Ex Parte Aehle et al

Patent Trial and Appeal Board

Mar 30, 2016

12443255 (P.T.A.B. Mar. 30, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/443,255 05/25/2010
5100 7590 04/01/2016
DANISCO US INC
ATTENTION: LEGAL DEPARTMENT
925 PAGE MILL ROAD
PALO ALTO, CA 94304
FIRST NAMED INVENTOR
Wolfgang Aehle
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.
30927US 7583
EXAMINER
PAK, YONGD
ART UNIT PAPER NUMBER
1652
NOTIFICATION DATE DELIVERY MODE
04/01/2016 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):
PTO-Legal.PRC@dupont.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WOLFGANG AEHLE, PIET VAN SOLINGEN,
MAR TIN S. SCHEFFERS, and RICHARD R. BOTT1
Appeal2014-000925
Application 12/443,255
Technology Center 1600
Before JEFFREY N. FREDMAN, TINA E. HULSE, and
RICHARD J. SMITH, Administrative Patent Judges.
HULSE, Administrative Patent Judge
I. DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims relating to
an isolated glucoamylase variant with altered properties, such as improved
thermostability and/or specific activity. The Examiner rejected the claims as
obvious and under the doctrine of obviousness-type double patenting. We
have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
1 Appellants identify the real party-in-interest as Danisco US Inc. (Br. 2.)
Appeal2014-000925
Application 12/443,255
IL STATEMENT OF THE CASE
The claimed invention relates to "variants of a parent glucoamylase
having altered properties (e.g., improved thermostability and/or specific
activity)." (Spec. i-f 2.) According to the Specification, "[a]lthough
glucoamylases have been used successfully in commercial applications for
many years, a need still exists for new glucoamylases with altered
properties, such as improved specific activity and increased thermostability."
(Id. i-f 6.)
Claims 27-29, 31, and 32 are on appeal. (Br. 2.)
Claim 27, the only independent claim, is illustrative and is reproduced
below:
27. An isolated glucoamylase variant comprising an amino
acid sequence having at least 90% sequence identity to SEQ ID
NO: 2, wherein said variant includes at least a substitution
selected from I43R/F/D/Y/S compared to the amino acid
sequence of SEQ ID NO: 2.
Claims 27-29, 31, and 32 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Nielsen2 and Dunn-Coleman.3 (Ans. 4---6.)
Claims 27-29, 31, and 32 also stand rejected under the doctrine of
obviousness-type double patenting over claims 1-16 of US 8,058,033 B2.
(Id. at 6-7.)
III. DISCUSSION
A. Rejection Under 35 U.S.C. § 103 over Nielsen and Dunn-Coleman
The Examiner rejected claims 27-29, 31, and 32 as unpatentable over
the combination of Nielsen and Dunn-Coleman. (Ans. 4--6.) Nielsen relates
2 Nielsen et al., US 6,352,851 Bl, issued Mar. 5, 2002.
3 Dunn-Coleman et al., US 7,494,685 B2, issued Feb. 24, 2009.
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Appeal2014-000925
Application 12/443,255
to a variant of a parent fungal glucoamylase that exhibits improved thermal
stability and/or increased specific activity using saccharide substrates.
(Nielsen, Abstract.) Nielsen identifies various regions of interest in the
amino acid sequence disclosed as SEQ ID NO: 2 for increasing specific
activity and/or improved thermostability, including region 40-62, or in a
corresponding position or region in a homologous glucoamylase that
displays at least 60% homology with SEQ ID NO: 2. (Id. at 4:29-36, 5:22-
43.) Nielsen also specifically identifies T43R, among numerous others, as a
specific preferred mutation. (Id. at 6:23.)
The Examiner states that Nielsen discloses mutating the amino acid
corresponding to position 43 of a parent glucoamylase with an arginine
residue, "which corresponds to the amino acid I43 of SEQ ID N0:2 of the
instant invention." (Final Act. 4.) According to the Examiner, the
difference between Nielsen and the claimed invention is that Nielsen does
not disclose mutating a Trichoderma reesei glucoamylase of SEQ ID NO: 2.
(Id.) The Examiner then states that the teaching of Nielsen can be applied to
other fungal glucoamylases, like that disclosed in Dunn-Coleman, which has
100% sequence identity to SEQ ID N0:2 of the claimed invention. (Id. at
4-5). The Examiner concludes that it would have been obvious to substitute
the amino acid at position 43 with an arginine residue in the glucoamylase of
Dunn-Coleman because a person of ordinary skill in the art would have been
motivated to make improved properties of the glucoamylase through site
specification mutagenesis, which is a well-known technique. (Id. at 5.)
Appellants argue that the T43 site in Nielsen does not correspond to
the I43 site in SEQ ID NO: 2 of the claimed invention. (App. Br. 5.)
Rather, Appellants assert that position D44 of the glucoamylase of Nielsen
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Application 12/443,255
corresponds to 143 of SEQ ID NO: 2 of the instant application. (Id.) As
support, Appellants submit the sequence alignment of the relevant region
provided by the Examiner, reproduced below:
t
Accordingly, Appellants argue that the disclosure of T43R in Nielsen is not
