Ex Parte Woods et al

Patent Trial and Appeal Board

Nov 21, 2016

12368060 (P.T.A.B. Nov. 21, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/368,060
77607 7590
Algenol Biotech LLC
Attn: IP/Legal Dept.
16121 Lee Road
Suite 110
Fort Myers, FL 33912
0210912009
11/23/2016
FIRST NAMED INVENTOR
R. Paul Woods
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.
P0004.02.US 1195
EXAMINER
RAMIREZ, DELIA M
ART UNIT PAPER NUMBER
1652
NOTIFICATION DATE DELIVERY MODE
11/23/2016 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):
david.lorenz@algenol.com
suzanne.jepson@algenol.com
ip.legal@algenol.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte R. PAUL WOODS, CRAIG R. SMITH, DAN KRAMER,
HEIKE ENKE, KERSTIN BAIER, ULF DUHRING, KARL ZIEGLER,
WOLFGANG LOCKAU, MARIANNE GRUNDEL, JOHN COLEMAN,
and CHRISTINE OESTERHELT
Appeal2014-000811
Application 12/368,060 1
Technology Center 1600
Before ERIC B. GRIMES, JACQUELINE T. HARLOW, and
KRISTI L. R. SA WERT, Administrative Patent Judges.
SA WERT, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the rejection of claims
1-3, 6, 8, 9, and 14--17. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm-in-part and reverse-in-part.
1 Appellants identify Algenol Biofuels Incorporated as the real party
in interest. Appeal Br. 3.
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STATEMENT OF THE CASE
Claims 1-3, 6, 8, 9, and 14--17 are on appeal and stand rejected2 as
follows:
A. Claims 1-3, 6, 8, 9, and 14--17 under 35 U.S.C. § 112, second
paragraph, for indefiniteness;
B. Claims 1-3, 6, 8, 9, 14, and 15 under 35 U.S.C. § 112, first
paragraph, for lack of written description;
C. Claims 1-3, 6, 8, 9, 14, and 15 under 35 U.S.C. § 112, first
paragraph, for lack of enablement;
D. Claims 1-3, 6, 8, 9, 14, and 15 under 35 U.S.C. § 103(a) for
obviousness over Deng3 in view of Wahlund, 4 Spreitzer, 5 and
Amichay; 6 and
E. Claims 1-3, 6, 8, 9, and 14--17 under 35 U.S.C. § 103(a) for
obviousness over Deng in view of Wahlund, Spreitzer, and
Amichay, Duhring, 7 and further in view of Kaneko. 8
Final Off. Act. 3-17.
2 The Examiner also objected to claims 6, 8, and 14. See Final Off.
Act. 3, 1 7. Appellants state that they amended claims 6 and 14 when filing
the Appeal Brief "pending entry into the record," Appeal Br. 5, but the
Examiner states that the rejections on appeal are applied to the claims "as
submitted in a communication filed on 8/7/2012," Ans. 2. Thus, we
understand that the Examiner did not enter the amendments made at the time
the Appeal Brief was filed.
3 Applied and Environmental Microbiology, 65(2):523-528 (1999).
4 Am. Chem. Soc. Div. Fuel Chem., 41: 1403-1406 (1996).
5 Annu. Rev. Plant Biol., 53:449-475 (2002).
6 Plant Molecular Biology, 23:465--476 (1993).
7 PNAS, 103(18):7054--7058 (2006).
8 GenBank Accession No. BA000022 (May 20, 2006).
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Independent claim 1 is illustrative of the claimed subject matter on
appeal. Claim 1 provides:
1. A genetically modified cyanobacteria host cell which produces
ethanol (C2HsOH) and oxygen (02) comprising:
a. a first genetic modification which changes the enzymatic
activity or affinity of an endogenous host cell enzyme, wherein
the first genetic modification is an overexpressed ribulose-1,5-
bisphosphate carboxylase/oxygenase (RubisCO); and
b. a second genetic modification which introduces an
overexpressed pyruvate decarboxylase enzyme associated with
the formation of ethanol.
