Ex Parte Krichevsky

Patent Trial and Appeal Board

May 3, 2016

12670340 (P.T.A.B. May. 3, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/670,340 01122/2010
13963 7590 05/05/2016
GLOBAL PATENT GROUP - BGL
1005 North Warson Road
Suite 404
Saint Louis, MO 63132
FIRST NAMED INVENTOR
Alexander Krichevsky
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.
BGLOOOl-501-US 1663
EXAMINER
KUBELIK, ANNE R
ART UNIT PAPER NUMBER
1662
NOTIFICATION DATE DELIVERY MODE
05/05/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ALEXANDER KRICHEVSKY
Appeal2013-010673
Application 12/670,340
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
r-T"I .. • • .. 1 .. ,..... ,_ TT r'1 I'\ l\ -1,..... Al • "1 • "1 • , ims 1s an appear unaer j) u.~.L. s U4 mvo1vmg crnm1s to a
transgenic biolmninescent plant. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
1 Appellant identifies the Real Party in Interest as BioGlow LLC.
(see App. Br. 3).
Appeal2013-010673
Application 12/670,340
Statement of the Case
Background
"Non-bacterial organisms such as plants that are capable of
bioluminescence would be useful for ... environmental and aesthetic
applications. However, such organisms have not been readily achieved for
many reasons. For example, the genes and mechanisms responsible for
bioluminescence are complex" (Spec. 1, 11. 16-18).
The Claims
Claims 1, 4, 10, 13, 17, and 41--46 are on appeal. 2 Independent claim
1 is representative and reads as follows:
1. A transgenic bioluminescent plant comprising:
an expressible heterologous nucleotide sequence
comprising a bacterial LUX operon, which comprises LUX
A, LUX B, LUX C, LUX D, LUXE, and LUX G genes,
wherein the heterologous nucleotide sequence is
expressed to render the plant bioluminescent; and
wherein the heterologous nucleotide sequence is
integrated in a plastid genome.
The Issue
A. The Examiner rejected claims 1, 4, 10, 13, 17, 41, and 42 under
35 U.S.C. § 103(a) over Hudkins,3 Maliga,4 and Swartzman5 (Ans. 2--4).
2 Claims 11 and 12 are withdrawn and claims 2, 3, 5-9, 14--16, and
18--40 were cancelled (see Resp. Election/Restriction 2/21/2012).
3 Hudkins, US 7,663,022 Bl, issued Feb. 16, 2010.
4 Maliga et al., US 5,877,402, issued Mar. 2, 1999.
5 Swartzman et al., Delineation of the Transcriptional Boundaries
of the lux Operon of Vibrio harveyi Demonstrates the Presence of
Two New lux Genes, 6 J. Biol. Chem. 3513-3517 (1990).
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Application 12/670,340
B. The Examiner rejected claims 43--46 under 35 U.S.C. § 103(a) over
Hudkins, Maliga, Swartzman, and McBride6 (Ans. 4--5).
The issue with respect to these rejections is: Does the evidence of
record support the Examiner's conclusion that Hudkins, Maliga, Swartzman
and/or McBride provide a reasonable expectation of success?
A. 35 U.S.C. § 103(a) over Hudkins, Maliga, and Swartzman
Findings of fact
1. Hudkins teaches
[a] method for making a transgenic bioluminescent plant,
comprising the steps of:
selecting from a foreign genome at least one lux gene
encoding a luciferase and at least one lux gene encoding a
luciferin that is compatible with said luciferase, wherein
said foreign genome contains a lux operon;
constructing at least one vector using a first plasmid, a
second plasmid and a third plasmid, wherein said at least
one vector comprises at least one light inducible promoter
for regulation of expression of said lux genes, wherein said
first plasmid comprises luxA and luxB, said second
plasmid comprises luxC and luxD, and said third plasmid
comprises luxE and frp, wherein said frp encodes a flavin
reductase;
transfecting at least one plant cell with said at least one
vector, wherein said at least one plant cell is selected from
the group consisting of a monocotyledon cell and a
dicotyledon cell; and
growing said at least one plant cell into a mature plant
(Hudkins, Claim 1 ).
6 McBride et al., US 5,576,198, issued Nov. 19, 1996.
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Application 12/670,340
2. Hudkins teaches "[t]he method of claim 1 wherein said at least
one vector further comprises a targeting sequence such that expressed
polypeptides are directed to a specific organelle" (Hudkins, Claim 11 ).
3. Hudkins teaches that:
It is possible that in some or all plants, bioluminescence will
be enhanced by directing the luciferase and corresponding
luciferin to a specific location within the plant. This may be
accomplished using control sequences that result in the
addition of amino acids at either the N- or C-termini of the
proteins .... For example, some control sequences direct
proteins to the chloroplasts.
(Hudkins, col. 7, 11. 57-66).
4. Maliga teaches
DNA constructs ... for stable transformation of plastids of
multicellular plants and expression of foreign proteins in
plastids. The DNA constructs comprise a transforming
DNA which is targeted to a pre-determined location on the
plastid genome and inserted into the plastid genome by
homologous recombination with targeting segments
comprising DNA sequences homologous to the pre-
determined region of the plastid genome.
(Maliga, Abstract).
5. Example 6 of Maliga teaches "an E. coli p UC 119 plasmid
derivative, pPRVl ... The pPRV series are designed specifically for
efficient gene delivery to plastids of higher plants, or for any organelle
genome" (Maliga, col. 51, 1. 58 to col. 52, 1. 8).
6. Maliga teaches "polycistronic read-through transcript[]
initiation from the upstream rbcL promoter" including the expression of
three genes (Maliga, col. 63, 11. 62---64).
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Application 12/670,340
7. Figure 5 of Swartzman teaches the "[ n ]ucleotide and
accompanying amino acid sequence of the luxG ... genes of V. harveyi"
(Swartzman 3516, col. 1).
8. Zhou7 discloses that
it is generally not possible to make educated guesses about
the translatability of polycistronic transcripts in plastids.
This is highly unfortunate, because simultaneous expression
of multiple transgenes from operons is viewed as one of the
unique attractions of chloroplast transformation technology .
. . . Expression of transgenes from polycistronic mRNAs has