directly relevant to the I43 substitutions claimed. (Id.)
The Examiner further asserts, however, that the rejection does not
assert that T43 of the glucoamylase in Nielsen corresponds to I43 of SEQ ID
NO: 2 of the claimed invention. (Ans. 8.) Rather, the Examiner states that
Nielsen also discloses "mutating other residues of a glucoamylase, such as
the residue corresponding to 143 of SEQ ID N0:2 of the instant invention,
D44, in order to increase thermostability and specific acitivity." (Id., citing
Nielsen, 4:29-36, 5:29.) The Examiner also states that Nielsen identifies
regions of glucoamylase suitable for mutation in improving thermostability
and/or increased specific activity. (Id. at 9.) The Examiner found that it
would have been obvious to one of ordinary skill in the art to make
substitutions at residues corresponding to positions 40-62 of Nielsen,
including I43 of SEQ ID NO: 2, "since there are only a finite number of
amino acid substitutions to be made at positions 40-62." (Id. at 9-10.)
We are not persuaded that a preponderance of the evidence supports
the Examiner's rejection. As Appellants argue, and the Examiner concedes,
Nielsen's disclosure of the specific T43R mutation does not correspond to
I43R of SEQ ID N0:2. (Ans. 8.) Although the Examiner relies on Nielsen's
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Application 12/443,255
disclosure of region 40-62 of Nielsen as being only a "finite number" of
potential substitutions (Ans. 9-10), we agree with Appellants that Nielsen's
disclosure of the "40-62 region" is insufficient to teach the claimed
substitution at position I43 of SEQ ID N0:2 (App. Br. 6-8). As Appellants
note, Nielsen characterizes numerous glucoamylase variants from column 5,
line 20 to column 10, line 32. (App. Br. 6.) Moreover, we note that in
relying on region 40-62, the Examiner ignores at least twelve other regions
of glucoamylase variants disclosed in Nielsen. (See, e.g., Nielsen, 5 :20-40)
(identifying thirteen different regions of glucoamylase variants).
We find that the Examiner fails to explain why a person of ordinary
skill in the art would have had a reason to modify position I43 of SEQ ID
N0:2 of the claimed invention over the many other mutations disclosed in
Nielsen, not only in region 40-62, but in other regions, as well. Specifically,
we are not persuaded that the Examiner has shown that a person of ordinary
skill in the art would have chosen to mutate position I43 of SEQ ID N0:2-
as opposed to the many other preferred specific mutations disclosed in
Nielsen-without the guidance of impermissible hindsight. As the Federal
Circuit has explained, "[ c ]are must be taken to avoid hindsight
reconstruction by using 'the patent in suit as a guide through the maze of
prior art references, combining the right references in the right way so as to
achieve the result of the claims in suit."' In re NTP, Inc., 654 F.3d 1279,
1299 (Fed. Cir. 2011) (quoting Grain Processing Corp. v. Am.-Maize Prods.
Co., 840 F.2d 902, 907 (Fed. Cir. 1988)); see also Cheese Sys., Inc. v. Tetra
Pak Cheese and Powder Sys., Inc., 725 F.3d 1341, 1352 (Fed. Cir. 2013)
("Obviousness 'cannot be based on the hindsight combination of
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Application 12/443,255
components selectively culled from the prior art to fit the parameters of the
patented invention.'") (citation omitted).
Because the Examiner has failed to provide articulated reasoning with
some rational underpinning regarding why a person of ordinary skill in the
art reading Nielsen would have had a reason to modify position 143 of SEQ
ID N0:2 of Dunn-Coleman to reach the claimed invention, we reverse the
Examiner's rejection of claim 27 and its dependent claims 28, 29, 31, and 32
under§ 103. See In re Kahn, 441 F.3d 977, 988 ("[R]ejections on
obviousness grounds cannot be sustained by mere conclusory statements;
instead there must be some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness.").
B. Obviousness-Type Double Patenting Rejection
The Examiner rejected claims 27-29, 31, and 32 under the doctrine of
obviousness-type double patenting as being unpatentable over claims 1-16
of U.S. Patent No. 8,058,033. (Ans. 6-7.) Appellants did not respond
substantively to this rejection, stating only that they request that the rejection
be held in abeyance until patentable subject matter is identified in the
application. (Br. 10.)
Because Appellants have not responded substantively to the
obviousness-type double patenting rejection, Appellants have waived any
such argument. Accordingly, we affirm the Examiner's rejection of claims
27-29, 31, and32. SeeHyattv. Dudas, 551F.3d1307, 1314 (Fed. Cir.
2008).
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Application 12/443,255
IV. SUMMARY
We reverse the obviousness rejection of claims 27-29, 31, and 32
over Nielsen and Dunn-Coleman.
We affirm the obviousness-type double patenting rejection of claims
27-29, 31, and 32.
V. 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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