Appeal Br. 32.
DISCUSSION
A. Indefiniteness
The Examiner rejected claims 1-3, 6, 8, 9, and 14--17 under 35 U.S.C.
§ 112, i-f 2, for failing to particularly point out and distinctly claim the
subject matter applicant regards as the invention. "[A] claim is indefinite
when the boundaries of the protected subject matter are not clearly
delineated and the scope is unclear." Supplementary Examination
Guidelines for Determining Compliance With 35 US.C. § 112 andfor
Treatment of Related Issues in Patent Applications, 76 Fed. Reg. 7164 (Feb.
9, 2011) ("Indefiniteness Guidelines"); see also MPEP § 2173.02; In re
Packard, 751F.3d1307, 1310 (Fed. Cir. 2014) ("[W]e affirm the Board's
findings as to indefiniteness under the MPEP standard properly applied by
the USPTO .... "). The Examiner sets forth several rationales for rejecting
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the claims for indefiniteness. Because we agree with some, but not all, of
those rationales, we reverse the rejection as to claims 1-3, 6, and 15-17, but
affirm the rejection as to claims 8, 9, and 14. We address each rejected
claim in the order presented by the Examiner below.
Claims 1-3, 6, 8, 9, and 14-17
The Examiner states that the claims 1-3, 6, 8, 9, and 14--17 are
indefinite for reciting "overexpressed ribulose ... oxygenase,"
"overexpressed pyruvate decarboxylase," and "overexpressing a complete
operon." Final Off. Act. 3. The Examiner asserts that "[t]he terms
'overexpressed' and 'overexpressing' are indefinite in the absence of a basis
for comparison." Id. We disagree. Claim definiteness "requires a
determination of whether those skilled in the art would understand what is
claimed when the claim is read in light of the specification." MPEP
§ 2173.02 (emphasis added). Here, we find that an ordinarily skilled artisan
would readily understand that "overexpressed" and "overexpressing" refer to
increased expression of the protein of interest over the wild type (i.e., non-
genetically modified cyanobacteria) host cell. See, e.g., Spec. 70 (i-f 473).
The prior art cited by the Examiner also supports our finding that
"overexpression" is a well-known term to those skilled in the art. For
example, Duhring also describes overexpression in comparison to a wild
type. Duhring 7055 (Fig. 2). Thus, we reverse this rejection.
Claims 8 and 9
The Examiner states that claim 8 and dependent claim 9 are indefinite
for reciting "level of a first metabolic intermediate in the genetically
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modified host cell compared to the level of the first metabolic intermediate
in a host cell lacking the first genetic modification." Final Off. Act. 3. The
Examiner explains that, because the phrase "does not require the comparison
to be made with the corresponding cyanobacterial host cell lacking the first
modification but rather allows for the comparison to be made with any host
cell lacking the first modification," the claim is unclear as to whether the
comparison host cell encompasses any host cell or only a cyanobacteria host
cell. Id. at 3--4 (emphasis added). We agree.
Section 112 requires claims "to be cast in clear-as opposed to
ambiguous, vague, indefinite-terms." Packard, 751 F.3d at 1313. The
USPTO must "test the claims for reasonable precision" in the context of the
specification and the relevant subject matter to "ensur[ e] that patent claims
are clear and unambiguous." Id. Indeed, "the patent drafter is in the best
position to resolve the ambiguity in the patent claims, and it is highly
desirable that patent examiners demand that applicants do so in appropriate
circumstances so that the patent can be amended during prosecution rather
than attempting to resolve the ambiguity in litigation." Halliburton Energy
Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255 (Fed. Cir. 2008). To this end,
the Federal Circuit has explained:
when the USPTO has initially issued a well-grounded rejection
that identifies ways in which language in a claim is ambiguous,
vague, incoherent, opaque, or otherwise unclear in describing
and defining the claimed invention, and thereafter the applicant
fails to provide a satisfactory response, the USPTO can properly
reject the claim as failing to meet the statutory requirements of
§ 112(b).
