Ex Parte Wickstrom et al

Patent Trial and Appeal Board

Sep 26, 2016

11721563 (P.T.A.B. Sep. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111721,563 0610412009
132118 7590
Wood IP LLC - GEHC LS
555 Quince Orchard Road
Suite 280
Gaithersburg, MD 20878
09/28/2016
FIRST NAMED INVENTOR
Lill Torild Wickstrom
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.
PN0476 1262
EXAMINER
CRAIGO, BAHAR ALA WI
ART UNIT PAPER NUMBER
1673
NOTIFICATION DATE DELIVERY MODE
09/28/2016 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):
docketing@woodiplaw.com
wood_PAIR@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LILL TORILD WICKSTROM,
DIRK-JAN IN'T VELD, NIGEL JOHN OSBORN,
JULIAN GRIGG, and ANTHONY WILSON
Appeal2015-004034
Application 11/721,563
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
TA WEN CHANG, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving a method for
improving stability of mannose triflate. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Parties in Interest as GE Healthcare
Limited and GE Healthcare AS, each a part of General Electric
(see Br. 3).
Appeal2015-004034
Application 11/721,563
Statement of the Case
Background
"Non fluoridated sugar derivatives such as l ,3,4,6-tetra-O-acetyl-2-0-
trifluoromethanesulfonyl-~-D-mannopyranose (commonly known as
mannose triflate) are currently supplied commercially as dry powders and
need to be stored at sub-ambient temperatures to ensure stability over a
reasonable period" (Spec. 1, 11. 11-14).
According to the Specification, "[t]he present inventors have
surprisingly found that by storing a non fluoridated sugar derivative, such as
mannose triflate in an organic solvent rather than as a dry powder, the
stability is improved" (Spec. 1 :25-27).
The Claims
Claims 1, 7-9, and 18-22 are on appeal. Claim 1 is representative and
reads as follows:
1. A method for improving stability of l,3,4,6-tetra-O-
acetyl-2-0-trifluoromethanesulfonyl-~-D-mannopyranose
comprising the step of storing said l,3,4,6-tetra-O-acetyl-2-0-
trifluoromethanesulfonyl-~-D-mannopyranose in acetonitrile
solvent at a concentration of 1 Omg/ml to 18mg/ml in a sealed
container.
The Issues
A. The Examiner rejected claim 1under35 U.S.C. § 103(a) as obvious
over Nakazawa2 (Final Act. 3--4).
2 Nakazawa et al., US 5,759,513, issued June 2, 1998
("N akaza wa").
2
Appeal2015-004034
Application 11/721,563
B. The Examiner rejected claim 9 under 35 U.S.C. § 103(a) as obvious
over Nakazawa and ABX3 (Final Act. 5-7).
C. The Examiner rejected claims 7, 18, and 19 under 35 U.S.C. § 103(a)
as obvious over Nakazawa and Hamacher4 (Final Act. 8-10).
D. The Examiner rejected claims 8 and 20-22 under 35 U.S.C. § 103(a)
as obvious over Nakazawa and Coenen5 (Final Act. 11-13).
A. 35 U.S.C. § 103 over Nakazawa
The Examiner finds that "Nakazawa teaches opening a valve to
transfer a solution containing 20 mg ... mannose triflate ... in 1 ml
acetonitrile that was contained in container K ... thus the concentration of
the mannose triflate is 20 mg/ml" (Final Act. 3). The Examiner
acknowledges that "Nakazawa does not expressly disclose the concentration
of man[ n Jose triflate between 10 mg/ml to 18 mg/ml" but finds that
"[ m ]odification of the concentration of mannose triflate in acetonitrile is
well within the level of ordinary skill in the art" (Final Act. 3--4).
3 ABX advanced biochemical compounds, "Mannose triflate, ultra
pure" datasheet, http://web.archive.org/web/20041220180627
/http://www.abx.de/chemicals/100.html (2004) ("ABX").
4 Hamacher et al., Computer-aided Synthesis (CAS) of No-carrier-
added 2-{18F}Fluoro-2-deoxy-D-glucose: an Efficient Automated
System for the Aminopolyether-supported Nucleophilic
Fluorination, 41 INT. J. RADIATION APPLICATIONS AND
INSTRUMENTATION: PART A 49-54 (1990) ("Hamacher").
5 Coenen et al., US 4,794,178, issued Dec. 27, 1988 ("Coenen").
3
Appeal2015-004034
Application 11/721,563
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Nakazawa renders claim 1
obvious?
Findings of Fact
1. The Specification teaches that
the non fluoridated sugar derivative is present in the solvent,
suitably an aprotic solvent at a concentration suited for
performing a subsequent radiofluoridation reaction, for example
from 0.1 mg/ml to 50mg/ml, more suitably 5mg/ml to 25mg/ml,
even more suitably 1 Omg/ml to 18mg/ml. In one particular
embodiment, the non fluoridated sugar derivative is present in
the solvent, suitably an aprotic solvent at a concentration of
15mg/ml. In a further embodiment, the non fluoridated sugar
derivative is present in the solvent, suitably an aprotic solvent at
a concentration of 17.5 to 21.5mg/ml.
(Spec. 3:8-15).
2. The Specification teaches that "[ s ]uitable aprotic solvents for
this purpose include acetonitrile" (Spec. 2:22).
3. Nakazawa teaches that a "cock 14 is opened to transfer a
solution of 20 mg of 1,3,4,6-tetra-O-acetyl-2-0-trifluoromethane-sulfonyl-f3-
D-mannopyranose in 1 ml of acetonitrile, which is contained in a container
