Ex Parte McGill et al

Patent Trial and Appeal Board

Feb 1, 2016

10544736 (P.T.A.B. Feb. 1, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
10/544,736 10/12/2006
36335 7590
GE Healthcare, Inc,
9900 W. Innovation Drive
RP 2131
Wauwatosa, WI 53226
02/03/2016
FIRST NAMED INVENTOR
David McGill
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.
PZ0314 5333
EXAMINER
PERREIRA, MELISSA JEAN
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
02/03/2016 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 DAVID MCGILL and INGRID HENRIKSEN
Appeal2013-005229
Application 10/544,736
Technology Center 1600
Before DEMETRA J. MILLS, ERIC B. GRIMES, and RICHARD J.
SMITH, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
Appeal 2013-005229
Application 10/544,736
STATEMENT OF CASE
According to the Specification, page 1, the invention relates to
"stabilised technetium and rhenium metal complex compositions comprising
a radioprotectant and a radiometal complex of a tropane-tetradentate
chelating agent conjugate" and "[ r ]adiopharmaceuticals comprising the
stabilised metal complex compositions."
The following claim is representative.
29. A composition comprising:
(i) a conjugate of Formula Ia:
[ { tropane }-(A )n]m-[ tetradentate chelating agent] (Ia)
wherein:
(a) the tropane has the Formula III:
~
N
(Ill)
wherein:
R1 is H, C1_4 alkyl, C1_4 alkenyl or C1_4 fluoroalkyl;
R2 is C02R5, CON(R5) 2, COR5 or C1_4 alkyl, where each
R5 is independently H or C1_3 alkyl; and
R3 and R4 are independently H, Cl, Br, F, I, CH3, CF3,
N02, OCH3 or NH2;
(b) -(A)n- is a linker group wherein each A is independently -
CR2-, -CR=CR-, -C=C-, -CR2C02-, -C02CR2-, -NRCO-
' -CONR- , -NR(C=O)NR-, -NR(C=S)NR-, -S02NR- , -
NRS02- , -CR20CR2- , -CR2SCR2- , -CR2NRCR2- , a C4-s
cycloheteroalkylene group, a C4_s cycloalkylene group, a
Cs-12 arylene group, or a C3-12 heteroarylene group;
each R is independently H, C1_4 alkyl, C2_4 alkenyl, C2_4 alkynyl,
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Application 10/544,736
C1_4 alkoxyalkyl or C1_4 hydroxyalkyl; n is an integer of value 0 to
10; and, mis 1, 2 or 3; and
( c) the tetradentate chelating agent comprises a donor set
comprising N2S2; N3S; diaminedioxime, or amidetriamine,
wherein said
tetradentate chelating agent is complexed with a radioactive
isotope of technetium or rhenium; and
(ii) at least one radioprotectant.
Cited References
Winchell
Kung et al.
Liu
us 4,364,920
us 5,980,860
US 6,713,042 B2
Dec. 21, 1982
Nov. 9, 1999
Mar. 30, 2004
S. R. Choi et al., An Improved Kit Formulation of a Dopamine Transporter
Imaging Agent: [Tc-99M]TRODAT-l, 26 NucL. MED. BIOL. 461--466
(1999).
Grounds of Rejection
3-10.
1. Claims 4--6, 8-14, 16-24, 26, 28, and 29 are rejected under 35
U.S.C. § 103(a) as being unpatentable over Kung in view of
Winchell and Liu.
2. Claims 4--6, 8-14, 16-24, 26, 28, and 29 are rejected under 35
U.S.C. § 103(a) as being unpatentable over Choi in view of
Winchell and Liu.
FINDINGS OF FACT
The Examiner's findings of fact are set forth in the Answer at pages
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Application 10/544,736
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Rejection 1
We agree with the Examiner's fact finding, statement of the rejection
and responses to Appellants' arguments as set forth in the Answer. We find
that the Examiner has provided evidence to support a prima facie case of
obviousness. We provide the following additional comment to the
Examiner's argument set forth in the Final Rejection and Answer.
Appellants contend that the Examiner's reasoning in support of the
rejection and motivation to combine references as set forth in the Answer is
invalid because in the field of 99mTc radiopharma-
ceuticals, a radioprotectant is not used in all 99mTc-chelator
preparations in practice. A radioprotectant is used only under
certain circumstances, when there is a reason to do so - i.e. that
the 99mTc complex is known to be unstable. Appellant stresses
that the ordinary person skilled in the art knows readily whether
a given 99mTc complex is stable over time or not - it is a simple
matter of carrying out quality control at various time points
post-preparation.
Br. 4. Appellants argue that this is evidenced by the fact that Winchell's
"use of stabilizers clearly refers to 99mTc metal complexes which were
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Application 10/544,736
known to 'deteriorate substantially in 24 hours' when exposed to the
atmosphere." Id. at 5.
We are not persuaded. The prior art here discloses that it was known
to those of ordinary skill in the art at the time of the invention to use
stabilizers with diagnostic reagents comprising a chelating agent and
stannous tin which are suitable for conversion to radiopharmaceuticals.
Winchell, abstract. The diagnostic agents include suitable forms of
technetium 99m. Id. The diagnostic compositions of Winchell are
stabilized against oxidation and/or hydrolysis by the addition of ascorbic
acid, for example. Id. Appellants admit that "the ordinary person skilled in
the art knows readily whether a given 99mTc complex is stable over time or
not - it is a simple matter of carrying out quality control at various time
points post-preparation." Br. 4.
Appellants further argue that the disclosure of Winchell is limited to
99mTc metal complexes which were known to "deteriorate substantially in 24
hours." Br. 5. Appellants provide no evidence to support such a proposition
that the disclosure of Winchell is limited to the situation of 99mTc metal
complexes which were known to deteriorate. Nor do appellants provide
specific evidence that Winchell's inclusion of a radioprotectant is not
applicable generally to 99mTc metal complexes. In particular, Winchell
discloses generally that
Failure to effectively remove all oxidants, or the presence of
residual water in the preparation after lyophilization, however,
may result in the slow oxidation of the reducing agent
and eventual failure of the reagent. An obvious expeditious
solution to the problem would be to increase the
concentration of the reducing agent thereby allowing
for some loss in reducing power without losing the
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Application 10/544,736
effectiveness of the reagents. This solution, however, is
often undesirable wherein stannous ions are utilized as
the reducing agent, since the potential for toxic manifestations
increases as the concentration of the reagent administered to the
patient is increased.
Col. 1, 11. 19-31. The motivation to combine references does not have to be
identical to the applicants' to establish obviousness. In re Kemps, 97 F.3d
1427, 1430 (Fed. Cir. 1996). Here, Winchell discloses a reason to stabilize
similar diagnostic compositions against oxidation and/or hydrolysis with the
inclusion of a radioprotectant. The obviousness rejection is affirmed for the
reasons of record.
Rejection 2
With respect to rejection 2 as set forth in the grounds of rejection
above (Choi in view of Winchell and Liu), "Appellants refer to the
argumentation above in response to the obviousness rejection of the claims
over Kung in vie\v of \Vinchell and in fhrther vie\v of Liu. The alleged
motivation based on Winchell does not in fact exist for the same reasons
given above." Br. 13.
We were unpersuaded by Appellants' arguments as set forth with
respect to rejection 1 above, and for this reason, rejection 2 is also affirmed.
CONCLUSION OF LAW
The cited references support the Examiner's obviousness rejections,
which are affirmed. All pending claims fall.
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TIME PERIOD
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
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