Packard, 751 F.3d at 1311.
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Here, Appellants' response to the Examiner's rejection has only added
to the ambiguity of the claims. Appellants assert that the Specification
"provides a basis for comparison to a corresponding cyanobacteria host cell
lacking the first genetic modification." Reply Br. 6 (emphasis added). But,
Appellants then recite a passage from the Specification that refers merely to
a "photoautotrophic ethanol producing host cell." Id. (citing Spec. 43: 19--
26). We note, however, that cyanobacteria are not the only
photoautotrophic, ethanol-producing cells disclosed in the Specification.
For example, as the Examiner explained, the comparison host cell could be
B. subtilis. Ans. 18. Because the scope of the claims remains unclear, we
affirm this rejection.
Claim 14
The Examiner rejected claim 14 for indefiniteness. Claim 14 depends
from claim 1. As noted above, claim 1 requires the "first genetic
modification" to be "an overexpressed ribulose-1,5-bisphosphate
carboxylase/oxygenase (RubisCO)," and the "second genetic modification"
to "introduce[] an overexpressed pyruvate decarboxylase enzyme associated
with the formation of ethanol." Claim 14 further limits the "first genetic
modification" to "the group consisting of (a) integrating a conjugative, self-
replicating p VZ plasmid containing a rbcLXS operon present as
transcriptional fusion with a pyruvate decarboxylase from Zymomonas
mobilis, into the genetically modified Synechocystis
host cell, (b) overexpressing only small subunits and large subunits of
ribulose-1,5-bisphosphate carboxylase/oxygenase (RubisCO), ( c)
overexpressing a complete operon including a Chaperonin for ribulose-1,5-
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bisphosphate carboxylase/oxygenase (RubisCO), and ( d) random or site
directed mutagenesis of ribulose-1,5-bisphosphate carboxylase/oxygenase
(RubisCO)." Appeal Br. 35.
The Examiner finds member (a) of the Markush group, i.e.,
"integrating ... plasmid containing a rbcLXS operon present as a
transcriptional fusion with a pyruvate decarboxylase from Zymomonas,"
confusing because both the "first genetic modification" and the "second
genetic modification" require the expression of pyruvate decarboxylase.
"Therefore," the Examiner explains, "it is unclear how ... the first
modification [can] comprise the second modification, or whether the
expression of two pyruvate decarboxylases is required." Final Off. Act. 4.
We agree with the Examiner that the claim is unclear under Packard.
We acknowledge Appellants' argument that the claim merely refers to
a specific embodiment of the invention described in the Specification, i.e.,
the integration of a conjugative, self-replicating p VZ plasmid into
Synechocystis containing either the rbcLXS operon alone or the rbcLXS
operon as transcriptional fusion together with the pyruvate decarboxylase
from Zymomonas. See Spec. 109. We further acknowledge Appellants'
arguments that the claim intends to refer to a plasmid containing both the
first genetic modification and the second genetic modification, as described
in the Specification. Appeal Br. 13-14. The problem with claim 14,
however, is that it purports to limit the "first genetic modification," not the
"second genetic modification." Again, claims must issue from the USPTO
in "clear and unambiguous" form. Packard, 751 F.3d at 1313. And because
claim 14 is not clear, we must affirm this rejection.
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The Examiner next states that element (c) of the Markush group, i.e.,
overexpressing a complete operon including a Chaperonin for ribulose-1,5-
bisphosphate carboxylase/oxygenase (RubisCO)," is indefinite because
"unclear as to which complete operon is being overexpressed." Final Off.
Act. 4. As to this rejection, we agree with Appellants that the Specification
provides a definition of "complete operon" for RubisCO overexpression.
