Ex Parte Lin et al

Patent Trial and Appeal Board

Aug 2, 2016

13608557 (P.T.A.B. Aug. 2, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/608,557 09/10/2012
49455 7590 08/04/2016
STEIN IP, LLC
1400 EYE STREET, NW
SUITE 300
WASHINGTON, DC 20005
FIRST NAMED INVENTOR
Jhy-JhuLin
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.
0347.1002CIPD1Cl 5498
EXAMINER
WARE, DEBORAH K
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
08/04/2016 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):
docketing@steinip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JHY-JHU LIN and JO LINT A LIN
Appeal2014-006330
Application 13/608,557
Technology Center 1600
Before JEFFREY N. FREDMAN, JACQUELINE T. HARLOW, and
RYAN H. FLAX, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a
probiotic microbe composition. The Examiner rejected the claims on the
grounds of double patenting and as failing to comply with the written
description requirement. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.
1 Appellants identify the Real Party in Interest as Imagilin Technology (see
App. Br. 1).
Appeal2014-006330
Application 13/608,557
Statement of the Case
Background
"Probiotics are widely applied as nutritional supplements in animals
and humans" (Spec. i-f 4). "In order to have the maximum effects of
probiotics on animals and humans, one has to administrate live bacteria to
reach gastrointestinal tracts for multiplication" (Spec. i-f 5). "It is difficult to
maintain the viability of Lactobacillus and Bifidobacterium at room
temperature under consistent open and closure operations. Therefore,
variable results are often described" (Id.). "Recently, microencapsulation of
probiotics using lipids as the carriers has demonstrated the success for
improving the probiotics viability" (Spec. i-f 44).
The Specification teaches that the "microencapsulation using
biopolymers greatly enhance the benefit of probiotics as healthful
ingredients by retaining sufficient viability and bioactivity under harsh
processing conditions during animal feed and pet food production" (Spec.
,-r 45).
The Claims
Claims 1--4 are on appeal. Independent claim 1 is representative and
reads as follows:
1. A probiotic microbe composition comprising: at least one
probiotic microorganism comprising Pediococcus acidilactici
encapsulated in a single gelatin capsule, wherein the at least one
pro biotic microorganism comprises greater than 1x109 colony forming
units of Pediococcus acidilactici bacteria viable for greater than two
weeks, and further wherein said probiotic microbe composition
contains substantially no edible oil having prebiotic properties.
2
Appeal2014-006330
Application 13/608,557
The Issues2
A. The Examiner rejected claims 1--4 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement
(Ans. 6).
B. The Examiner rejected claims 1--4 on the ground of nonstatutory
double patenting over claims 1, 8, and 10 of U.S. Patent No. US 8,496,923
B2 (issued July 30, 2013) (Ans. 4).
C. The Examiner rejected claims 1 and 3 on the ground of nonstatutory
obviousness-type double patenting over claims 1 and 7 of copending
Application No. 12/806,392 (now issued as US Patent No. US 9,364,507 B2,
issued June 14, 2016) (Ans. 4--5).
D. The Examiner rejected claim 1 on the ground of nonstatutory
obviousness-type double patenting as being unpatentable over claim 1 of
U.S. Patent No. US 8,318,152 B2 (issued Nov. 27, 2012) (Ans. 5).
A. 35 U.S.C. § 112, written description
The issue with respect to this rejection is: Does the evidence of record
support the Examiner's conclusion that the negative limitation "wherein said
probiotic microbe composition contains substantially no edible oil having
prebiotic properties" lacks descriptive support in the Specification?
Findings of Fact
1. The Specification teaches "[r]ecently, microencapsulation of
probiotics using lipids as the carriers has demonstrated the success for
2 Because US 11/177 ,264 is abandoned, the provisional obviousness type
double patenting rejection is moot.
3
Appeal2014-006330
Application 13/608,557
improving the probiotics viability (Pacifico et al., 2001 ). However, there is
relatively little information and progress on microencapsulation of
probiotics, especially using biopolymers as the_microcarriers [sic]" (Spec.
ii 44).
2. The Specification teaches:
Microencapsulation, extensively used by pharmaceutical, chemical,
and food industries to protect precious and/or active ingredients and
ensure proper delivery, is limited to the techniques used (emulsion
and extrusion) and the composition of microcarriers, including Na-
alginate (also in combination with starch, pectin or whey proteins),
gum Arabic (also known as gum acacia), and K-carrageenan (also in
combination with locust bean gum).
(Spec. ii 45.)
3. The Specification teaches that a black Labrador hybrid was
"daily fed a piece of cheese wrapped with a capsule ofMITOMAXâ„¢, which
contains 4 billions CPU of Pediococcus acidilactici" (Spec. ii 56).
4. The Specification teaches that "Chesapeake Bay Retriever dogs
aged from 1 to 13 years with different chronic digestive disorders were
