Ex Parte Belenky et al

Board of Patent Appeals and Interferences

Mar 1, 2011

11089261 (B.P.A.I. Mar. 1, 2011)

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.
11/089,261 03/24/2005 Alexander Belenky BYR-84 (MST-2432) 8134
28524 7590 03/01/2011
SIEMENS CORPORATION
INTELLECTUAL PROPERTY DEPARTMENT
170 WOOD AVENUE SOUTH
ISELIN, NJ 08830
EXAMINER
FOSTER, CHRISTINE E
ART UNIT PAPER NUMBER
1641
MAIL DATE DELIVERY MODE
03/01/2011 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ALEXANDER BELENKY,
LAURIE ANN LIVSHIN, and MINAS BARBARAKIS
__________

Appeal 2010-007512
Application 11/089,261
Technology Center 1600
__________

Before DONALD E. ADAMS, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, and Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to a reagent
composition. The Examiner has rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
Appeal 2010-007512
Application 11/089,261

2
STATEMENT OF THE CASE
Claims 5 and 21 are on appeal (App. Br. 3).2 The claims have not
been argued separately and therefore stand or fall together. 37 C.F.R.
§ 41.37(c)(1)(vii). We will focus on claim 21, the only independent claim
on appeal, which reads as follows:
21. An automated immunoanalyzer reagent composition adapted to
extract cyclosporine analyte from a heterogeneous biological test sample
selected from the group consisting of serum, plasma, whole blood, urine, and
spinal fluid; in the absence of an organic solvent, in the absence of a
precipitating agent, and without separation of the cyclosporine from the test
sample, comprising an aqueous solution of:
(a) about 0.25 weight % to about 0.5 weight % of a zwitterionic
detergent selected from the group consisting of:
3-[N, N-dimethyl(3-myristoylaminopropyl)ammonio]-propanesulfate,
3-(4-heptyl)phenyl 3-hydroxy propyl)dimethylammonio propane sulfate,
3-(decyldimethylammonio)propanesulfonate inner salt,
3-(N, N-dimethylmyristylammonio)propanesulfonate,
3-(N, N-dimethyloctadecylammonio)propanesulfonate,
3-(N, N-dimethyloctylammonio)propanesulfonate inner salt,
3-(N, N-dimethylpalmitylammonio)propanesulfonate, and
3-(dodecyldimethylammonio)propanesulfonate inner salt;
(b) about 0.25 weight % to about 0.5 weight % of saponin; and
(c) about 5 weight % to about 50 weight % of a viscosity additive
selected from the group consisting of glycerin and sucrose.

2 Claims 11-20 are also pending but have been withdrawn from
consideration (App. Br. 3).
Appeal 2010-007512
Application 11/089,261

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Claims 5 and 21 stand rejected under 35 U.S.C. § 103(a) as obvious
over Zeggari3 in view of VandenBerg,4 Anilionis,5 or Schneider6 in light of
Sigma-Aldrich,7 EMD Biosciences,8 and Pitha9 (Ans. 5-6).
Claims 5 and 21 stand rejected under 35 U.S.C. § 103(a) as obvious
over Tajima10 in view of Hoiseth11 and Fang12 in light of Sigma-Aldrich 213
and Pitha (Ans. 9).
I
With regard to the obviousness rejection of claims 5 and 21 over
Zeggari in view of various references, we affirm this rejection for the
reasons set forth in the Examiner’s Answer. In particular, we conclude that
the Examiner has set forth a prima facie case that Zeggari, as combined with
other applied references, suggests a composition that is capable of being
used according to the recited intended use. See In re Zierden, 411 F.2d
1325, 1328 (CCPA 1969) (“[M]ere statement of a new use for an otherwise
old or obvious composition cannot render a claim to the composition

