Ex Parte LeBrun et al

Patent Trial and Appeal Board

Aug 21, 2018

13773971 (P.T.A.B. Aug. 21, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/773,971 02/22/2013 Jeffrey Richard LeBrun
86225 7590 08/23/2018
NYEMASTER GOODE P.C.
700 Walnut Street, Suite 1600
Des Moines, IA 50309-3899
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.
3007239-1031 (KEM 280) 3197
EXAMINER
HENRY, MICHAEL C
ART UNIT PAPER NUMBER
1673
NOTIFICATION DATE DELIVERY MODE
08/23/2018 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):
ptomail@nyemaster.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JEFFREY RICHARD LeBRUN, ROBERT LEVINE,
and GEOFFREY PAUL HORST 1
Appeal2017-002781
Application 13/773,971
Technology Center 1600
Before DONALD E. ADAMS, ERIC B. GRIMES, and RYAN H. FLAX,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an animal
feed product, which have been rejected as obvious and as directed to patent-
ineligible subject matter. We have jurisdiction under 35 U.S.C. § 6(b ).
We reverse.
STATEMENT OF THE CASE
"An over-dependence upon antibiotics in modem agriculture and
human health has led to widespread antibiotic resistance and led to a desire
1 Appellants identify the Real Party in Interest as Algal Scientific
Corporation. Appeal Br. 2.
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Application 13/773,971
for more natural ways to promote healthy immune function." Spec. ,r 4.
"An example of a compound used to stimulate immune system activity is
beta glucan." Id. ,r 7.
"Beta glucan products are currently derived primarily from yeast." Id.
The Specification discloses "a composition comprising an effective amount
of beta glucan produced by an algae or protist such as Euglena, where the
composition is used to improve the well-being of an animal. Lower-cost
beta glucan feed additives produced using algae therefore provide affordable
and natural alternatives to antibiotics." Id. ,r 19. "The beta glucan produced
by Euglenoids is unique in its physical characteristics and is often referred to
as 'paramylon. '" Id. ,r 46.
"Euglena are capable of heterotrophic and photosynthetic
metabolisms." Id. ,r 64. For example, "Euglena gracilis can be grown
heterotrophically in a controlled environment (through the manipulation of
carbon source, nutrient levels, pH, temperature, and other factors),
centrifuged or filtered to remove it from the water, and dried." Id. ,r 80.
Claims 17, 21, 24--26, 28, 40, 41, 45, and 49 are on appeal. Claim 17
is the only independent claim and reads as follows:
Claim 17: An animal feed product comprising (i) heterotrophically grown
Euglena comprising greater than 20 weight% beta-(1,3)-glucan, wherein the
Euglena is grown and fermented in a fermenter under sterile conditions and
dried to contain less than 10% moisture, and (ii) an animal feed component,
wherein the beta-(1,3)-glucan is present in an amount from 0.001 % to
0.020% of the total weight of the animal feed product, and wherein the
animal feed product is ingestible.
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The claims stand rejected as follows:
Claims 17, 21, 26, 28, and 45 under 35 U.S.C. § 101 as being directed
to patent-ineligible subject matter (Ans. 2);
Claims 17, 21, 24, 26, 28, 40, 41, and 45 under 35 U.S.C. § I03(a) as
obvious based on Tuse, 2 Hayen, 3 and Takigawa4 (Ans. 4);
Claim 25 under 35 U.S.C. § I03(a) as obvious based on Tuse, Hayen,
Takigawa, and Matsuoka5 (Ans. 4); and
Claim 49 under 35 U.S.C. § I03(a) as obvious based on Tuse, Hayen,
Takigawa, and Shi6 (Ans. 4).
I
The Examiner has rejected claims 17, 21, 26, 28, and 45 under 35
U.S.C. § 101, on the basis that:
The claims are drawn to a composition that has natural products
as a claim limitation. . . . [T]his natural product is a judicial
exception(s) that is recited or involved in the claim, and the
features ... in addition to the judicial exception(s)[] in the
claim do not result in the claim as a whole reciting something
significantly different than the judicial exception itself.
Ans. 2-3. Specifically,
the use of animal feed component( s) which includes substances
such as water, nutrients or supplements such as mineral and
vitamins in the composition is common in the art, ... [ and]
there is no significant difference between the claimed product
2 US 5,084,386; Jan. 28, 1992.
3 US 6,214,337 Bl; Apr. 10, 2001.
4 JP 2001275654 (A); Oct. 9, 2001. The record copy of Takigawa is in
Japanese, but includes an English abstract.
