Ex Parte JOHNSEN et al

Patent Trial and Appeal Board

Oct 9, 2014

12621551 (P.T.A.B. Oct. 9, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte HANNE JORUNN H. JOHNSEN, LARS TERJE HOLMAAS, and
OLE MAGNE HOMESTAD
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Appeal 2014-004049
Application 12/621,551
Technology Center 1600
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Before DONALD E. ADAMS, ERIC B. GRIMES, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL1
This appeal2 under 35 U.S.C. § 134 involves claims 1–4 (App. Br. 3).
Examiner entered rejection under 35 U.S.C. § 103(a). We have jurisdiction
under 35 U.S.C. § 6(b).
We reverse.

1 The Real Party in Interest is GE Healthcare, Inc. a part of General Electric
(“GE”) (App. Br. 3).
2 This Appeal is related to Appeal 2012-001715, Application 12/621,551
(see Br. 5 (“[i]n the . . . Patent Trial and Appeal Board Decision dated
November 20, 2012”); Cf. Br. 3 (“There are no other appeals or interferences
related to the instant appeal”)).
Appeal 2014-004049
Application 12/621,551

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STATEMENT OF THE CASE
The claims are directed to a process for the dimerization of 5-
acetamido-N,N’-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-isophthalamide
(Compound A). Claim 1 is representative and is reproduced in the Claims
Appendix of Appellants’ Brief.
Claims 1–4 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Homestad,3 and Malthe-Sørenssen.4
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion that the combination of Homestad and Malthe-Sørenssen
suggests a process for the dimerization of Compound A, wherein the pH is
varied throughout the dimerization having a higher value at the start of the
dimerization than at the end thereof?
FACTUAL FINDINGS (FF)
FF 1. Homestad suggest “a process for the preparation of . . . Compound A
in which, after the dimerization step, unreacted Compound A is precipitated
from the reaction mixture and recovered for re-use” (Homestad, col. 4, ll.
33–36) (emphasis added).
FF 2. Homestad suggests that the
Precipitation of Compound A from a non-aqueous
reaction mixture can be effected after addition of water . . . . If
water is present in the reaction mixture, the amount of water
added for precipitation can be reduced accordingly. An
alcoholic co-solvent . . . may additionally be used . . . . In some
instances, traces of undissolved material remain after the
addition of water and alcohol and these can be dissolved by

3 Homestad, US 6,974,882 B2, issued Dec. 13, 2005.
4 Malthe-Sørenssen et al., US 6,232,499 B1, issued May 15, 2001.
Appeal 2014-004049
Application 12/621,551

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addition of alkali, e.g. sodium hydroxide. The pH of the
solution is then adjusted to about 10–11 by addition of an acid .
. . to provoke precipitation of unreacted Compound A and if
necessary the temperature can be adjusted to 15–40 C.,
preferably 18–30 C. The solution is optionally seeded with
crystals of Compound A to initiate the precipitation of
Compound A, while the iodixanol formed stays in solution.
(Id. at 47–65) (emphasis added.)
ANALYSIS
Appellants’ claimed dimerization process requires, inter alia, that “the
pH is varied throughout the dimeri[z]ation having a higher value at the start
of the dimeri[z]ation than at the end thereof” (see Appellants’ independent
claim 1). Examiner does not dispute Appellants’ contention that Malthe-
Sørenssen “does not provide any teaching or suggestion as to the varying of
the pH throughout the dimerization, whereby the pH has a higher value at
the start of the dimerization than at the end thereof” (Br. 5). Instead,
Examiner finds that “Homestad necessarily changes pH during the
dimerization step in order to provoke precipitation, see Homestad, col. 4,
ll. 58-62 (“[t]he pH of the solution is then adjusted to about 10-11 by
addition of an acid, e.g., hydrochloric acid, to provoke precipitation of
unreacted Compound A . . .)” (Ans. 16–17 (emphasis and alteration
original)). We are not persuaded.
Notwithstanding Examiner’s assertion to the contrary, Homestad
suggests the dimerization of Compound A and then, after the dimerization
step, unreacted Compound A is precipitated from the reaction mixture (FF
1–2; see also Br. 4 (“all reference in Homestad to pH values relates to the
second step of the procedure, i.e., the precipitation step and not the
dimerization step”)).
Appeal 2014-004049
Application 12/621,551

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In sum, Examiner failed to establish that the combination of
Homestad and Malthe-Sørenssen suggests a process for the dimerization of
Compound A, wherein the pH is varied throughout the dimerization having a
higher value at the start of the dimerization than at the end thereof, as is
required by Appellants’ claimed invention.
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion that the combination of Homestad and Malthe-
Sørenssen suggests a process for the dimerization of Compound A, wherein
the pH is varied throughout the dimerization having a higher value at the
start of the dimerization than at the end thereof. The rejection of claims 1–4
under 35 U.S.C. § 103(a) as unpatentable over the combination of Homestad
and Malthe-Sørenssen is reversed.

REVERSED

cdc