See Appeal Br. 14. Specifically, the Specification describes the "complete
operon" as an operon that comprises genes encoding a RubisCO large
subunit, a RubisCO small subunit, and a RubisCO chaperonin. Thus, we
reverse this basis for rejection.
The Examiner finds that "into the genetically modified Synechocystis
host cell," recited in member (a) of the Markush group, lacks proper
antecedent basis. Final Off. Act. 4 (emphasis added). We agree. A claim
term lacks antecedent basis when the claim "contains no earlier recitation or
limitation" of that term. MPEP § 2173.05(e). Here, neither claim 1 nor
claim 14 first limit the cyanobacteria of claim 1 to "a" genetically-modified
Synechocystis host cell. And because cyanobacteria are not necessarily
Synechocystis, we agree with the Examiner that claim 14 is unclear. Thus,
we affirm this basis for rejection.
Finally, the Examiner asserts that it is unclear how "random or site-
directed mutagenesis of ribulose ... oxygenase," recited in member (d) of
the Markush group, properly depends from claim 1. Final Off. Act. 5. The
"first genetic modification" in claim 1, from which claim 14 depends, results
in "an overexpressed ribulose-1,5-bisphosphate carboxylase/oxygenase
(RubisCO)." The Examiner states that an ordinarily skilled artisan would
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understand that "first genetic modification" to require the transformation of
an exogenous RubisCO, but the same "first genetic modification" in claim
14 requires modification of an endogenous RubisCO. Final Off. Act. 5. We
disagree with the Examiner that "first genetic modification" of claim 1
requires the transformation of an exogenous RubisCO. Indeed, as discussed
below, the broadest reasonable interpretation of claim 1 encompasses any
modification that results in the overexpression of RubisCO. Section (d) of
claim 14 limits the "first genetic modification" to random or site directed
mutagenesis of RubisCO. Put differently, random or site directed
mutagenesis of RubisCO is one modification that may result in
overexpression of RubisCO. Although we acknowledge that the claim is
very broad, mere breadth is not indefiniteness. In re Gardner, 427 F.2d 786,
788 (CCPA 1970). Thus, we reverse this basis for rejection.
Claim 16
The Examiner rejects claim 16 for reciting "95% identity to
Synechocystis . .. (SEQ ID NO: 65)." Final Off. Act. 5. Claim 16 recites
that "the nucleic acid encoding said ribulose-1,5-bisphosphate
carboxylase/oxygenase (RubisCO) has at least 95% identity to
Synechocystis rbcL-rbcX-rbcS (SEQ ID NO: 65)." Appeal Br. 35. The
Examiner asserts that "Synechocystis rbcL-rbcX-rbcS" by itself is unclear,
and that "it is unclear if the sequence in parenthesis is the reference sequence
which needs to be used to determine the 'at least 95% identity' recited."
Final Off. Act. 5. We agree with Appellants that this claim is sufficiently
clear to an ordinarily skilled artisan in view of the Specification. See Appeal
Br. 15. First, the Sequence Listing lists SEQ ID NO: 65 as the DNA
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sequence of the three genes rbcL-rbcX-rbcS from Synechocystis in order.
Second, because SEQ ID NO: 65 is the DNA sequence of rbcL-rbcX-rbcS,
one of one skilled in the art would understand that the claimed nucleic acid
has at least 95% identity to the sequence disclosed as SEQ ID NO: 65.
Thus, we reverse this rejection.
Claim 17
Finally, the Examiner states that claim 17 is indefinite for reciting "the
rbcL gene," "the rbcS gene encodes," and "the rbcX gene encodes," without
proper antecedent basis. Final Off. Act. 5---6. Claim 17 recites that "the
rbcL gene encodes rubisco large subunit protein having at least 95% identity
to SEQ ID NO: 66; the rbcS gene encodes a rubisco small subunit protein
having at least 95% identity to SEQ ID NO: 68, and the rbcX gene encodes a
rubisco chaperonin having at least 95% identity to SEQ ID NO: 67 ." Appeal
Br. 35. We disagree, as rbcL, rbcS, and rbcX have antecedent basis in claim
16, from which claim 17 depends. Thus, we reverse this rejection.