5 US 5,174,821; Dec. 29, 1992.
6 US 2010/0272940 Al; Oct. 28, 2010.
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and the naturally occurring product comprising the same
compounds of the same structure.
Id. at 3.
Appellants argue:
Dr. Horst indicates that the Euglena recited in claim 17 is
grown differently than Euglena found in nature, and is also
structurally different from Euglena found in nature ....
Fermentation makes it possible to grow Euglena having more
than 20 weight% beta-(1,3)-glucan .... In contrast, Euglena
found in nature that has been dried to contain less than 10%
moisture does not have more than 20 weight% beta-(1,3)-
glucan. Thus, the Euglena recited in claim 17 is structurally
distinct from Euglena found in nature.
Appeal Br. 3, citing the Horst Declaration. 7 Appellants also argue that
"[b] ecause the E ugl ena recited in claim 1 7 contains a higher amount of beta-
(1,3 )-glucan than Euglena found in nature, the Euglena recited in claim 17
has higher potency than Euglena found in nature. As such, the Euglena
recited in claim 17 is also functionally different from Euglena found in
nature." Id. at 4.
We agree with Appellants that the rejection is not supported by a
preponderance of the evidence. See In re Oetiker, 977 F.2d 1443, 1445
(Fed. Cir. 1992) ("[T]he examiner bears the initial burden, on review of the
prior art or on any other ground, of presenting a prim a f acie case of
unpatentability .... After evidence or argument is submitted by the
applicant in response, patentability is determined on the totality of the
7 Declaration under 37 C.F.R. § 1.132 of Geoffrey Horst, filed Nov. 16,
2015.
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record, by a preponderance of evidence with due consideration to
persuasiveness of argument.").
Here, Appellants have submitted declaratory evidence to show that
"the Euglena of the current claims differs from Euglena found in nature."
Horst Deel. ,r 3. That is, "Euglena found in nature does not grow by
fermentation, nor under sterile conditions, and has not been dried to contain
less than 10% moisture and to have more than 20 weight % beta-(1,3)-
glucan. As such, [Dr. Horst] believe[s] that the Euglena of the current
claims is structurally different from Euglena found in nature." Id. ,r 4. More
specifically, "[t]he Euglena of the current claims is golden-yellow in color,
as a product of fermentation. In contrast, Euglena found in nature is green
in color, as a product of photosynthesis." Id. ,r 5.
Dr. Horst's testimony is consistent with the Specification's disclosure.
See Spec. ,r 23 ("Under optimized growth conditions, it is possible to achieve
concentrations of beta glucan where the net beta glucan weight is greater
than 20% to 80% of the total dry weight proportion of the biomass."
( emphasis added)); id. ,r 94 ("The Euglena can also be grown in an optimal
manner such that the beta glucan portion of the algae product comprises
greater than 20% of the algae biomass, as measured on a dry weight basis.").
The Examiner responded that, "although Appellant claims that the
Euglena is fermented, the said fermented Euglena is not considered different
from the Euglena that occurs in nature especially since it is still referred to
as Euglena." Ans. 11. The Examiner states that "it does not matter how the
Euglena is grown, especially since it occurs in nature. The declaration has
not indicated or provide any convincing data or information which clearly
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indicates that the claimed fermented Euglena is different from the Euglena
that occurs in nature." Id. at 12.
Appellants, however, have presented evidence that the Euglena
recited in the claims differ from Euglena as they occur in nature. Dr. Horst
has testified that Euglena found in nature is structurally different from the
Euglena recited in the claims, at least because naturally occurring Euglena
do not have more than 20 weight % B-(1,3)-glucan and are a different color
from the Euglena required by the claims. The Examiner has not pointed to
evidence supporting a contrary finding.
The Examiner, however, reasons that "different species of Euglena
would be expected to have different% by weight ofbeta-(1,3)-glucan such
as more than 20 weight% beta-(1,3)-glucan." Ans. 13. The Examiner
directs attention to Valensa, 8 "which indicates that Euglena having 65%
weight beta-(1,3)-glucan ... can be obtained from nature or a natural source
without any additional processing." Id.
These lines of reasoning do not persuade us that the rejection is
supported by a preponderance of the evidence. The Examiner does not point
to any evidence of a species of Euglena having more than 20 weight% beta-
(1,3)-glucan as it occurs in nature. Regarding Valensa, we do not find the
evidence persuasive as support for the Examiner's position. Valensa
discloses "a proprietary, new form of beta glucan for the human health
8 Valensa International, "Valensa Introduces 1,3 Beta Glucan Targeting
Immune Health Formulations," http://www. pmewswire. com/news-
releases/valensa-introduces-13-beta-glucan-targeting-immune-health-
formulations-277583101.html. The Examiner made the reference of record
as an appendix to the Office Action mailed Oct. 19, 2016.
