Ex Parte Aurich-Costa et al

Patent Trial and Appeal Board

Sep 21, 2017

14531414 (P.T.A.B. Sep. 21, 2017)

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.
14/531,414 11/03/2014 Joan Aurich-Costa 4373.1005-003 1003
21005 7590 09/25/2017
HAMILTON, BROOK, SMITH & REYNOLDS, P.C.
530 VIRGINIA ROAD
P.O. BOX 9133
CONCORD, MA 01742-9133
EXAMINER
LU, FRANK WEI MIN
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
09/25/2017 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.department @hbsr.com
helpdesk@hbsr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOAN AURICH-COSTA,
ELIZABETH EWEN,
and MICHAEL GILDEA1
Appeal 2017-003250
Application 14/531,414
Technology Center 1600
Before DEMETRA J. MILLS, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify Cellay, Inc., as the real party in interest. App. Br. 3.
Appeal 2017-003250
Application 14/531,414
STATEMENT OF CASE
According to the Specification
In situ hybridization methods are widely used in the screening
and testing of patients for medical conditions, particularly cancer.
Successful in situ hybridization procedures depend, in part, on using
hybridization probes at an appropriate, precisely measured
concentration. Inaccurate results, including patient misdiagnoses,
frequently occur when hybridization probes are used at an
inappropriately high or low concentration.
Standard in situ hybridization procedures typically involve the
preparation of a hybridization solution having a desired concentration
of probe. To accomplish this, a precise amount of probe from a stock
solution is measured and added to a particular volume of hybridization
buffer using a micropipette. Errors in micropipetting, therefore, can
result in hybridization solutions having suboptimal concentrations of
probes, leading to high levels of background signal when probe
concentrations are too high or insufficiently detectable signals when
probe concentrations are too low.
Accordingly, there is a need to develop simplified and reliable in
situ hybridization procedures that do not require the use of
micropipettes to measure precise amounts of probe for the preparation
of hybridization solutions having specific probe concentrations.
Spec. 1-2. The claimed invention solves this problem.
Claims 1—11 are on appeal. The following claim is
representative.
1. A kit for detecting a target nucleic acid in a sample,
comprising:
a) a dry fibrous matrix comprising labeled nucleic acid probes
for detecting the target nucleic acid, wherein the labeled nucleic
acid probes are embedded in or sorbed to the matrix, and
comprise nucleotide sequences that are substantially
complementary to one or more nucleotide sequences in the
target nucleic acid, and wherein the dry fibrous matrix does not
2
Appeal 2017-003250
Application 14/531,414
dissolve upon exposure to a hydration buffer that releases the
probes from the matrix;
b) a hydration buffer for releasing the probes from the matrix.
Cited References
Bugawan US 2004/0126794 Al July 1,2004
Yang US 7,166,451 B1 Jan. 23, 2007
Bastian US 2007/0059747 Al Mar. 15,2007
Yoshinaga US 2007 /0178444 Al Aug. 2, 2007
Muller US 2008/0176209 Al July 24, 2008
Aurich-Costa US 2009/0215643 Al Aug. 27, 2009
Cooney US 2013/0078619 Al Mar. 28, 2013
Stratagene 1988 catalog
Youngmin Choi et al., Characteristics of Water-Soluble Fiber
Manufactured From Carboxymethylcellulose Synthesis, Korean J.
Chem. Eng. Vol. 24(2), 288-293 (2007) (“Choi”)
Grounds of Rejection
1. Claims 1^4 and 7 are rejected under pre-AIA 35 U.S.C. § 103(a) as
being unpatentable over Muller in view of Bugawan and 1988
Stratagene catalog.
2. Claim 5 is rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Muller, Bugawan, 1988 Stratagene catalog, and
Aurich-Costa.
3. Claim 6 is rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Muller, Bugawan, 1988 Stratagene catalog, and
Cooney.
3
Appeal 2017-003250
Application 14/531,414
4. Claims 8 and 9 are rejected under pre-AIA 35 U.S.C. § 103(a) as
being unpatentable over Muller, Bugawan, 1988 Stratagene catalog,
and Yoshinaga.
5. Claim 10 is rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Muller, Bugawan, 1988 Stratagene catalog, and
Yang.
6. Claim 11 is rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Muller, Bugawan, 1988 Stratagene catalog, and
Bastian.
FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Final Action at
pages 4—10. The following facts are highlighted.