B. Written Description
The Examiner rejected claims 1-3, 6, 8, 9, 14, and 15 under 35 U.S.C.
§ 112, i-f 1, for lack of written description. Final Off. Act. 6-7. The first
paragraph of§ 112 requires that the specification contain a written
description of the claimed invention. 35 U.S.C. § 112, i-f 1 (2011). "[T]he
hallmark of written description is disclosure." Ariad Pharms., Inc. v. Eli
Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en bane). The written
description requirement is met when the specification "conveys to those
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skilled in the art that the inventor had possession of' and "actually invented"
the claimed subject matter. Id.
For claims encompassing a genus, sufficient written description
"requires the disclosure of either a representative number of species falling
within the scope of the genus or structural features common to the members
of the genus so that one of skill in the art can 'visualize or recognize' the
members of the genus." Id. at 1350 (quoting Regents of the Univ. of
California v. Eli Lilly & Co., 119 F.3d 1559, 1568---69 (Fed. Cir. 1997)).
Functional claim language may meet the written description requirement
when there is a "known or disclosed correlation between function and
structure." Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed.
Cir. 2002) (quotation omitted). But in the absence of a structure-function
correlation, the written description requirement demands "a precise
definition, such as by structure, formula, chemical name, physical properties,
or other properties, of species falling within the genus sufficient to
distinguish the genus from other materials." Ariad, 598 F.3d at 1350.
We find that a preponderance of the evidence supports the Examiner's
finding of a lack of written description. The claimed invention encompasses
a genetically-modified cyanobacterial host cell that overexpresses RubisCO
enzyme. See Appeal Br. 32 (claim 1 ). Thus, as the Examiner explained and
we agree, the claims encompasses any modification that results in
overexpression of RubisCO. Final Off. Act. 6-7. But, as the Examiner also
found and we agree, the Specification only provides written description
support for two such modifications: increasing the copy number of a nucleic
acid encoding a RubisCO enzyme, and placing a nucleic acid encoding a
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RubisCO enzyme under the control of a strong heterologous promoter. Id. at
7. We find that the disclosure of only two modifications to support a claim
to any and all modifications does not amount to "a representative number of
species falling within the scope of the genus." Ariad, 598 F.3d at 1350.
We are not persuaded otherwise by Appellants' argument that "[ t ]here
is no requirement in patent law that the application provide written
description for 'any' modification to achieve the claimed embodiment."
Appeal Br. 1 7. Although we agree that the Specification need not describe
each and every possible modification, the Federal Circuit nonetheless
dictates that "an adequate written description of a claimed genus requires
more than a generic statement of an invention's boundaries." Ariad, 598
F.3d at 1349.9 Here, Appellants have generically provided the outer
boundaries of the claimed "first genetic modification" through the use of
functional language (i.e., any modification that results in overexpression of
9 We must follow the Federal Circuit's en bane decision in Ariad, and
note that, to the extent that earlier cases may conflict (i.e., In re Vaeck, 947
F.2d 488, 496 (Fed. Cir. 1991) andin re Angstadt, 537 F.2d 498 (CCPA
197 6) ), those cases do not control the written description analysis here. We
also note that Vaeck and Angstadt are inapposite because those cases address
enablement, not written description. We also find Appellants' reliance on
Tilghman v. Proctor, 102 U.S. 707, 728 (1880), Reply Br. 10, similarly
deficient. Tilghman does not stand for the broad proposition that the
Specification need only describe one species in every case. Indeed, the
Federal Circuit has explained that determining compliance with the written
description requirement is a fact-intensive inquiry, that "depend[s] on the
nature and scope of the claims and on the complexity and predictability of
the relevant technology." Ariad, 598 F.3d at 1351. Here, there can be no
serious dispute that the broad claims are directed to a highly complex and
unpredictable technology.
