Ex Parte Beer et al

Patent Trial and Appeal Board

Jul 7, 2016

11995693 (P.T.A.B. Jul. 7, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111995,693 08/20/2008
36335 7590
GE Healthcare, Inc.
9900 W. Innovation Drive
RP 2131
Wauwatosa, WI 53226
07111/2016
FIRST NAMED INVENTOR
PaulD. Beer
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.
PZ0552 9965
EXAMINER
SAMALA, JAGADISHW AR RAO
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
07/11/2016 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
Exparte PAUL D. BEER, MICHAEL LANKSHEAR,
HEMA DATTANI, ALEX JACKSON, and MICHELLE A VORY
Appeal2013-008995
Application 11/995,693
Technology Center 1600
Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
KRISTI L. R. SA WERT, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL 1
This appeal under 35 U.S.C. § 134(a) involves claims 1-17 (see App.
Br. 2). Examiner entered 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' "invention relates to radio labeled nanoparticles having a
radioisotope non-covalently bonded thereto" (Spec. 1 ). Claim 1 is
representative and reproduced in the Claims Appendix of Appellants' Brief.
1 Appellants identify the Real Parties in Interest as GE Healthcare Limited
and University of Oxford (Br. 1 ).
Appeal2013-008995
Application 11/995,693
Claims 1-17 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Salafsky,2 Hainfeld,3 and Kotov. 4
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Examiner finds that Salafsky discloses Appellants' claimed
invention with the exception of "at least one radioisotope which is non-
covalently bonded to [a] nanoparticle" (Ans. 5 and 7).
FF 2. Hainfeld discloses metal nanoparticles having a core composed of,
inter alia, gold, palladium or silver and a lipid surface layer, that includes an
organothiol, wherein the surface layer "may include a radioactive isotope"
(Hainfeld, col. 5, 1. 8; see id. at cols. 21-22 (claims 1 and 16); Ans. 5 and 7-
9).
FF 3. Hainfeld discloses that the surface layer may be "adsorbed and held
by non-covalent forces, such as van der Waals attraction, charge, or
hydrophobic interactions" (Hainfeld, col. 9, 11. 52-54; see also id. at col. 21
(claims 1 and 6); Ans. 5 and 7-9).
FF 4. Kotov discloses that:
Incorporation of a radiometal label into the protein structure by
using nitrogen and sulfur atoms of aminoacids (NS systems) is
very popular for technetium and rhenium. Comparative
stability of these chelates is quite high. Importantly, metal
species can be incorporated in an anionic form that makes
recomplexation by native proteins less probable. Nevertheless,
2 Salafsky, US 2004/0146460 Al, published July 29, 2004.
3 Hainfeld et al., US 6,818,199 Bl, issued Nov. 16, 2004.
4 Kotov, US 2002/0015679 Al, published Feb. 7, 2002.
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Appeal2013-008995
Application 11/995,693
188Re-labeled mAbs were found to be a marginal agent for
controlling tumor growth. The failure of 188Re-IgG in some
tumor models may be related to the combination of apparent
instability of the labeled product and its short physical half-life.
Interestingly the dissociation of 188Re from the protein occurred
more quickly that for other isotopes such as 88Y. The release of
rhenium is likely to be assisted by reoxydation of the chelate to
ReQ4- by dissolved oxygen.
(Kotov i-f 15; see Ans. 6.)
FF 5. Kotov discloses that:
In connection with the present invention, instead of a
multidentate ligand with a radioactive ion in the middle a
radioactive nanoparticle is covalently linked to a biological
vector molecule such as mAb, its fragment, peptide, or others.
NPs [(nanoparticles)] are synthesized separately from a suitable
isotope and then conjugated to biological molecules by using
procedures similar to those for chelates. For example, terminal
groups of stabilizer molecules coating NPs can be chemically
modified to p-isothiocyanotobenzyl derivatives, which can be
coupled to NH2 groups of lysine residues of proteins.
Alternatively, NP-protein conjugates can be prepared via NP-
biotin dyads (NP-B) to provide a synthetic route to preparation
of heterogeneous conjugates combining two different bioactive
moi[ e ]ty. The new radiopharmaceuticals substantially improve