1. The Specification discloses,
According to the invention, the biological sample is
contacted with a dry fibrous matrix containing nucleic acid
probes. The dry fibrous matrix can be composed of a naturally-
occurring fiber or a synthetic fiber. The fiber can be a woven
fiber or a nonwoven fiber. Exemplary fibers include, but are
not limited to, glass fibers, wool fibers, and plant fibers. In a
preferred embodiment, the fiber is a glass fiber. In another
embodiment, the fibrous matrix comprises a cellulose-based
material (e.g., a cellulose fiber). Suitable cellulose-based
materials include, but are not limited to, cellulose,
nitrocellulose, carboxymethylcellulose, rayon, and viscose.
In a particular embodiment, the dry fibrous matrix is a
filter paper (e.g., a cellulose-based filter paper, a glass fiber
filter paper). Suitable filter papers are available commercially,
including, for example, Whatman™ cellulose and glass
microfiber filter papers (GE Healthcare).
Spec. 11 (emphasis added).
4
Appeal 2017-003250
Application 14/531,414
2. Muller discloses,
Certain embodiments of the present invention are
contemplated that expressly exclude dissolvable or
dissociatable matrix materials such as soluble cationic
polymers (e.g., DEAE-dextran) or anionic polymers (e.g.,
dextran sulphate) or agarose when used, absent other
components of the herein described embodiments, with a di- or
trisaccharide stabilizer (e.g., trehalose, lactitol, lactose, maltose,
maltitol, sucrose, sorbitol, cellobiose, inositol, or chitosan) as
disclosed for dry protein storage ....
1147 (emphasis added).
3. Muller also discloses,
Similarly, as another example, the matrix material may
dissociate in a solvent and may, but need not, become fully
solubilized, such that a dispersion, suspension, colloid, gel, sap,
slurry, syrup, or the like may be obtained. In other
embodiments a matrix material may include one or more
components such as, but not limited to, a sponge-like material,
silica, silica powder, silica filter paper, absorbent powder,
cotton, wool, linen, polyester or filter paper, any of which may
influence physicochemical properties, including solubility
properties, of the storage matrix, as will be appreciated by those
familiar with the art.
1137 (emphasis added).
4. Muller discloses,
As described herein, a matrix for substantially dry storage of
a biological sample may, according to certain embodiments,. . .
the matrix material comprises one or more of
polyvinylpyrrolidone (PVP), carboxymethylcellulose (CMC), 2-
hydroxyethylcellulose, poly(2-ethyl-2-oxazoline) and the like,
or another matrix material as described herein.
1144 (emphasis added).
5
Appeal 2017-003250
Application 14/531,414
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Obviousness Rejection — Muller, Bugawan and Stratagene
The Examiner finds that
Muller et al., teach a dry fibrous matrix comprising nucleic acid
probes (eg., dry matrix material such as cotton or polyester
containing oligonucleotides or cDNA or PCR products) for
detecting the target nucleic acid, wherein the nucleic acid
probes are embedded in or sorbed to the matrix, and comprise
nucleotide sequences that are substantially complementary to
one or more nucleotide sequences in the target nucleic acid,
wherein the dry fibrous matrix does not dissolve upon exposure
to a hydration buffer that releases the probes from the matrix;
and a hydration buffer for releasing the probes from the matrix
as recited in claim 1 wherein the fibrous matrix comprises a
glass fiber, a wool fiber, a synthetic fiber (eg., polyester) or a
plant fiber (cotton as recited in claim 2, the fibrous matrix
comprises a cellulose based material (eg., a natural cellulose
fiber such as cotton or a manufactured cellulose fiber such as
polyester) as recited in claim 3, one or more additional reagents
selected from the group consisting of salmon sperm DNA, a
blocking reagent and an antimicrobial agent (ie., a stabilizer
comprising an antimicrobial agent), or a combination thereof
are embedded in or sorbed to the matrix as recited in claim 4
(see page 3, paragraphs [0017] and [0018], page 4, paragraphs
[0025] and [0026], page 5, paragraph [0028], pages 21 and 22,
6
Appeal 2017-003250
Application 14/531,414
paragraphs [137] and [0138], page 25, paragraph [0175], and
page 33, paragraph [0214]).
Final Act 4—5.
The Examiner acknowledges,
Muller et al., do not disclose a kit comprising a dry
fibrous matrix comprising labeled nucleic acid probes as recited
in claim 1 wherein the labeled nucleic acid probes are synthetic
DNA oligonucleotide probes as recited in claim 7. However,
Muller et al., teach a dry fibrous matrix comprising nucleic acid
probes as recited in claim 1 wherein the nucleic acid probes are
synthetic DNA oligonucleotide probes as recited in claim 7
(eg., page 42, paragraph [0301]) and a kit comprising (I) a
biological sample storage device for one or a plurality of
biological samples, comprising (a) a lid; (b) a sample plate
comprising one or a plurality of sample wells that are capable
of containing a biological sample, wherein one or more of said
wells comprises a matrix material; and (c) at least one radio
frequency transponder device; and (II) one or more ancillary
reagents (see pages 12 and 13, paragraph [0071]).