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RubisCO), but have failed to show in the Specification that they actually
possessed a representative number of those modifications. Indeed, as the
Examiner explained and Appellants do not appear to dispute, the claimed
invention encompasses "modifications such as the addition of any type of
compound/chemical that would enhance expression, modifications to the
regulatory region of any cyanobacterial RubisCO gene to increase
expression, and expression of unknown proteins which would act as inducers
of RubisCO expression," none of which are disclosed in the Specification.
Final Off. Act. 7. We find that "[ c ]laiming all [modifications] that achieve a
result without defining what means will do so is not in compliance with the
description requirement; it is an attempt to preempt the future before it has
arrived." Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993).
In sum, Appellants have not disclosed a representative number of
"first genetic modifications," and the Specification provides insufficient
relevant identifying characteristics of the modifications to show that
Appellants "had possession of' and "actually invented" the claimed subject
matter. Ariad, 598 F.3d at 1351. Thus, we agree with the Examiner that the
claims lack adequate written description.
C. Enablement
The Examiner also rejected claims 1-3, 6, 8, 9, 14, and 15 under 35
U.S.C. § 112, i-f 1, for lack of enablement. Final Off. Act. 10-13. The first
paragraph of§ 112 requires that the specification enable a person of ordinary
skill in the art "to make and use the invention." 35 U.S.C. § 112, i-f 1 (2011).
The enablement requirement is met when the skilled artisan, having read the
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specification, could practice the claimed invention without "undue
experimentation." In re Wands, 858 F.2d 731, 736-37 (Fed. Cir. 1988).
"Whether undue experimentation is needed is not a single, simple factual
determination, but rather is a conclusion reached by weighing many factual
considerations," including:
(1) the quantity of experimentation necessary, (2) the amount of
direction or guidance presented, (3) the presence or absence of
working examples, (4) the nature of the invention, (5) the state
of the prior art, ( 6) the relative skill of those in the art, (7) the
predictability or unpredictability of the art, and (8) the breadth
of the claims.
Id. at 737 ("the Wands factors").
The Examiner considered all the Wands factors, and discussed the
implications of several with respect to the claimed invention. Ans. 7-10.
We find that a preponderance of the evidence supports the Examiner's
analysis of the Wands factors and adopt them as our own. We also agree
with the Examiner's ultimate determination that, although the Specification
reasonably enables "a genetically engineered cyanobacterial cell transformed
with a nucleic acid encoding a RubisCO, an alcohol dehydrogenase and a
pyruvate decarboxylase," the Specification "does not reasonably provide
enablement for a genetically modified cyanobacterial cell modified in any
way to increase the expression of an endogenous RubisCO." Final Off. Act.
7.
On appeal, Appellants rely the Federal Circuit's decision in Invitrogen
v. Clontech, 429 F.3d 1052 (Fed. Cir. 2005) to argue that practicing the
claimed invention would not require undue experimentation. See Appeal Br.
19-20. Specifically, Appellants argue that because the Specification enables
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one "mode of making and using the invention," the legal requirement of
enablement is met. Appeal Br. 19 (quotinginvitrogen, 429 F.3d at 1071).
Appellants point to the Specification as providing "[a Jn example of
enablement ... that discloses ethanologenic cyanobacterial cells that
overexpress RubisCO that exhibited increased RubisCO activity." Appeal
Br. 20.
The claims in Invitrogen were directed to a genetically engineered
polypeptide ("reverse transcriptase" or "RT"), "without regard for the
method used to mutate the genes" to create the polypeptide. 429 F.3d at
1070. It was undisputed that, at the time the application leading to the
patent-in-suit was filed, skilled artisans "knew several techniques for
altering genetic sequences, including deletion and point mutations." Id. The
patent-in-suit described how to obtain a genetically engineered RT by
deletion mutation, but not point mutation. Id. The Federal Circuit agreed
with the district court that the full scope of the claims was sufficiently
enabled. Id. at 1071. In particular, the court noted that the enablement
requirement was met for the compound claim because the combination of
the "mode of making" disclosed in the specification and genetic-
modification techniques already known in the art reasonably allowed for the
skilled artisan to make and use the genetically modified RT without undue
experimentation. Id.