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market. Called IMMUNUMâ„¢ PRO, the new ingredient is a harvested
Euglena algae that delivers 2:65% 1,3 beta glucan by weight - the highest
level of beta glucan provided by any natural source without additional
processing." Valensa 1. However, Valensa also states that "IMMUNUM
PRO harvesting is carried out via a proprietary closed-reactor technology for
growing Euglena algae with a high 1,3 beta content." Id. at 2. Thus,
Valensa does not provide evidence that Euglena grown under natural
conditions has a B-(1,3)-glucan content of more than 20 weight%.
In summary, we conclude that the rejection under § 101 is not
supported by a preponderance of the evidence of record. We therefore
reverse that rejection.
II
The Examiner has rejected all of the claims as obvious based on Tuse,
Hayen, and Takigawa, either by themselves or combined with either
Matsuoka or Shi. The same issue is dispositive for all of the obviousness
rejections.
The Examiner finds that Tuse discloses beta-(1,3)-glucan obtained
from Euglena. Ans. 4. The Examiner finds that Tuse also discloses that
beta-(1,3)-glucan is an immunostimulant (id. at 5) and discloses
compositions comprising 0.01 to 1.0% by weight beta-(1,3)-glucan (id. at 4).
The Examiner also finds that Tuse discloses that Euglena can be grown so
that "the cell mass of the Euglena compris[ es] 70% to 90% beta-1,3-glucan
... on a dry weight basis." Id. at 5.
The Examiner finds that Tuse does not disclose an animal feed
composition that comprises Euglena cells, but Hayden discloses that "a beta-
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glucan can be added to an animal feed that is administered to animals" and
Takigawa discloses that "Euglena algae (algae biomass) are edible algae that
can be used as food proteins and livestock feed (animal feed)." Id. at 5---6.
The Examiner concludes that the claimed product would have been obvious
based on these disclosures. Id. at 6-7.
Appellants argue, among other things, that they have presented
evidence that "low doses ofbeta-(1,3)-glucan unexpectedly provide a more
positive effect on animal health than do larger amounts ofbeta-(1,3)-
glucan." Appeal Br. 8. Appellants cite the Levine Declaration9 as evidence
that the dose of Euglena beta-(1,3)-glucan recited in the claims results in
better feed conversion ratios and antibody titers when it was included in
animals' feed. Id. at 8-10.
The Levine Declaration presents data from three experiments. In
Example 1, chickens were fed a feed preparation containing no beta glucan
( control), or containing Euglena beta glucan at either 0.009 wt% or 0.026
wt%. Id. ,r 6.1.1. "Body weight and feed conversion ratios were calculated
at days 14, 28, and 42." Id. ,r 6.1.2. The results showed that "[b ]roilers fed
beta glucan at an inclusion ration of 90 g/ton [0.009 wt%] showed a
significant decrease (p<0.05) in mortality corrected feed conversion ratio in
the starter diet as compared to the control diet, whereas broilers fed 260
g/ton [0.026 wt%] beta glucan did not show significant improvement." Id.
,r 6.1.6.
Dr. Levine concludes from these data that
9 Declaration under 37 C.F.R. § 1.132 of Robert Levine, filed Oct. 30, 2014.
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the dose-response relationship for beta glucan from Euglena is
not a simple linear function where more is better-rather, there
is a very narrow window in which the beta glucan has an
optimal effect and above this window there is no positive effect
or there can be a negative effect. The present invention in
related to using beta glucan from Euglena within this narrow
window.
Id. In the same experiment, the chickens were given Newcastle/Bronchitis
vaccine and "[b ]irds fed diets containing 90 g/ton beta glucan showed a
significantly higher level of antibody titers than the control diet at day 25,
whereas broilers fed 260 g/ton beta glucan did not show significant
improvement in antibody levels compared to the control." Id. ,r,r 6.1.3,
6.1.8. Dr. Levine concludes that "low doses of B-1,3-glucan from Euglena
unexpectedly improves animal health. Id. ,r 6.2.
The Levine Declaration also describes a second experiment, in which
chickens were fed different amounts ofbeta-(1,3)-glucan from Euglena. Id.
,r,r 7.1-7.8. Dr. Levine testified that "[t]reatment 2, which received 45 g/MT
[0.0045 wt%] beta glucan for the full 49 days, demonstrated the largest
improvement in performance relative to the control group (treatment 1 ): the
growth rate was 3.4% faster and the mortality-adjusted feed conversion ratio
was 1.9% lower." Id. ,r 7.3. Dr. Levine states that, "[fJor a commercial
producer, this is a tremendous improvement that is highly sought after in a
competitive marketplace." Id.