been successful in some cases ... but poor translation of
polycistronic mRNAs is likely to be responsible for at least
some cases where transgene expression was disappointingly
low ... or unsuccessful altogether .... Clearly, processing
of polycistronic transcripts into stable monocistronic
mRNAs would greatly reduce the risk of failure of trans gene
expression from the plastid genome and thus make
transplastomic experiments more predictable
(Zhou 962, col. 2).
Principles of Law
The admonition that "obvious to try" is not the standard
under § 103 has been directed mainly at two kinds of error
.... In some cases, what would have been "obvious to try"
would have been to vary all parameters .... In others, what
was "obvious to try" was to explore a new technology or
general approach that seemed to be a promising field of
experimentation, where the prior art gave only general
7 Zhou et al, Identification of a plastid intercistronic expression
element (IEE) facilitating the expression of stable translatable
monocistronic mRNAsfrom operons, 52 Plant J. 961-972 (2007).
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Application 12/670,340
guidance as to the particular form of the claimed invention
or how to achieve it.
In re O'Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988).
Analysis
Appellant contends that the Examiner's position that
"Hudkins et al teaches expression of the lux operon in
plants" ... is a mischaracterization of Hudkins et al.: this
reference prophetically teaches plants whose nuclear
genome has been transformed with a bacterial L UXA/L UXB
fusion protein gene, individual LUXC, LUXD, and LUXE
genes, and a flavin-reductase-encodingfrp gene, targeted to
chloroplasts, not transformation and expression of these
genes in the form of an operon into plastids as in the
presently claimed invention.
(App. Br. 16-17). Appellant contends that "[i]f successful expression of the
bacterial LUX genes is not readily achievable in other bacteria as disclosed
in Francis et al., ho\'l/ can expression of these genes be considered
predictable in plastids of plants, which are more distant from gram negative
bacteria than the gram positive bacteria employed in Francis et al.?" (App.
Br. 17).
The Examiner responds that "Hudkins teaches plants whose nuclear
genome was transformed with the genes encoding the LUX proteins targeted
to chloroplasts. Use of 'operon' in this context in the response to arguments
portion of the final rejection was an imprecise shortcut" (Ans. 16). The
Examiner finds that "successful expression of the LUX genes was readily
achievable in other bacteria, as Francis showed" (Ans. 16).
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We find that Appellant has the better position. As we balance the
evidence, we are persuaded by Zhou and the Beachy Declaration8 that there
would not have been a reasonable expectation of successfully expressing a
complete bacterial LUX operon, as required by claim 1, or functionally
integrating the complete LUX operon as required by claim 42, in plant
plastids. While Maliga teaches a single example where tricistronic
expression was obtained in plant plastids (FF 5---6), Zhou evidences that
prior to the discovery of intercistronic expression elements, expression of
polycistronic transcripts in plastids was unpredictable (FF 8).
Our opinion in this regard is further buttressed by the Beachy
Declaration that teaches
the processing of operon-encoded polycistrons in plastids is
not currently well understood. . . . Drechsel ... notes that
while in bacteria all genes on polycistronic mRNA are
translated with the same efficiency, in plastids only the first
ORF of the same operon may be effectively translated, \vi th
downstream open reading frames either being translated
with much lower efficiency, or not at all.
(Beachy Deel. 5). The Beach Deel. further notes that "[ c ]oordinated
expression of proteins from the LUX operon is essential to the production of
light from the LUX operon. . . . In the absence of the proper number of
molecules of each protein, luminescence will not occur" (Beachy Deel. 6).
The Beachy Deel. further notes that "I am aware of at least one company
(Chlorogen Inc.) that failed because it was unable to successfully express
single proteins in chloroplasts that would confer value to the host crop"
(Beachy Deel. 7). The Beachy Deel. concludes that the "utility and success
8 Declaration of Dr. Roger N. Beachy, dated June 22, 2012.
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of the invention described in [the] claims ... are surprising in view of ...
the many different levels at which problems in activating bioluminescence
could arise" (Beachy Deel. 7).
Here, the rejection fell into the second error identified by 0 'Farrell,
"where the prior art gave only general guidance" without providing the tools
necessary to achieve successful expression of the entire bacterial LUX
operon in plastids in the manner necessary to achieve bioluminescence.
O'Farrell, 853 F.2d at 903.
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that Hudkins, Maliga, and Swartzman provide a reasonable expectation of
success so as to support a legal conclusion of obviousness.
B. 35U.S.C.§103(a) over Hudkins, Maliga, Swartzman, and McBride
McBride teaches an operon for expression of two or more structural
genes in a plant cells, but does not relate to the LUX genes and their
expression (McBride, Claim 15). Having concluded that the evidence of
record does not support the Examiner's conclusion that Hudkins, Maliga,
and Swartzman provide a reasonable expectation of success so as to support
a legal conclusion of obviousness of claims 1, 4, 10, 13, 17, 41, and 42, we
also reverse the rejection of dependent claims 43--46.
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Application 12/670,340
SUMMARY
We reverse the rejection of claims 1, 4, 10, 13, 17, 41, and 42 as
obvious over Hudkins, Maliga, and Swartzman.
We reverse the rejection of claims 43--46 as obvious over Hudkins,
Maliga, Swartzman, and McBride.
REVERSED
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