Ex Parte Reuter et al

Patent Trial and Appeal Board

Jan 28, 2019

14211078 (P.T.A.B. Jan. 28, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/211,078 03/14/2014
35684 7590
BUTZEL LONG, P.C.
IP DEPARTMENT
41000 Woodward A venue
Stoneridge West
Bloomfield Hills, MI 48304
01/30/2019
FIRST NAMED INVENTOR
Christopher J. Reuter
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.
141499-0061 7026
EXAMINER
FERNANDEZ, SUSAN EMILY
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
01/30/2019 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):
PA TENT@BUTZEL.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHRISTOPHER J. REUTER,
STEVEN J. MACKENZIE, LAUREN G. DANIELSON, and
VINCENT SCUILLA 1
Appeal2018-000260
Application 14/211,078
Technology Center 1600
Before DONALD E. ADAMS, TA WEN CHANG, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of inhibiting gram negative microorganisms, which have been
rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
STATEMENT OF THE CASE
According to the Specification, pathogenic microorganisms, such as
Vibrio species that are pathogenic to fish and shellfish, cause major losses in
1 Appellants identify the Real Party in Interest as Osprey Biotechnics, Inc.
(Appeal Br. 3.)
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Application 14/211,078
aquaculture fanning. (Spec. ,r 6.) "Thus, it is important to provide new and
effective [bacterial] strains that have antibacterial activity against specific
disease-causing microbes affecting the aquaculture industry." (Id.)
"Bacillus amyloliquefaciens is a gram-positive non-pathogenic soil
bacterium" that is "known for its ability to degrade proteins extracellularly."
(Id. ,r 3.) The Specification states that a novel strain of Bacillus
amyloliquefaciens has been identified and isolated and further states that the
strain is "characterized by its ability to inhibit the growth and/or activity of
gram negative microorganisms, such as ... Vibrio .... " (Id. ,r 7.)
Claims 15, 21, and 22 are on appeal. Claim 15 is illustrative and
reproduced below:
15. A method of inhibiting gram negative microorganisms,
compnsmg:
adding to a material contaminated with a pathogenic
gram negative microorganism an amount of Bacillus
amyloliquefaciens strain OBT712 as deposited with the
American Type Culture Collection under accession number
PTA-122189 that produces enzymes, metabolites or antibiotics
that inhibit growth of gram negative pathogenic
microorganisms that is effective to inhibit the gram negative
microorganism, wherein the Bacillus amyloliquefaciens strain
OBT712 is applied to containments in which shrimp or fish are
farmed to reduce incidents of Vibrio, wherein the Bacillus
amyloliquefaciens strain OBT712 is added in a live vegetative
state.
(Appeal Br. 11 (Claims App.).)
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Application 14/211,078
The Examiner rejects claims 15, 21, and 22 under 35 U.S.C. § 103 as
being unpatentable over Villamar2 and Terhune. 3 (Ans. 5.)
The Examiner rejects claim 22 under 35 U.S.C. § 103 as being
unpatentable over Terhune and Harel. 4 (Ans. 2.)
DISCUSSION
Issue
The Examiner has rejected claims 15, 21, and 22 as obvious over
Villamar and Terhune and rejected claim 22 as obvious over Terhune and
Harel. The same issues are dispositive for both rejections; we therefore
discuss them together.
The Examiner finds that Villamar suggests all of the limitations of the
claims except that it does not expressly disclose the specific Bacillus species
or strain recited in the claims. (Ans. 5-8.) However, the Examiner finds
that Terhune teaches treating or preventing diseases caused by pathogenic
bacteria or fungi by administering Bacillus strains to an environment such as
a pond or to aquatic animals such as farmed fish and crustaceans ( e.g.,
shrimp). (Id. at 8.) The Examiner further finds that Terhune teaches that
suitable strains for its invention include Bacillus amyloliquefaciens strains
AP79 (NRRL B-50741), API43 (NRRL B-50742), API93L (NRRL B-
50743), and AP254L (NRRL B-50745), which exhibit "antibiotic activity in
various bacterial pathogens of aquatic animals such as farmed fish and
crustaceans (e.g.[,] shrimp)." (Id. at 8-9.) The Examiner finds that the B.
2 Villamar et al., US 2004/0009160 Al, published Jan. 15, 2004 (hereinafter
"Villamar").
3 Terhune et al., US 2012/0328572 Al, published Dec. 27, 2012 (hereinafter
"Terhune").
4 Harel, WO 03/103692 Al, published Dec. 18, 2003.
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amyloliquefaciens strains disclosed in Terhune "each appear to be identical
to the presently claimed OBT712 strain based on the fact that the
microorganisms of Terhune are of the same species and have the same
property of inhibiting the growth of Vibrio." (Id. at 9.)