treated daily by mixing one MITOMAXâ„¢ capsule with the morning feeding
for 28 days" (Spec. ii 57).
5. The Specification teaches that "[d]ay-old broiler chicks were
housed in brooders at 15-20 birds per group and fed either control, only
commercial feed, or Pediococcus acidilactici containing commercial feed
from day one" (Spec. ii 70).
4
Appeal2014-006330
Application 13/608,557
Principles of Law
"Negative claim limitations are adequately supported when the
specification describes a reason to exclude the relevant limitation. Such
written description support need not rise to the level of disclaimer."
Santarus, Inc. v. Par Pharmaceutical, Inc., 694 F.3d 1344, 1351 (Fed. Cir.
2012).
Analysis
The Examiner finds that the "newly added claim terminology, 'and
further wherein said probiotic microbe composition contains substantially no
edible oil having pre biotic properties', is not supported or mentioned
anywhere in the specification or originally filed disclosure" (Ans. 6).
Appellants contend "[ w ]hile it is true that any negative limitation or
exclusionary proviso must have basis in the original disclosure, the mere
lack of literal basis in the specification for a negative limitation is not be
[sic] sufficient, standing alone to establish a prim a facie case for lack of
descriptive support" (App. Br. 6). Appellants also contend "when the
requirements of 35 USC 112 are satisfied, there is no real reason to reject a
claim which includes a negative limitation" (App. Br. 6).
We find that the Examiner has the better position. Appellants do not
identify, and we do not find, any basis in the Specification demonstrating
possession of the negative limitation "wherein said pro biotic microbe
composition contains substantially no edible oil having prebiotic properties"
in claim 1. While we recognize that the test is not an ipsis verbis test, the
negative limitation does not appear as an original claim limitation and the
word "oil" does not even appear in the Specification. Further, consistent
5
Appeal2014-006330
Application 13/608,557
with Santarus, Appellants do not identify a reason in the Specification to
exclude "edible oil" from the probiotic microbe composition.
Bimeda addressed a claim for controlling infection with "an
acriflavine free" formulation that was rejected as lacking descriptive support
because the original Specification did not mention "acriflavine." In re
Bimeda Research & Dev. Ltd., 724 F.3d 1320, 1323 (Fed. Cir. 2013). The
applicant in Bimeda relied upon an exemplary embodiment that lacked
acriflavine, but did not exclude other anti-infectives, and Bimeda found that
the "the patent's disclosure does not convey possession of the literal scope
of claim 32." Id. at 1323-1324.
Applying Bimeda and Santarus to the instant facts, the Specification
recognizes that lipids may be used as carriers (FF 1 ), but provides no reason
to exclude lipids themselves, much less any edible oil. While the
Specification provides alternative microencapsulation materials that do not
appear to comprise edible oils (FF 2), the Specification still lacks any reason
to exclude edible oils. Indeed, at least three of the Specification's own
examples combine the probiotic microbe composition with food including
cheese (FF 3), morning feeding (FF 4) or commercial feed (FF 5) that may
reasonably be understood to comprise edible oils.
Appellants identify no basis in the Specification or original claims to
demonstrate possession of a microbe composition open to any additional
component based on the "comprising" language but specifically excluding
"edible oil having prebiotic properties" as recited in claim 1.
6
Appeal2014-006330
Application 13/608,557
Conclusion of Law
The evidence of record supports the Examiner's conclusion that the
negative limitation "wherein said probiotic microbe composition contains
substantially no edible oil having prebiotic properties" lacks descriptive
support in the Specification.
B-D. Obviousness-Type Double Patenting
We summarily affirm the obviousness-type double patenting
rejections. See Manual of Patent Examining Procedure§ 1205.02 ("If a
ground of rejection stated by the examiner is not addressed in the appellant's
brief, that ground of rejection will be summarily sustained by the Board.")
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C. § 112,
first paragraph, as failing to comply with the written description
requirement. Claims 2--4 fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
We affirm the rejection of claims 1--4 on the ground of nonstatutory
double patenting over claims 1, 8, and 10 of U.S. Patent No. 8,496,923.
We affirm the rejection of claims 1 and 3 on the ground of
nonstatutory obviousness-type double patenting over claims 1 and 7 of
copending Application No. 12/806,392 (now issued as US Patent No.
9,364,507).
We affirm the rejection of claim 1 on the ground of nonstatutory
obviousness-type double patenting over claim 1 of U.S. Patent No.
8,318,152.
7
Appeal2014-006330
Application 13/608,557
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
8