Ex Parte Knight Castro et al

Board of Patent Appeals and Interferences

Feb 1, 2012

10510454 (B.P.A.I. Feb. 1, 2012)

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.
10/510,454 10/04/2004 Hector Knight Castro 1483 WO/US 2287
7590 02/02/2012
Tim A Cheatham
Mallinckrodt Inc
675 McDonnell Boulevard
PO Box 5840
St Louis, MO 63134
EXAMINER
PERREIRA, MELISSA JEAN
ART UNIT PAPER NUMBER
1618
MAIL DATE DELIVERY MODE
02/02/2012 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte HECTOR KNIGHT CASTRO and PETRUS SIMON
__________

Appeal 2011-000645
Application 10/510,454
Technology Center 1600
__________

Before DEMETRA J. MILLS, MELANIE L. McCOLLUM, and STEPHEN
WALSH, 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).
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Application 10/510,454

2
STATEMENT OF THE CASE
1. A method for improving radiostability of a
18
F-fluor-deoxy-glucose (
18
F-
FDG)-solution during autoclaving, the method comprising:
a) providing a
18
F-fluor-deoxy-glucose (
18
F-FDG)-solution,
b) adding at least one buffer based on a weak acid to the
18
F-fluor-
deoxy-glucose (
18
F-FDG)-solution, wherein the buffer is selected from the
group consisting of citrate, acetate, ascorbate and combinations thereof; and,
c) autoclaving the buffered
18
F-fluor-deoxy-glucose (
18
F-FDG)-
solution.

Cited References

The Examiner relies on the following prior art references:

Manual and Operating Instructions, Nuclear Interface GmbH, including the
Supplement FDG Synthesizers (2001).
Damhaut et al. US 6,172,207 B1 Jan. 9, 2001
Asai et al. US 5,536,491 Jul. 16,1996
Stone-Elander et al. US 5,308,944 May 3,1994

Grounds of Rejection
 Claims 1, 2, 5 and 16-18 are rejected under 35 U.S.C. § 103(a) over
Manual and Operating Instructions in view of Damhaut and Asai as
evidenced by Stone-Elander.
FINDINGS OF FACT
The Examiner‟s findings of fact are set forth in the Answer at pages 3-9.

ISSUE
The Examiner concludes that
At the time of the invention it would have been obvious to one
ordinarily skilled in the art to substitute the citrate buffer of
D[a]mhaut et al. for another known analogous buffer disclosed in the
Manual and Operating Instructions for the method of improving the
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Application 10/510,454

3
stability of a FDG solution. . . . At the time of the invention it would
have been obvious to one skilled in the art to use the known
sterilization method of autoclaving a fluorine substituted contrast
agent solution which is taught by Asai et al. with predictable results,
such as providing a sterilized solution for the NMR/MRI imaging, as
Dumhaut et al. teaches sterilization of 18F-FDG. The 18F isotope is
stable against high temperature (as evidenced by Stone-Elander et al.,
see fig. 7; column 2, lines 22-25) and therefore will be capable of
being successfully autoclaved/sterilized and maintain radiochemical
purity after being autoclaved. FGD is also stable at a temperature of
135 degrees (where the specification teaches of an autoclave
temperature of 134 degrees (spec, p4, line 1)) as evidenced by the
Manual and Operating Instructions and therefore it would have been
obvious to one ordinarily skilled in the art to autoclave 18F-FDG in a
citrate buffer of Dumhaut et al. up to and including 135 degrees as
The Manual and Operating Instructions teaches heating FDG up to
135 degrees.

(Ans. 4-5.)

Appellants argue that the Patent Office has not established that the
Manual and Operating Instructions is prior art or that it has been
disseminated and made available to the public. (See App. Br. 3-4.)
The issues are: Has the Examiner established that the Manual and
Operating Instructions is available as prior art? Has the Examiner set forth a
prima facie case that the cited prior art teaches the invention as claimed?

PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness.” In re
Rijckaert, 9 F. 3d 1531, 1532 (Fed. Cir. 1993) (citations omitted). See Hyatt
v. Dudas, 492 F.3d 1365, 1369 (Fed. Cir. 2007)(“In the prosecution of a
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Application 10/510,454

4
patent, the initial burden falls on the PTO to set forth the basis of any
rejection, i.e., a prima facie case.”).
“Only if that burden is met, does the burden of coming forward with
evidence or argument shift to the applicant.” Rijckaert at 1532. In order to
determine whether a prima facie case of obviousness has been established,
we consider the factors set forth in Graham v. John Deere Co., 383 U.S. 1,
17 (1966): (1) the scope and content of the prior art; (2) the differences
between the prior art and the claims at issue; (3) the level of ordinary skill in
the relevant art; and (4) objective evidence of nonobviousness, if present.
“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’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
[A] document may be deemed a printed publication
upon a satisfactory showing that it has been disseminated or
otherwise made available to the extent that persons interested
and of ordinary skill in the subject matter or art, exercising
reasonable diligence can locate it and recognize and
comprehend therefrom the essentials of the claimed invention
without need of further research or experimentation.

Massachusetts Inst. of Tech. v. AB Fortia, 774 F.2d 1104, 1109,
(quoting In re Wyer, 655 F.2d 221, 226, 210 USPQ 790, 794 (CCPA
1981)).

The statutory phrase „printed publication‟ has been interpreted to
mean that before the critical date the reference must have been
sufficiently accessible to the public interested in the art; dissemination
and public accessibility are the keys to the legal determination
whether a prior art reference was „published.‟ . . . Accessibility goes
to the issue of whether interested members of the relevant public
could obtain the information if they wanted to. If accessibility is
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proved, there is no requirement to show that particular members of the
public actually received the information.

Constant v. Advanced Micro-Devices Inc., 848 F.2d 1560, 1569, 7 USPQ2d
1057, 1062-63 (Fed. Cir. 1988).

Because there are many ways in which a reference may be
disseminated to the interested public, „public accessibility‟ has been
called the touchstone in determining whether a reference constitutes a
„printed publication‟ bar under 35 U.S.C. § 102(b). . . . The proponent
of the publication bar must show that prior to the critical date the
reference was sufficiently accessible, at least to the public interested
in the art, so that such a one by examining the reference could make
the claimed invention without further research or experimentation.

In re Hall, 781 F.2d 897, 898-899 (Fed. Cir. 1986).

ANALYSIS
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Rijckaert at
1532. We do not find that that burden has been met by the Examiner in this
case, as the Examiner has failed to show that the Manual and Operating
Instructions is a printed publication which was publically available to those
of ordinary skill in the art by the critical date.
The Examiner argues that Appellants have indicated several scenarios
in which the Manual may not be a printed publication, however the
Examiner finds these scenarios to be merely hypothetical. The fact that the
scenarios presented by Appellants may be hypothetical does not dispel the
Examiner‟s burden in the first instance to establish that the Manual was
publically available or disseminated.
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While we are mindful that evidence of a routine business practice may
be used to establish that a printed publication was available, we have no
evidence of this nature before us, for example, evidence showing that the
PET-Radiopharmaceutical dispensing unit associated with the Manual was
actually sold. Compare, Constant v. Advanced Micro-Devices Inc., 848 F.2d
1560, 1569 (Fed. Cir. 1988).
Furthermore, the Examiner has not established on the record before us
that the obviousness rejection would stand without the Manual, using only
the Damhaut and Asai references. The Examiner has not responded in the
Answer to Appellants‟ arguments that the rejection based on Damhaut and
Asai would not stand because the order of steps is critical to their invention.
(See App. Br. 8-9.)
In view of the above, the obviousness rejection is reversed.

CONCLUSION OF LAW
On the record before us, the Examiner has not established that the
Manuel is prior art or that the other cited references support the Examiner‟s
obviousness rejection.

REVERSED
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