Ex Parte Walker et al

Patent Trial and Appeal Board

Feb 28, 2018

12471273 (P.T.A.B. Feb. 28, 2018)

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.
12/471,273 05/22/2009 Keith A. Walker CIBUS-001-UT1 5556
35938 7590
Acuity Law Group, P.C.
12707 High Bluff Drive
Suite 200
San Diego, CA 92130-2037
EXAMINER
MCNEIL, STEPHANIE A N
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
03/02/2018 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):
docketing @ acuitylg.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KEITH A. WALKER, MARK E. KNUTH, NOEL M. FONG, and
PETER R. BEETHAM
Appeal 2016-005436
Application 12/471,2731
Technology Center 1600
Before TAWEN CHANG, TIMOTHY G. MAJORS, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a method of
producing squalene by a genetically altered yeast. The Examiner entered
final rejections for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE.
STATEMENT OF THE CASE
Background
Isoprenoids, such as squalene, are commercially
important types of lipids. They have excellent lubricity,
oxidative stability, low pour points, low freezing points, high
1 Appellants identify Cibus US LLC as the real party in interest. App. Br. 4.
Appeal 2016-005436
Application 12/471,273
flash points, and facile biodegradability. Squalene is currently
produced by extraction from olive oil or cold water shark liver
oil at a high unit cost. Because of the high unit cost,
economically feasible uses for squalene and squalane (the fully
hydrogenated derivative of squalene) are in small market
applications such as watch lubricants,
pharmaceuticals/nutraceuticals, cosmetics, perfumes and as
chemical intermediates for high-value products.
Spec. ^ 4.
There exist, however, significant potential markets for biodegradable
lubricants, lubricant additives, and hydraulic fluids. Id. ^\ 5.
Biodegradable lubricants, lubricant additives, and
hydraulic fluids derived from vegetable and animal fats and oils
are available, but they have drawbacks. They typically solidify
at relatively high temperatures (i.e., they solidify in cold
weather) and have flash points that are too low for use in hot
conditions, (i.e., they break down or combust under normal hot
engine conditions).
Thus, a cost effective method of production of squalene
is desired that would allow for large-scale manufacturing and
widespread use of squalene and squalane in biodegradable
lubricants, lubricant additives, and hydraulic fluids.
id. m 6-7.
The Specification discloses “compositions and methods for producing
squalene from yeast.” Id.*\\ 11.
Claims 4, 29-31, 44, and 51 are on appeal.2 App. Br. 4. Claim 4 is
illustrative and reads as follows:
4. A method of producing squalene by a genetically altered yeast,
said method comprising
increasing activity or expression of squalene synthase by
a yeast cell by introducing into the yeast cell (i) one or more
2 Claims 1-3, 5-28, 32^13, and 45-50 are cancelled. App. Br. 4.
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Appeal 2016-005436
Application 12/471,273
mutations into a squalene synthase gene of the yeast using a
gene repair oligonucleobase or (ii) an exogenous squalene
synthase gene, thereby genetically altering the yeast; and
selecting a yeast cell expressing squalene synthase
having the one or more mutations, or selecting a yeast cell
expressing the exogenous squalene synthase gene,
wherein said genetically altered yeast produces increased
quantities of squalene as compared to yeast expressing squalene
synthase which lacks the one or more mutations or yeast
lacking the exogenous squalene synthase gene.
App. Br. 12 (Claims Appendix).
Appellants seek our review of the rejection of claims 4, 29-31, 44,
and 51 under 35 U.S.C. § 103(a) as being unpatentable over Saunders,3
Dow,4 and Seo.5
DISCUSSION
The Examiner finds that Saunders, Dow, and Seo disclose a method
meeting all of the limitations of independent claim 4. Ans. 2-3. Specific to
the issues on appeal, the Examiner finds that Dow teaches “that to increase
yields of squalene in yeast, the amount of squalene synthase needs to be
increased.” Id. at 2. The Examiner further finds that Seo teaches that when
an “exogenous squalene synthase gene [is inserted] into E. senticosus,
resulting in transgenic E. senticosus. . . the transgenic E. senticosus
3 U.S. 5,460,949, issued Oct. 24, 1995 (“Saunders”).
4 Dow AgroSciences LLC, Using Yeast Fermentation to Produce Cost-
Effective and Biodegradable Lubricants (2004) (“Dow”).
5 Jin-Wood Seo, et al., Overexpression of squalene synthase in
Eleutherococcus senticosus increases phytosterol and triterpene
accumulation, 66: Phytochemistry 869-877 (2005) (“Seo”).
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Appeal 2016-005436
Application 12/471,273
expressed more than twice as much squalene.” Id. at 3. The Examiner
observes that
While Seo states in the body of the report “squalene levels were
similar in transgenic and wild-type cells” (see col. 1 on page
873), the graph showing the squalene levels in wild type and
transgenic plants in Figure 7b shows that the levels in the
transgenic plants were more than 2-fold greater than the levels
in the wild type plants.
Id.
In making these findings, the Examiner finds that the ordinarily
skilled artisan
would have had a reasonable expectation of success in
