Ex Parte Gacek et al

Patent Trial and Appeal Board

Jan 13, 2016

12095923 (P.T.A.B. Jan. 13, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/095,923 06/03/2008
36335 7590
GE Healthcare, Inc,
9900 W. Innovation Drive
RP 2131
Wauwatosa, WI 53226
01/15/2016
FIRST NAMED INVENTOR
Michel Gacek
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.
PZ05109 6809
EXAMINER
DONOHUE, SEAN R
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
01115/2016 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):
hctechnologies@ge.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHEL GACEK,
HANNO PRIEBE, and NIGEL JOHN OSBORN
Appeal2013-007250
Application 12/095,923
Technology Center 1600
Before DONALD E. ADAMS, MELANIE L. McCOLLUM, and
ULRIKE W. JENKS, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL 1
This appeal under 35 U.S.C. § 134(a) involves claims 1-14 (see Br.
3). Examiner entered a rejection under 35 U.S.C. § 103(a). We have
jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
STATEMENT OF THE CASE
Appellants' disclosure relates to "a method for the preparation of
radioisotopically-labelled imaging agent compositions" (Spec. 1: 4--5).
1 Appellants identify the Real Party in Interest as "GE Healthcare Limited"
(Br. 2).
Appeal2013-007250
Application 12/095,923
Claim 1 is representative and reproduced in the Claims Appendix of
Appellants' Brief.
Claims 1-14 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Luthra, 2 Wadsworth, 3 Han, 4 and Bayer. 5
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Luthra "relates to novel solid-phase processes for the production of
radio labeled tracers" (Luthra 1: i-f 1 ).
FF 2. Luthra's "process for the production of an 18F-labelled tracer[]
comprises treatment of a resin-bound precursor of formula (I) [:] SOLID
SUPPORT-LINKER-X-TRACER[,] with 18P- to produce the labelled tracer
of formula (II)[:] 18F-TRACER" (Luthra 1: i-fi-14--5 and 17-22; see
generally Ans. 4)
FF 3. Luthra discloses that "the 18F -labelled tracer of formula (II) is
removed from the solid-phase into solution, [therefore,] all unreacted
precursor remains bound to the resin and can be separated [from the 18F-
labelled tracer] by simple filtration, thus obviating the need for complicated
purification, for example by HPLC" (Luthra 1: i-f 6).
2 Luthra et al., US 2004/0236085 Al, published Nov. 25, 2004.
3 Wadsworth et al., US 7,935,852 B2, issued May 3, 2011.
4 Hyunsoo Han et al., Liquid-phase combinatorial synthesis, 92 Proc. Natl.
Acad. Sci. USA 6419-6423 (1995).
5 E. Bayer et al., Liquid Phase Synthesis of Peptides, 237 Nature 512-513
(1972).
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Appeal2013-007250
Application 12/095,923
FF4.
- - -- - - ,, 1Q_ - - - - - -
Luthra discloses that '"excess '°l:r may be removed from the solution
of [lJ8F-tracer by any suitable means, for example by ion-exchange
chromatography or solid phase absorbents" (Luthra i-f 23; see generally Ans.
4).
FF 5. Luthra discloses that
[b ]efore use of the 18F-labelled tracer, it may be
appropriate to formulate it, for example as an aqueous solution
by dissolving the 18F-labelled tracer in sterile isotonic saline
which may contain up to 10% of a suitable organic solvent such
as ethanol, or a suitable buffered solution such as phosphate
buffer.
(Luthra i-f 25; see generally Ans. 4.)
FF 6. Examiner finds that Luthra fails to suggest a "polymeric support
[that] is wholly soluble in reaction solution" (Ans. 6; see id. at 12-13).
FF 7. Wads worth "relates to a method for the fluoridation of iodonium
salts wherein the reaction proceeds in the presence of water" (Wadsworth 1 :
12-14; see generally Ans. 7).
FF 8. Wadsworth's method
comprises the fluoridation of an iodonium salt of Formula (I) or
(II) ·. :.i) \'··
1··
wherein:
Q is an electron deficient aromatic or heteroaromatic moiety;
each of R 1, R2, R3, R4 and R5 is independently hydrogen, ---O(C1_
10 alkyl) or C1_10 alkyl; and
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Appeal2013-007250
Application 12/095,923
y- is a counter ion [];to give a product of general formula (III):
Q-F
(Wadsworth 3: 11--42.)
(III)
FF 9. Wadsworth discloses that "[i]n the compound of Formula II, the
'solid support' may be any suitable solid-phase support which is insoluble in
any solvents to be used in the process but to which the linker can be
covalently bound" (Wadsworth 4: 12-15).
FF 10. Han discloses a liquid-phase combinatorial synthesis method for
producing combinatorial protein libraries (see generally Han 6419).
FF 11. Han discloses that
The "solid-phase" method in a combinatorial format, as
successful as it has been, still has certain drawbacks. The most
notable liability is the heterogeneous reaction conditions, which
can exhibit several of the following problems: nonlinear kinetic
behavior, unequal distribution and/or access to the chemical
reaction, solvation problems, the use of insoluble reagents or
catalysts, and pure synthetic problems associated with solid-
phase synthesis.
(Han 6419: col. 1, 11. 16-20; see Ans. 6.)