The Examiner concludes that it would have been obvious to a skilled
artisan to combine Villamar and Terhune to arrive at the claimed invention,
with a reasonable expectation of success, by using dried vegetative cells of
Bacillus amyloliquefaciens, as taught by Terhune, when practicing
Villamar's method of inhibiting Vibrio in order to prevent diseases in
aquatic species. (Id. at 9--10.) The Examiner finds that it would have been
obvious to use B. amyloliquefaciens cells in Villamar's method, with a
reasonable expectation of success, because Villamar teaches "selecting the
Bacillus of [its] invention on the basis of producing antibiotic to inhibit or
kill pathogenic bacteria such as Vibrio," and Terhune's B. amyloliquefaciens
strains are expected to exhibit antibiotic activity against Vibrio. (Id.)
With respect to claim 22, the Examiner also finds that Terhune
teaches all of the limitations of the claim, except that it does not "expressly
disclose providing any one of their B. amyloliquefaciens strains to rotifers
that become food for the shrimp or fish." (Ans. 3.) The Examiner finds,
however, that Harel teaches a method of delivering live, bioactive probionts
or prebionts to fish and crustaceans, comprising feeding to such fish and
crustaceans zooplankton comprising the probiont or prebionts. (Id.) The
Examiner also finds that Harel teaches that the zooplankton can be rotifers
and that the probiotics or prebiotics may be Bacillus. (Id. at 4.)
The Examiner concludes that it would have been obvious to a
skilled artisan to combine Terhune and Harel to arrive at the invention
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of claim 22, with a reasonable expectation of success, by providing
the B. amyloliquefaciens strains disclosed in Terhune to fish and
shrimp through rotifers (i.e., by feeding the strains to rotifers and then
feeding the rotifers to shrimp and fish). (Id. at 4.) The Examiner
finds that
(Id.)
[ t ]here would have been a reasonable expectation of success in
treating or preventing disease in the aquatic animals by Vibrio
via this modification since Harel indicates that its technique is
suitable for delivering probionts such as Bacillus sp. while
maintaining the probionts' viability and/or bioactivity, [as] well
as being suitable for improving the survival rate of breeding
larvae and juvenile fish.
For both rejections, Appellants contend that the cited prior art
combinations do not suggest the claimed methods because the claimed
OBT712 strain is not anticipated by Terhune. (Appeal Br. 7-8.)
The issue with respect to this rejection is whether the cited prior art
combinations suggest the use of the claimed OBT712 strain.
Analysis
We agree with the Examiner that claims 15, 21, and 22 are obvious
over Villamar and Terhune and claim 22 is obvious over Terhune and Harel.
Only those arguments timely made by Appellants in the briefs have been
considered; arguments not so presented are waived. See 37 C.F.R.
§ 4I.37(c)(l)(iv) (2015); see also Ex parte Borden, 93 USPQ2d 1473, 1474
(BP AI 2010) (informative) ("Any bases for asserting error, whether factual
or legal, that are not raised in the principal brief are waived.").
Appellants' sole argument in the Appeal Brief as to both rejections
rests on a comparison of Figure 1 of Appellants' application, which shows
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the I6S rDNA sequence for the claimed OBT712 strain, and Terhune's SEQ
ID N0:2, which is a partial sequence of the 16S rDNA of the B.
amyloliquefaciens strain Chilli-I. (Appeal Br. 7-8.) Appellants contend
that, because the comparison shows that the sequences are not identical, the
claims are not obvious over the combinations of Terhune and Villamar or
Hare 1. (Id.)
We do not find this argument persuasive. As the Examiner points out
in the Answer, Terhune does not teach that Bacillus species useful in its
invention must include a sequence identical to SEQ ID N0:2. (Ans. 11.)
Instead, Terhune teaches that "[t]he disclosed compositions and methods
may include or utilize B. amyloliquefaciens or a Bacillus species that is
closely related to B. amyloliquefaciens," wherein the latter is defined as "a
species comprising a 16S rDNA sequence comprising SEQ ID N0:2 or
comprising a 16S rDNA sequence having at least about 90% ... sequence
identity to SEQ ID NO: 2." (Terhune ,r 21.) In short, Terhune suggests a
genus of Bacillus would be useful in its method of treating or preventing
disease in fishes or crustaceans so long as it belongs to the B.
amyloliquefaciens species or comprises a 16S rDNA sequence having at
least about 90% sequence identity to SEQ ID N0:2. We find that OBT712
is a strain of B. amyloliquefaciens within the genus of B. amyloliquefaciens
that Terhune suggests would be useful in its method for the reasons that
follow.