modifying Saunders’ method of squalene production through
transforming yeast with mutated copies of enzymes involved in
isoprenoid biosynthesis, to also include transforming yeast with
Se[o]’s squalene synthase as to increase its squalene production
because Dow AgroSciences LLC teaches squalene synthase
levels should be increased in order to increase squalene
production in yeast and also Seo teaches that addition of
exogenous squalene synthase increases squalene production.
Id. at 3.
Appellants argue, among other points, that the skilled artisan “would
lack any reasonable expectation of success in modifying these references to
arrive at the claimed invention.” App. Br. 9. Appellants argue that Saunders
“states that specific alterations in the sterol pathway are unpredictable, and
follows this by providing one method to achieve the result of increased
sterol accumulation.” Id. at 8. Appellants argue that Dow discloses
“Squalene epoxidase and Squalene synthetase were not manipulated
successfully” and that Dow’s project was ultimately abandoned “with Dow
AgroSciences believing that the gene manipulations could not be
performed.” Id. at 9. Appellants further argue that Dow “would seem to
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Application 12/471,273
confirm the conclusion of the primary Saunders et al. reference that specific
alterations in the sterol pathway are unpredictable, and further emphasize
this fact with regard to squalene epoxidase and squalene synthase.” Id.
Appellants further argue that Seo’s “relevance ... is not apparent” because
“A. senticosus is a plant and not a yeast.” Id. Further, according to
Appellants, Seo discloses ‘“squalene levels were similar in transgenic and
wild-type cells’,” which Appellants argue is evidence of unpredictability in
pursuing the claimed method. Id.
The Examiner responds that Saunders’ comment about
unpredictability was background information and that Saunders teaches “that
one can achieve predictable results.” Ans. 5. The Examiner further finds
that Dow’s decision not to pursue the project was an issue of potential
commercial success and “does not mean that squalene synthase cannot be
manipulated.” Id. at 6. Further, the Examiner argues, “Seo teaches
modifying the same pathway as the pathways taught by Saunders and Dow
AgroSciences LLC, and therefore Seo is analogous art” despite that it
regards plants and not yeast. Id.
In reply, the Appellants reiterate that the teachings of the references
would discourage the skilled artisan from pursuing the claimed method.
Reply Br. 3-6. The Appellants conclude “to the limited extent one might
predict anything from the art of record in the rejection, it would be that
simply increasing squalene synthase should have no effect, or, even worse,
an unpredictable effect, on squalene production.” Id. at 6.
The issue with respect to this rejection is whether the teachings of
Saunders, Dow, and Seo would have provided the ordinarily skilled artisan
with a reasonable expectation of success in practicing the claimed method.
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Application 12/471,273
“Where claimed subject matter has been rejected as obvious in view
of a combination of prior art references, a proper analysis under § 103
requires, inter alia, consideration of two factors: (1) whether the prior art
would have suggested to those of ordinary skill in the art that they should
make the claimed composition or device, or carry out the claimed process;
and (2) whether the prior art would also have revealed that in so making or
carrying out, those of ordinary skill would have had a reasonable expectation
of success. Both the suggestion and the reasonable expectation of success
must be founded in the prior art, not in the applicant’s disclosure.” In re
Vaeck, 947 F.2d 488, 493, (Fed. Cir. 1991) (citation omitted). A “finding of
a reasonable expectation of success is a question of fact.” Medichem S.A. v.
Rolabo S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006).
While we agree that the Examiner’s findings are based in fact and
view this as a close case, on balance we are persuaded by Appellants that on
the record before us, an ordinarily skilled artisan would not have held a
reasonable expectation of success in achieving the claimed method. In
particular, we are persuaded by Dow’s teachings on the difficulties
encountered in attempting to manipulate the squalene synthetase gene and
the absence of production of squalene itself. Dow 2—4. Although we also
acknowledge the limited success observed by Seo in producing squalene in
plants, absent other evidence of success in the production of squalene in
yeast, we are not persuaded that the facts support a reasonable expectation of
success on this record.
“An examiner bears the initial burden of presenting a prima facie case
of obviousness.” In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir.
2011). As we find the Examiner has not established that the ordinarily
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Application 12/471,273
skilled artisan would have had a reasonable expectation of success in
practicing the claimed method, we reverse the rejection under 35 U.S.C.
§103 over claim 4, and all of the dependent claims.
SUMMARY
We reverse the rejection of all claims.
REVERSED
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