3 Zeggari et al., Solubilization and characterization of guinea-pig pancreatic
somatostatin receptors, 164 EUR. J. BIOCHEM. 667-673 (1987).
4 VandenBerg et al., Solubilization and characterization of high-affinity
[3H]serotonin binding sites from bovine cortical membranes, 80 PROC.
NATL. ACAD. SCI. USA 3508-3512 (1983).
5 Anilionis et al., US 5,098,997, Mar. 24, 1992.
6 Schneider et al., US 2007/0157326 A1, Jul. 5, 2007.
7 Sigma-Aldrich, product information for T7763.
8 EMD Biosciences, product information for Zwittergent® 3-14 Detergent.
9 Pitha, US 4,546,097, Oct. 8, 1985.
10 Tajima et al., US 7,045,593 B2, May 16, 2006.
11 Hoiseth et al., WO 2005/065708 A2, Jul. 21, 2005.
12 Fang et al., US 2005/0048648 A1, Mar. 3, 2005.
13 Sigma-Aldrich, product information for D4516.
Appeal 2010-007512
Application 11/089,261

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patentable.”). In addition, we agree with the Examiner that Appellants have
not provided sufficient evidence that the claimed composition provides
unexpectedly superior properties as compared to the closest prior art.
II
With regard to the obviousness rejection over Tajima in view of Fang,
as well as other references, the Examiner relies on Tajima for teaching “a
reagent (‘cell-free protein synthesis system’) comprising a mild detergent in
aqueous solution” and that “suitable detergents can be used as a single
species, or as a combination” (Ans. 10). The Examiner relies on Pitha and
Sigma-Aldrich 2 for providing evidence that one of Tajima’s detergents,
digitonin, is a saponin and that another of Tajima’s detergents,
N,N-dimethyldodecylammonio propanesulfonate, is one of the claimed
zwitterionic detergents, 3-(dodecyldimethylammonio)propanesulfonate (id.).
Regarding the amounts of detergents, the Examiner finds that Tajima
“teaches digitonin in amounts of 0.1-2%” (id. at 11). In addition, the
Examiner finds that Tajima generally “directs the skilled artisan to employ
amounts that are preferably 3 to 10 times the CMC of the detergent” (id.).
The Examiner relies on Hoiseth for teaching that the “CMC of 3-(dodecyl-
dimethylammonio)propanesulfonate . . . was known in the prior art to be
0.047%-0.13%” (id.). The Examiner concludes that “it would have been
further obvious when including 3-(dodecyldimethylammonio)propane-
sulfonate to employ this detergent in the claimed amounts because using 3 to
10 times the CMC as directed by Tajima . . . would give amounts of 0.14%-
1.3%” (id.).
Appeal 2010-007512
Application 11/089,261

5
The Examiner relies on Fang for teaching “membrane stabilizers that
can be used to stabilize arrays of membrane proteins [0045]” (Ans. 13). In
particular, the Examiner finds that Fang teaches “that about 10% glycerol
(glycerin) can be added in order to enhance the stability of membrane-
embedded receptor arrays” (id.). The Examiner concludes that “it would
have been further obvious to include glycerol in amounts falling within the
claimed range in the reagent of Tajima . . . and Hoiseth . . . because Fang . . .
taught that glycerol also acts to stabilize membrane proteins, which is the
same purpose for which the reagent of Tajima . . . is used” (id.).
Appellants argue that “the combination of Fang with [Tajima and
Hoiseth] would result in a collection of disparate teachings, without any
unifying theme, that would not collectively suggest Applicants’ claimed
invention in an obvious manner” (App. Br. 10).
Issue
Has the Examiner set forth a prima facie case that it would have been
obvious, based on the disclosures in Fang, to include glycerol (or sucrose) in
a composition according to Tajima that comprises the claimed amounts of a
zwitterionic detergent and a saponin?
Findings of Fact
1. Tajima discloses a “method for producing a protein using a
cell-free protein synthesis system comprising a detergent so that the protein
can be synthesized without aggregation” (Tajima, Abstract).
2. Tajima also discloses that the “protein is a protein comprising a
hydrophobic region in at least a portion thereof, for example, a membrane
protein or its fragment” (id.).
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Application 11/089,261