A comparison of the 16S rDNA in Figure 1 of the Specification and
Terhune's SEQ ID N0:2 shows that, out of the 525 overlapping nucleotides
between the I6S rDNA sequence of the claimed OBT712 strain and SEQ ID
N0:2, only eight nucleotides are different. Thus, the sequence identity of
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OBT712 to SEQ ID N0:2 is at least about 90% identical. Moreover, the
claim indicates that OBT712 is a B. amyloliquefaciens strain.
Given that the claims explicitly recite OBT712 strain as a B.
amyloliquefaciens strain and given the substantial similarity between (a) the
16S rDNA sequence for the claimed OBT712 strain as shown in Figure 1
and (b) Terhune's SEQ ID N0:2, we find that the Examiner has established
a prima facie case that Terhune suggests that the OBT712 strain when added
to a material contaminated with Vibrio would result in inhibition of those
gram negative microorganisms as required by the claims. This is true even
if OBT712 is a previously unknown strain of B. amyloliquefaciens.
Compare In re Kaufmann, 451 F.2d 1096, 1098 (CCPA 1971) (affirming
rejection of claims to a process for producing a compound using Proteus
OX-19, a particular penicillin acylase-producing strain of a Proteus species,
where the prior art generally discloses producing the same compound using
penicillin acylase-producing strains of several genera, including the genus
Proteus) with In re Pleuddemann, 910 F.2d 823, 826-828 (Fed. Cir. 1990)
(reversing an obviousness rejection where the prior art did not make it
obvious to use a new compound because the functioning of the new
compound was not suggested by the prior art).
Appellants have not persuasively identified any error by the Examiner
or otherwise persuasively rebutted the prima facie case. 5 An earlier
5 Both Figure 1 of the Specification and Terhune's SEQ ID N0:2 appear to
only be partial sequences. (Spec. ,r 9 ( describing Figure 1 as the "relevant"
sequence for B. amyloliquefaciens strain OBT712); Terhune ,r 21 (stating
that SEQ ID N0:2 is a "partial" sequence of B. amyloliquefaciens strain
Chilli-I I6S rDNA).) Thus, each contains nucleotide sequences before or
after the overlapping portion that do not appear in the other. We also
acknowledge that Terhune describes specific methods for determining
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disclosure of a genus does not necessarily prevent patenting a species
member of the genus, for instance if the species exhibits unexpected results.
Abbvie Inc. v. Mathilda and Terence Kennedy Institute of Rheumatology
Trust, 764 F.3d 1366, 1380 (Fed. Cir. 2014). However, Appellants have not
presented any evidence of unexpected results.
In the Reply Brief, Appellants contend that "[t]he Examiner's
argument [in the Answer] is inconsistent with the Examiner's previously
stated rationale for the rejection." (Reply Br. 2-3.) However, this
contention relates to a petitionable matter and not to an appealable matter.
See MPEP § 1002.02(c)(6).
Finally, Appellants argue in the Reply Brief that, putting aside the
comparison of Specification's Figure 1 and Terhune's SEQ ID N0:2, there
is simply insufficient basis for concluding that any of the AP79, AP143,
AP193L or AP254L strains is identical to the OBT712 strain recited in the
claims. (Reply Br. 3-5.) We are not persuaded for the same reasons already
discussed: Terhune's teaching is not limited to the four B.
amyloliquefaciens strains explicitly recited. Rather, as discussed above,
Terhune teaches that its methods may use B. amyloliquefaciens generally or
a Bacillus species that is closely related to B. amyloliquefaciens. (Terhune
"percentage sequence identity" rather than simply comparing them side by
side. (Terhune ,r,r 23-24.) However, in light of the substantial similarity of
the overlapping portion of the two sequences discussed above, we find that
the Examiner has met the burden of presenting a prima facie case of
unpatentability. Cf In re Best, 562 F.2d 1252, 1255 (CCPA 1977) ("Where
... the claimed and prior art products are identical or substantially identical
... the PTO can require an applicant to prove that the prior art products do
not necessarily or inherently possess the characteristics of his claimed
product.")
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,r 21.) Thus, the fact that the claimed OBT712 strain is not identical to one
of AP79, AP143, AP193L, or AP254L does not suffice to show that the
claims are not obvious.
Accordingly, we affirm the Examiner's rejections of claims 15, 21,
and 22 as obvious over Villamar and Terhune and claim 22 as obvious over
Terhune and Hare 1.
SUMMARY
For the reasons above, we affirm the Examiner's rejection of claims
15, 21, and 22.
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
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