This case is different. Here, the claims are drawn to a genetically
modified cell that overexpresses RubisCO and pyruvate decarboxylase. See
Claim 1, supra. In the case of a genetically modified polypeptide, skilled
artisans know several techniques for genetically modifying the underlying
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genetic sequence. But, in the case of a genetically modified cell, many
factors may lead to overexpression of a particular enzyme, including
currently unknown upstream factors that influence the expression of
RubisCO and pyruvate decarboxylase. See Ans. 23-25. Thus, we determine
that the disclosure of one method for causing overexpression of RubisCO
and pyruvate decarboxylase does not adequately enable claims
encompassing all methods for doing so.
With respect to the "infinite number of compounds" that may result in
overexpression, Appellants again state that Angstadt does not require
"disclosure of a test with every species covered by a claim." Appeal Br. 20
(quoting Angstadt, 537 F.2d at 502). But Appellants' argument-that
disclosure of one method for making a claimed product enables all methods
for making a claimed product in all cases-amounts to a per se rule that
neither Invitrogen nor Angstadt supports. The claims in Invitrogen were
sufficiently limited to genetically modified sequences, and the disclosure of
one means of creating those sequences (along with extensive knowledge of
other techniques in the art) sufficiently enabled the full scope of the claims.
But here, the claims are directed to genetically modified cells that
overexpress certain enzymes by any means (not limited to genetic-
modification of those enzymes' genetic sequences). Put differently, there is
a difference in kind between the claims of Invitrogen and the claims on
appeal that limits Invitrogen' s application here. And in Angstadt, the written
description disclosed a representative number of species within the claimed
genus; here, only one method is disclosed. For these reasons, the
enablement rejection is affirmed.
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D. Obviousness
The Examiner rejected claims 1-3, 6, 8, 9, and 14--15 under 35 U.S.C.
§ 103(a) for obviousness over Deng in view of Wahlund, Spreitzer, and
Amichay; and claims 1-3, 6, 8, 9, and 14--17 under 35 U.S.C. § 103(a) for
obviousness over Deng in view of Wahlund, Spreitzer, Amichay, Duhring,
and further in view of Kaneko.
Upon review of the Examiner's rejections, Appellants' arguments, and
the prior art, we determine that the weight of the evidence does not support
the obviousness rejections. Thus, we reverse the rejection of claims 1-3, 6,
8, 9, and 14--17 for obviousness.
The primary prior-art reference, Deng, provides "the first study in
which oxygenic photoautotrophic microorganisms," i.e., cyanobacteria,
"have been genetically engineered to produce ethanol." Deng 523.
Specifically, Deng introduced the coding sequences for pyruvate
decarboxylase (pdc) and alcohol dehydrogenase ( adh) from the bacterium
Zymomonas mobilis into a Synechococcus cyanobacterium, thus creating "a
novel pathway for fixed carbon utilization which results in the synthesis of
ethanol." Id. Deng does not disclose that overexpression of RubisCO can
increase production of ethanol. Thus, the Examiner relied on the secondary
references to teach that overexpression of RubisCO would have been
obvious to a skilled artisan. See Final Off. Act. 10.
Specifically, the Examiner relied on the disclosures of Wahlund and
Spreitzer to "provide the motivation to [over ]express a RubisCO nucleic
acid." Id. at 11. Wahlund inserted a plasmid expressing the pdc and adh
genes into Rhodobacter to achieve the bioconversion of carbon dioxide to
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Application 12/368,060
ethanol. Wahlund 1403---04. Spreitzer provides an overview ofRubisCO,
and proposes that a "better" RubisCO enzyme could be created through
genetic mutational approaches. Spreitzer 449, 465.