K, to the reaction vessel S. The cock 14 is closed" (Nakazawa 5:25-28).
4. Nakazawa teaches that "raw materials are desirably liquid ...
The individual raw materials and intermediate products are transferred by
means of a nonreactive gas for force feed and pressure reduction. Such
transfer is controlled by opening and/or closing shut-off cocks provided in
the individual connections" (Nakazawa 3:36-44).
4
Appeal2015-004034
Application 11/721,563
Principles of Law
"Normally, it is to be expected that a change ... in concentration ...
would be an unpatentable modification .... More particularly, where the
general conditions of a claim are disclosed in the prior art, it is not inventive
to discover the optimum or workable ranges by routine experimentation." In
re Aller, 220 F.2d 454, 456 (CCPA 1955).
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 3--4; FF 1--4) and agree that the
claims are rendered obvious by Nakazawa. We address Appellants'
arguments below.
Appellants contend that
by storing the sugar derivative in acetonitrile at a specific
concentration in a sealed container ... the sugar derivative
can be stored for extended periods of time as a solution in
acetonitrile. As set forth in Example 1 of Appellants'
specification, storage of the sugar derivative as a dry powder
(i.e., without the use of Appellants' claimed invention) resulted
in the sample turning black and smelling strongly of acetic acid.
This unexpected result is not taught or suggested by the cited
references.
(Br. 5).
We find this argument unpersuasive because the comparison between
acetonitrile-stored mannose triflate and dry powder-stored mannose triflate
fails to compare the process to the closest prior art ofNakazawa. Nakazawa
teaches that the raw materials are stored in liquid form in containers sealed
with shut-off cocks (FF 4) and specifically teaches that a 20 mg/ml solution
of mannose triflate in acetonitrile is stored, at least temporarily, in a
5
Appeal2015-004034
Application 11/721,563
container K (FF 3). See In re Baxter Travenol Labs., 952 F.2d 388, 392
(Fed. Cir. 1991) ("[W]hen unexpected results are used as evidence of
nonobviousness, the results must be shown to be unexpected compared with
the closest prior art."). Thus, the evidence of record does not establish that
the storage conditions provide an unexpected result.
Appellants contend that
Nakazawa is wholly unconcerned with the problem addressed
by Appellants' claimed invention .... N akazawa does not teach
or suggest the use of a sealed container as in Appellants'
claimed invention, as it is not concerned with storage but rather
improving/shortening preparation times. Nakazawa does not
teach or suggest Appellants' claimed invention. Appellants'
claimed invention is not obvious in view of the cited
reference[].
(Br. 5).
We do not find this argument persuasive because the "neither the
particular motivation nor the avowed purpose of the patentee controls. What
matters is the objective reach of the claim. If the claim extends to what is
obvious, it is invalid under§ 103." KSR Int'! Co. v. Teleflex Inc., 550 U.S.
398, 419 (2007). In this case, the difference between Nakazawa and the
claimed invention is that Nakazawa stores 20 mg/ml of mannose triflate in
acetonitrile while the claims are limited to a range of 10 to 18 mg/ml of
mannose triflate in acetonitrile. The Specification states that ranges of
mannose triflate overlapping 20 mg/ml are suitable, including specific
ranges as narrow as 17 .5 to 21.5 mg/ml (FF 1 ). As already discussed,
Appellants provide no unexpected results compared to the disclosure of
Nakazawa and "a prima facie case of obviousness exists when the claimed
6
Appeal2015-004034
Application 11/721,563
range and the prior art range do not overlap but are close enough such that
one skilled in the art would have expected them to have the same
properties." In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).
Appellants provide no reason or evidence to suggest that the ordinary artisan
would have expected any difference in properties between 18 mg/ml and 20
mg/ml mannose triflate solutions in acetonitrile.
Conclusions of Law
The evidence of record supports the Examiner's conclusion that
Nakazawa renders claim 1 obvious.
B-D. 35U.S.C.§103
Appellants do not separately argue the obviousness rejections directed
towards the dependent claims, instead relying upon their arguments to
overcome Nakazawa. The Examiner provides sound fact-based reasoning for
combining Nakazawa with ABX, Hamacher, and Coenen (see Final Act. 5-
13). Having affirmed the obviousness rejection of claim 1 over Nakazawa
for the reasons given above, we also find that the further obvious
combinations with ABX, Hamacher, and Coenen render the dependent
claims obvious for the reasons given by the Examiner.
SUMMARY
In summary, we affirm the obviousness rejections
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
7