In the same experiment,
treatment 6, [using] 180 g/MT [0.018 wt%] beta glucan in the
starter diet and no subsequent exposure resulted in an overall
3.4% improvement in growth rate with a 0.5% mortality
adjusted improvement in the FCR [ feed conversion ratio]. For
treatment 7, when 90 g/MT [0.009 wt%] beta glucan was used
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in the starter, 45 g/MT [0.0045 wt%] in the grower, and none in
the finisher feed, overall growth rates were increased 2.0% and
mortality adjusted FCR was improved 0.2% relative to the
control.
Dr. Levine testified that "the use of beta glucan at only low doses (i.e.,
45 g/MT) or at moderately higher doses for just a brief time (i.e., 180 g/MT
for the first two weeks of life) has surprisingly been found to improve feed
efficiency and increase growth rates in animals." Id. ,r 7 .8.
Finally, the Levine Declaration reports an experiment in which pigs
were "vaccinated with Porcine circovirus type 2 (PCV2) and M
hyopneumoniae vaccines" and then fed one of five diets: "(1) a negative
control diet; (2), (3), (4) and (5) were the [same] diet with 45, 90, 180,
260 g/MT beta glucan added." Id. ,r 8.1. Antibody titers were later
measured. Id. ,r 8.2. The results showed that "[t]he treatment group
receiving 45 g/MT beta glucan showed the greatest numerical increase in
antibody titers compared to the control group." Id. Dr. Levine testified that
Id.
[t]his result was unexpected, since with the increasing inclusion
of beta glucan was thought to increase specific immune
response. These data show again that at low doses of beta
glucan from Euglena, immunomodulation that conferred a
positive benefit on the animal was unexpectedly achieved. In
contrast, at higher doses of beta glucan (in this case, above 180
g/MT) there was actually a negative effect.
Thus, Appellants' evidence shows that feeding animals a diet
containing beta-(1,3)-glucan from Euglena at doses within those recited in
claim 17-specifically 0.0045 wt%, 0.009 wt%, and 0.018 wto/o-resulted in
higher feed conversion ratios and higher antibody titers when compared to
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animals fed a diet containing either no beta-(1,3)-glucan or a diet containing
beta-(1,3)-glucan at a dose higher than what is recited in claim 17. Dr.
Levine testified that these results were unexpected and commercially
significant.
The Examiner responded to Appellants' unexpected results argument
and evidence as follows:
[A] 260 g/ton beta glucan is 0.026% ... which is significantly
or substantially close to (especially within experimental error)
the claimed range of 0.001 % to 0.02% recited in Appellant[s']
claims. That is, Appellant's arguments or declaration which are
presented to show unexpected or unforeseen results is not
commensurate with the scope of the claims or convincing. It
should be noted that if appellant intends to rely on unexpected
or unforeseen results, attention is invited to M.P .E.P. § 716.
Absent clear, convincing, side-by-side data demonstrating
unobviousness vis-a-vis the prior art commensurate with the
scope of protection sought, the claims are considered prima
facie obvious. Thus, the [Levine] Declaration ... is insufficient
to overcome the ... 103(a) rejections.
Ans. 24.
We agree with Appellants that the rejections on appeal are not
supported by a preponderance of the evidence of record. As discussed above,
the Levine Declaration presents evidence that animals fed a diet containing
beta-(1,3)-glucan from Euglena at doses ranging from 0.0045 wt% to 0.018
wt% showed higher feed conversion ratios and higher antibody titers,
compared to animals fed a diet without beta-(1,3)-glucan or a diet containing
higher levels ofbeta-(1,3)-glucan than required by the claims. See In re
Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) ("If an applicant
demonstrates that an embodiment has an unexpected result and provides an
adequate basis to support the conclusion that other embodiments falling
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within the claim will behave in the same manner, this will generally establish
that the evidence is commensurate with [the] scope of the claims.").
The Examiner's reasoning does not show that Appellants' evidence is
not commensurate in scope with the claims. If anything, the fact that
Appellants' comparison was to an amount ofbeta-(1,3)-glucan that is close
to--but not within-the claimed range shows the criticality of including
beta-(1,3)-glucan from Euglena within the dosage range recited in the claims
in order to increase feed conversion ratios and antibody titers. Thus, we
conclude that the § 103 rejections on appeal are not supported by a
preponderance of the evidence of record.
SUMMARY
We reverse all of the rejections on appeal.
REVERSED
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