We decide this case by determining whether an ordinarily-skilled
artisan would have been motivated to increase the production of ethanol in
cyanobacteria, as taught by Deng, by overexpressing RubisCO. We agree
with Appellants that the Examiner did not adequately set forth a persuasive
reason explaining why a skilled artisan would have found it obvious to do
so. See Appeal Br. 23-26.
As Appellants point out, no reference teaches overexpression of
RubisCO. Id. at 23. The Examiner asserts, however, that
the teachings of Wahlund et al. and Spreitzer et al. provide the
motivation to increase expression of RubisCO in view of the
fact that Spreitzer et al. discloses that the first step in
photosynthetic carbon dioxide assimilation is catalyzed by
RubisCO and also in vie\v of the fact that \Vahlund et al. clearly
indicate that (i) there are numerous types of bacteria able to
carry out C02 fixation (like cyanobacteria) and that it would be
desirable to find ways to use C02 for the production of value-
added chemicals such as ethanol, and (ii) there is a considerable
interest in coupling pyruvate formation with ethanol synthesis
since pyruvate is a common metabolic intermediate of virtually
all central metabolic pathways in bacteria able to carry [out]
carbon dioxide fixation. As known in the art, C02 is a carbon
source for photosynthetic organisms, such as cyanobacteria. It
is reiterated herein that one of skill in the art would be
motivated to increase the expression of RubisCO for increased
C02 assimilation, which in tum would result in an increase in
the levels of metabolic intermediates such as pyruvate, a key
intermediate in the synthesis of ethanol.
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Application 12/368,060
Ans. 26. We find this explanation speculative at best. Although Spreitzer
teaches that RubisCO catalyzes the fixation of carbon dioxide, that
disclosure combined with the teachings of the other prior-art references does
not amount to sufficient evidence that overexpression of RubisCO for the
purpose of increasing ethanol production would have been obvious.
Obviousness based on an "obvious to try" rationale requires "a finite number
of identified, predictable solutions" and "known options within [the
ordinarily skilled artisan's] technical grasp." KSR Int'! Co. v. Teleflex Inc.,
550 U.S. 398, 416 (2007). Here, RubisCO is only one of several enzymes
involved in photosynthesis, and the Examiner has not persuasively explained
why the skilled artisan would choose RubisCO specifically (over, for
example, pyruvate decarboxylase and alcohol dehydrogenase ). Nor does the
Examiner provide any evidence supporting the theory that overexpression of
RubisCO would reasonably lead to the "anticipated success" of increased
ethanol production. Instead, the Examiner strings together a series of "if-
thens": if RubisCO is overexpressed then C02 assimilation would increase,
if C02 assimilation is increased then pyruvate levels would increase, and if
pyruvate levels are increased, then ethanol production will increase. Ans.
13. This speculation does not establish obviousness by a preponderance of
the evidence. For these reasons, the obviousness rejections are reversed.
SUMMARY
We affirm the final rejection of claim 8, 9, and 14 under 35 U.S.C.
§ 112, i-f 2, for indefiniteness, but reverse the final rejection under this
section of claims 1-3, 6, and 15-17.
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Appeal 2014-000811
Application 12/368,060
We affirm the final rejection of claim 1 under 35 U.S.C. § 112, i-f 1,
for lack of written description. Claims 2, 3, 6, 8, 9, 14, and 15 fall with
claim 1 as to this ground of rejection.
We affirm the final rejection of claim 1 under 35 U.S.C. § 112, i-f 1,
for lack of enablement. Claims 2, 3, 6, 8, 9, 14, and 15 fall with claim 1 as
to this ground of rejection.
We reverse the final rejections of claims 1-3, 6, 8, 9, and 14--17 under
§ 103(a) for obviousness.
TIME PERIOD FOR RESPONSE
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-IN-PART
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