FF 12. Bayer discloses that"[ o ]ne of the most exciting recent developments
in peptide synthesis is the introduction of the solid phase method which
facilitates rapid synthesis of peptides by the elimination of tedious
purification steps. Excess reagents are removed by filtration" (Bayer 512:
col. 1, 11. 1-5 (endnote removed)).
FF 13. Bayer discloses that
[t]he principal advantage of the solid phase method is the
application and easy removal of excess reagents during the
coupling step and the possibility of mechanization. From every
other aspect, however, synthesis in solution would be more
convenient. [Therefore, Bayer] developed a liquid phase
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Appeal2013-007250
Application 12/095,923
method for peptide synthesis which combines the advantages of
the "classical" synthesis in solution with those of the solid
phase method.
(Bayer 512: col. 1, 11. 30-40 (endnote removed); see generally Ans. 6-7.)
ANALYSIS
Based on the combination ofLuthra, Wadsworth, Han, and Bayer,
Examiner concludes that, at the time Appellants' invention was made, it
would have been prima facie obvious
to modify the methods taught by Luthra [] (i.e., methods of
radiolabeling using "solid-phase" polymeric supported
conjugates) to includes the use of wholly soluble polymeric
supported conjugates as taught by Han[] and [B]ayer []because
it would provide the advantages of "liquid-phase" synthesis,
such as homogeneous solution and separation from excess
reagent, better yields and ease of automation.
(Ans. 7.) We are not persuaded.
The prior art relied upon by Examiner is not in the same field of
endeavor. Luthra and Wadsworth are directed to radio-labeling compounds
(FF 1 and 7). In contrast, Han and Bayer relate to liquid phase synthesis of
peptides (FF 10-13). Examiner failed to establish an evidentiary basis on
this record to support a conclusion that a person of ordinary skill in this art
would have looked to either of Han and Bayer to modify the radio labeling
methods suggested by Luthra and Wadsworth (see Br. 6).
We recognize, but are not persuaded by, Examiner's assertion "that
Luthra teaches peptide synthesis because Luthra teaches labeling peptides or
proteins [] using chemical synthesis" (Ans. 11 ). Examiner, however, failed
to identify an evidentiary basis on this record to support a conclusion that a
person of ordinary skill in this art would have considered Luthra's method of
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Appeal2013-007250
Application 12/095,923
labeling peptides or proteins to represent protein or peptide synthesis within
the scope of Han or Bayer.
Further, as Appellants' explain, "the principal advantages
acknowledged by Bayer [] for solid phase synthesis[, i.e. the application and
easy removal of excess reagents,] are precisely the same reasons why Luthra
[]/Wadsworth [] chose the solid phase approach" for their radiolabeling
methods (Br. 7; see FF 13; see e.g., FF 3 ("the 18F-labelled tracer of formula
(II) is removed from the solid-phase into solution, [therefore,] all unreacted
precursor remains bound to the resin and can be separated [from the 18F-
labelled tracer] by simple filtration, thus obviating the need for complicated
purification, for example by HPLC")). Thus, "Examiner's modification of
Luthra []would clearly 'change the principle of operation of [Luthra's
method]"' (Br. 8).
As to Han, Examiner failed to establish that the methodology
suggested by Luthra and Wadsworth suffers from the same "liability" Han
intended to overcome, specifically "heterogeneous reaction conditions,
which can exhibit several of the following problems: nonlinear kinetic
behavior, unequal distribution and/or access to the chemical reaction,
solvation problems, the use of insoluble reagents or catalysts, and pure
synthetic problems associated with solid-phase synthesis" (see FF 11 ).
At best, Examiner looks to Appellants' Specification to establish a
nexus between the methodology suggested by Luthra and Wadsworth and
that of Han and Bayer (see Ans. 15-16; cf Br. 8 ("Appellants submit that
without using hindsight teaching of [t]he currently claimed invention, a
skilled person will not look to Han[] and [Ba]yer [],since Luthra []did not
have a problem to be solved")).
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Appeal2013-007250
Application 12/095,923
To imbue one of ordinary skill in the art with knowledge of the
invention[], when no prior art reference or references of record
convey or suggest that knowledge, is to fall victim to the
insidious effect of a hindsight syndrome wherein that which
only the inventor taught is used against its teacher.
W.L. Gore &Assocs., Inc. v. Garlock, Inc., 721F.2d1540, 1553 (Fed. Cir.
1983).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness. The rejection of claims 1-14 under
35 U.S.C. § 103(a) as unpatentable over the combination of Luthra,
Wads worth, Han, and Bayer is reversed.
REVERSED
dm
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