typically comprises three phases: a
freezing phase, a primary drying phase and a secondary drying
phase.
In response to the above disclosure, the Examiner appears to criticize
its adequacy as a written disclosure only because it does not “disclose the
exact locations of the claimed components.” Ans. 7. However, because the
original Specification discloses the subject matter depicted in Figure 1 (and
recited in the claims, albeit without using the identical words), it was
incumbent upon the Examiner to provide a reason why one of ordinary skill
in the art would not consider the description sufficient. In re Alton, 76 F.3d
1168, 1175 (Fed. Cir. 1996). The Examiner fails to provide any explanation
why a skilled artisan, which the complexity of the claims and Specification
evidence, is a highly educated individual having several years of practical
experience with lyophilization processes, would not readily recognize the
depicted configuration from the above description of known freeze-dryer
apparatuses. “If a person of ordinary skill in the art would have understood
[Appellants] to have been in possession of the claimed invention at the time
of filing, even if every nuance of the claims is not explicitly described in the
specification, then the adequate written description requirement is met.” Id.
In view of Appellants’ originally filed Specification, we are not
persuaded either the new matter objection to Figure 1 or the written
description rejection of the claims made by the Examiner is appropriate.
Therefore, we do not sustain the new matter objection to the addition of
Figure 1 or the rejection of the claims as failing to satisfy the written
description requirement.
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Rejection II (enablement)
Concluding the claims are not enabled, the Examiner identifies
multiple reasons the description of the invention in Appellants’ Specification
is inadequate to enable a skilled artisan to make and/or use the invention.
See Non-Final Act. 4—5. Many of these reasons were withdrawn by the
Examiner in the Answer, however. See Ans. 4—5. Although the Examiner’s
description of which enablement grounds are withdrawn is far from clear,
we understand the surviving enablement rejection to be premised on the
following deficiencies: (1) “[t]he specification fails to explain how the
claimed active steps based on the empirical mathematical formula,
Equations 4-3 lb will enable one skilled in the art to obtain the claimed
desired result of the end of the secondary drying phase the product is dried;”
and (2) “[t]he specification fails to explain what the values of kinetic
constants ko, ki, k2, initial conditions Cs,o are” and “how to estimate initial
conditions Cs,o, kinetic constants ko, ki, k2, final time, etc.” Ans. 3.
We conclude the Examiner’s first alleged deficiency is unfounded
because it is not commensurate with the scope of the claims. In particular,
the claims do not recite a “desired result” and the Examiner does not identify
any claim language suggesting otherwise. Instead, the claims recite a
“[mjethod for calculating a residual moisture concentration and/or
desorption rate of a product during a secondary drying phase of a freeze-
drying process in a freeze-dryer apparatus.” Br. 23, 30 (Claims App.). We
agree with Appellants “that the presently claimed invention is directed to a
method for monitoring (not controlling) the secondary drying process step
within a complete lyophilization process.” Id. at 8.
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Application 12/502,863
We also conclude the Examiner’s second alleged deficiency is in error
because the Examiner does not provide any basis to explain why a skilled
artisan would not be able to make the necessary estimates for the initial
conditions Cs,0, kinetic constants ko, ki, k2, final time, etc. without an undue
amount of experimentation. Instead, Appellants’ Specification teaches
expressly a series of steps for “calculating [the] initial condition Cs,0 and
kinetic constants.” Spec. 13—24. In particular, step 4 explains how the
initial condition Cs,0 and kinetic constants are estimated. See id. at 14—15.
The Examiner fails to explain what, if anything, is inadequate about step 4 to
allow a skilled artisan to perform the claimed methods, or why a skilled
artisan would still be subjected to undue experimentation in view of this
description.
Therefore, in view of the foregoing, we do not sustain the Examiner’s
rejection for lack of enablement.
Rejection III (indefiniteness)
Concluding the claims are indefinite, the Examiner identifies multiple
reasons the language of independent claims 18 and 19 is unclear. See Non-
Final Act. 5—6. Many of these reasons were again withdrawn by the
Examiner in the Answer, however. See Ans. 5. Although the Examiner’s
description of which indefmiteness grounds are withdrawn is far from clear,
we understanding the Examiner’s conclusion to be based on the finding that
the Specification “is unclear how to estimate initial conditions, kinetic
constants, etc.,” which are essentially the same reasons the Examiner
concluded the claims are not enabled (see supra Rejection II). Ans. 10.
Notably, the Examiner does not assert a skilled artisan would not
understand the meaning of any particular claim language, but instead
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contends “[i]t is not clear what the metes and bounds of the claimed Steps
a-g are due to the guesswork of the initial values of constants CS)0, ko, ki and
k2” Ans. 10. For similar reasons discussed above in Rejection II addressing
enablement, we are unpersuaded the Examiner has made a proper showing
of indefiniteness. Specifically, the Examiner fails to explain why the
description in Specification, at pages 13—24, is deficient in explaining to a
skilled artisan how the estimated values for the initial conditions and kinetic
constants are derived or obtained in the claimed process. The Examiner,
moreover, does not contend that any ambiguity exists with what any of the
claim language means or what the recited variables represent. Therefore, we
do not sustain the Examiner’s indefmiteness rejection.
DECISION
The Examiner’s rejections of claims 18—27 and 29—35 are reversed.
REVERSED
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