Final Act 5.
The Examiner also finds Bugawan “teach[es] to immobilize a labeled
polynucleotide on a membrane (e.g., a matrix) wherein the label on the
labeled polynucleotide is a fluorescent dye” (Final Act. 6 (citing Bugawan
11 64, 99-100, 106)), and that “1988 Stratagene catalog teaches a motivation
to combine reagents into kit format (page 39).” Id.
The Examiner concludes that
it would have been prima facie obvious to one having ordinary
skill in the art at the time the invention was made to have made
the kits as recited in claims 1 and 7 using labeled nucleic acid
probes wherein the labeled nucleic acid probes are synthetic
DNA oligonucleotide probes in view of the prior arts of Muller
et al., Bagawan et al., and 1988 Stratagene. One having
ordinary skill in the art would have been motivated to do so
7
Appeal 2017-003250
Application 14/531,414
because Bagawan et al., have successfully immobilized a
labeled polynucleotide on a membrane (eg., a matrix) wherein
the label on the labeled polynucleotide is a fluorescent dye (see
page 4, paragraph [0064] and pages 7 and 8, paragraphs [0099],
[0100] and [0106]) while the Stratagene catalog teaches a
motivation for combining reagents of use in an assay into a
kit... .
Final Act. 6.
Appellants contend that “Muller does not teach or suggest using a dry
fibrous matrix that does not dissolve upon exposure to a hydration buffer, as
recited in Claim 1. In fact, as discussed below, Muller teaches just the
opposite.” App. Br. 5. Appellants further argue that,
Appellant further pointed out that the cited secondary
references Bagawan and Stratagene do not provide a suggestion
or motivation to modify the dissolvable/dissociable matrices of
Muller to render these matrices resistant to dissolution upon
hydration. In fact, as Appellant explained, modifying the
dissolvable/dissociable matrices of Muller in the manner
articulated by the Examiner would render them unsuitable for
their intended purpose of dissolving under rehydration
conditions to allow recovery of biological material that has
been stored on the matrices (See, e.g., abstract, and paragraph
[0011] of Muller), thereby rendering the rejection legally
improper.
App. Br. 6.
ANALYSIS
Appellants do not argue rejections 2—6 separately in the Brief. Nor do
Appellants argue individual claims separately. We select claim 1 as
representative claim for all rejections. The dispositive issue in the case is
whether the pending claims are obvious in view of Muller, Bugawan, and
Stratagene. We agree with the Examiner’s fact finding, statement of the
8
Appeal 2017-003250
Application 14/531,414
rejection, and responses to Appellants’ arguments as set forth in the Answer.
We find that the Examiner has provided evidence to support a prima facie
case of obviousness. We provide the following additional comment to the
Examiner’s argument set forth in the Final Rejection and Answer.
We are not persuaded by Appellants’ arguments that Muller only
teaches the use of dissolvable or dissociative fibrous materials and does not
teach dry fibrous matrix that does not dissolve upon exposure to a hydration,
as claimed. App. Br. 5.
Muller discloses fibrous matrices for use as supports of biological
samples such as nucleic acids and cells. Abstract. Muller specifically
discloses the use of wool, glass (silica) fibrous material and
carboxymethylcellulose fibrous material for the matrices. FF. 3, 4.
Appellants’ Specification also contemplates wool, glass (silica) fibrous
material and carboxymethylcellulose fibrous material. FF. 1. Furthermore,
Muller specifically states that “[cjertain embodiments of the present
invention are contemplated that expressly exclude dissolvable or dissociable
matrix materials.” FF. 2, 3. Although Muller primarily discusses the use of
dissolvable matrices in its disclosed methods, Muller also discloses the use
of non-dissolvable matrices to the exclusion of dissolvable or dissociatable
matrix materials. FF 2, 3 (“Certain embodiments of the present invention are
contemplated that expressly exclude dissolvable or dissociatable matrix
materials”). When dissolvable and dissociable matrixes are excluded from
the matrices, one is necessarily left with only non-dissolvable and non-
dissociable matrices. These embodiments are also contemplated by Muller.
Appellants present no further arguments in the Appeal Brief.
Appellants do not put forth arguments with respect to rejections 2-6 in the
9
Appeal 2017-003250
Application 14/531,414
Brief. Because Muller specifically discloses dry, fibrous materials which
exclude dissolvable or dissociable matrix materials (FF. 2, 3) we affirm
obviousness rejections 1—6.
CONCLUSION OF LAW
The cited references support the Examiner’s obviousness rejections 1—
6, which are affirmed for the reasons of record. All pending, rejected claims
fall.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
10