the clinical properties of currently used radiolabeled
compounds.
(Kotov i128; see id. i122 (the acronym "NPs" means "[n]anoparticles"); Ans.
6.)
FF 6. Kotov discloses:
[I]nvention metal chelates [that] are replaced with small (2-5
nm in diameter) clusters of metal sulfide nanoparticles bound to
mAbs or other biological molecules via a bifunctional organic
stabi 1 izer. The core materials of the nanoparticles, i.e.
transition metal sulfides, are virtually insoluble in aqueous
solutions due to partially covalent character of the crystal
lattice. Negligible concentration of ionic species prevents
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Appeal2013-008995
Application 11/995,693
transchelation in serum and release of radioisotopes in
circulation.
(Kotov i-f 21; see also id. Abstract (Kotov discloses "[a] bioconjugate
including a nanoparticle covalently linked to a biological vector molecule.
The nanoparticle is a generally radioactive metal ion" and "[t]he biological
vector molecule is typically a monoclonal antibody or fragment of a
monoclonal antibody or a peptide having a known affinity to cancer cells,"
wherein "[ o ]ne or more additional, different biological moieties may be
covalently linked to the nanoparticle in addition to the biological vector
molecule to enhance its activity."); Ans. 6).
FF 7. Based on paragraphs 15 (FF 4) and 28 (FF 5) ofKotov, Examiner
"assume[s] that the radioistopes are non-covalently bonded to the
nanoparticle" suggested by the combination of Salafsky and Hainfeld (Ans.
6; see id. ("Kotov discloses radioconjugates including nanoparticles of an
AgS-metallic core and a thiol-containing lipophilic coating, acting as a
ligand, and the biological vector molecule is bonded to the reactive group of
the ligand (abstract and 0021 )").
ANALYSIS
Based on the combination of Salafsky, Hainfeld, and Kotov, Examiner
concludes that, at the time Appellants' invention was made, it would have
been prima facie obvious "to incorporate [the disclosure of Hainfeld and
Kotov] into Salaf[s]ky's composition" (Ans. 6). While the foregoing may be
true, Appellants contend, inter alia, that Examiner failed to establish a
factual basis on this record to support a conclusion that the combination of
Hainfeld, Kotov, and Salafsky suggests a nanoparticle, within the scope of
Appellants' claimed invention, wherein "the radioisotope is both non-
covalently bound and outside the metal core" (Br. 8; see id. at 7).
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Appeal2013-008995
Application 11/995,693
We recognize Examiner's assertion that Hainfeld "discloses that the
material of the surface layer or metallic core [] includes a radioactive
isotope" (Ans. 9; see FF 2). Examiner, however, failed to establish an
evidentiary basis on this record to support a conclusion that Hainfeld
discloses at least one radioisotope non-covalently bonded to the
nanoparticle, such that the radioisotope is outside the metallic core of the
nanoparticle, as is required by Appellants' claimed invention (see
Appellants' independent claims 1 and 16). Thus, Examiner failed to rebut
Appellants' contention that "Hainfeld does not describe how the
radioisotope is attached" (Br. 6).
We recognize Examiner's assumption that Kotov' s "radioisotopes are
non-covalently bonded to the nanoparticle" (Ans. 6; FF 7). Examiner,
however, failed to explain how such an assumption was drawn from
Examiner's reliance on Kotov (see Ans. 6; cf FF 4--7). "[R]ejections on
obviousness grounds cannot be sustained by mere conclusory statements;
instead, there must be some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness." In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006).
For the foregoing reasons, we are compelled to agree with Appellants'
conclusion that "the combination of Salafsky in view of Hainfeld and Kotov
does not [make] obvious the subject matter of [Appellants'] claimed
invention" (Br. 8).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness. The rejection of claims 1-17 under
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Appeal2013-008995
Application 11/995,693
35 U.S.C. § 103(a) as unpatentable over the combination of Salafsky,
Hainfeld, and Kotov is reversed.
REVERSED
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