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3. In addition, Tajima discloses that the “synthesized protein is
found to have biological functions with great probability, even though it is
not in the native states in vivo, such as a membrane bound state” (id. at
col. 2, ll. 25-27).
4. Tajima also discloses: “It is further preferable to reconstitute
the protein synthesized in the cell-free protein synthesis system with
artificial membranes, liposomes or the like. . . . The synthesized protein is
reconstituted in a lipid membrane by decreasing the concentration of
detergent . . . in a cell-free protein synthesis system supplemented with the
detergent and lipid.” (Id. at col. 7, ll. 58-67.)
5. Fang discloses a “buffered solution or ‘ink’ composition for re-
formulating or suspending biological membranes used in the fabrication of
membrane arrays,” the composition comprising “at least two of the
following six classes of reagents: 1) a pH buffer reagent; 2) a monovalent or
divalent, inorganic salt; 3) a membrane stabilizer; 4) a solution viscosity
control reagent; 5) a water-soluble protein; or, 6) a protease inhibitor” (Fang,
Abstract).
6. Fang also discloses:
The membrane stabilizer is preferably either trehalose or
sucrose. Glycerol or the like also can be included so as to
achieve better viscosity in the receptor solution for sample pick-
up and deposition by a pin. . . . Most preferably, the receptor
membrane preparations are re-suspended in a buffer containing:
50 m/M Tris-HCl, pH 7.4, 10 mM MgCl2, 0.5% BSA, ~10%
trehalose or sucrose, and ~10% glycerol.
(Id. at ¶ [0045].)
Appeal 2010-007512
Application 11/089,261

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Principles of Law
A claim “composed of several elements is not proved obvious merely
by demonstrating that each of its elements was, independently, known in the
prior art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). The
relevant question is “whether there was an apparent reason to combine the
known elements in the fashion claimed by the patent at issue.” Id.
Analysis
Tajima discloses a composition comprising a detergent that can be
used for synthesizing a membrane protein (Findings of Fact (FF) 1-2). Fang
discloses a “buffered solution or ‘ink’ composition for re-formulating or
suspending biological membranes” (FF 5).
Fang discloses adding glycerol “to achieve better viscosity” (FF 6).
However, the Examiner has not adequately explained why one of ordinary
skill in the art would have added a viscosity additive to Tajima’s detergent
composition.
Fang also discloses adding sucrose as a membrane stabilizer (FF 6).
However, the Examiner has not adequately explained why one of ordinary
skill in the art would have added a membrane stabilizer to Tajima’s
detergent composition. The Examiner finds that, “as both Tajima et al. and
Fang are directed to the problems of stabilizing hydrophobic analytes (and
specifically, membrane proteins), . . . the prior art inventions do share in
common this unifying theme” (Ans. 26). However, whereas Tajima teaches
using its detergent composition in the synthesis of a membrane protein that
is not membrane bound (FF 1-3), Fang discloses including sucrose to
stabilize the membrane itself (FF 6). Therefore, we do not agree with the
Appeal 2010-007512
Application 11/089,261

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Examiner’s conclusion that the detergents of Tajima and the membrane
stabilizers of Fang are directed to the same purpose. In addition, although
Tajima does disclose reconstituting the synthesized protein with a membrane
(FF 4), the Examiner has not shown that it would have been obvious to
include the claimed amounts of detergents during the reconstitution.
Conclusion
The Examiner has not set forth a prima facie case that it would have
been obvious, based on the disclosures in Fang, to include glycerol (or
sucrose) in a composition according to Tajima that comprises the claimed
amounts of a zwitterionic detergent and a saponin. We therefore reverse the
obviousness rejection of claims 5 and 21 over Tajima in view of Fang, as
well as other references.
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

cdc

SIEMENS CORPORATION
INTELLECTUAL PROPERTY DEPARTMENT
170 WOOD AVENUE SOUTH
ISELIN, NJ 08830