Ex Parte Biemans et al

Patent Trial and Appeal Board

Jul 29, 2016

12693271 (P.T.A.B. Jul. 29, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/693,271 01125/2010
23347 7590 08/02/2016
GLAXOSMITHKLINE
GLOBAL PATENTS
FIVE MOORE DR., PO BOX 13398
MAIL STOP: 5.5A
FIRST NAMED INVENTOR
Ralph Biemans
RESEARCH TRIANGLE PARK, NC 27709-3398
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.
VB60395ClUS 3721
EXAMINER
GANGLE, BRIAN J
ART UNIT PAPER NUMBER
1645
NOTIFICATION DATE DELIVERY MODE
08/02/2016 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):
USCIPRTP@GSK.COM
laura.m.mccullen@gsk.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RALPH BIEMANS, MARTINE BOS, PHILIPPE DENOEL,
CHRISTIANE FERON, CARINE GORAJ, JAN POOLMAN,
VINCENT WEYNANTS, and
JOHANNES PETRUS MARIA TOMMASSEN
Appeal2014-003289
Application 12/693,271
Technology Center 1600
Before DONALD E. ADAMS, ULRIKE W. JENKS, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL 1
This appeal under 35 U.S.C. § 134(a) involves claims 1, 3-11, and
12-17 (Supp. Br. 2). Examiner entered a rejection under 35 U.S.C. § 103(a).
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
Appellants disclose methods "of refolding N spA protein - an outer
membrane protein of Neisseria meningitides organisms" (Spec. 1: 11-12).
1 Appellants identify the Real Party in Interest as "GlaxoSmithKline
Biologicals SA" (Supp. Br. 1 ).
Appeal2014-003289
Application 12/693,271
Claim 1 is representative and reproduced below, with the exclusion of
optional method steps recited in the claim:
1. A method of preparing a medicament containing an isolated,
refolded NspA protein, said method comprising the step[] of: ...
( e) contacting a solubilized N spA protein with a refolding buffer
comprising 3-dimethy ldodecy lammoni opropanesulfonate ( S B-12).
Claims 1, 3-9, 12, and 13 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Jansen2 and Brodeur. 3
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. We adopt Examiner's findings concerning the scope and content of
the prior art (Ans. 2---6), and repeat the following for emphasis.
FF 2. Examiner relies upon Jansen to disclose refolding of PorA protein
from Neisseria meningitides by contacting the protein "with a buffer
containing SB-12 []and ethanolamine" (Ans. 2-3, citing Jansen 286: col. 1,
i-fi-12-3 and 289: col. 1 ).
FF 3. Jansen discloses that "[p]reviously, ... it was shown that Zwittergent
3-14 was a suitable detergent for refolding SDS-denatured PorA" (Jansen
288: 18-20; see generally Ans. 5).
2 Jansen et al., Biochemical and biophysical characterization of in vitro
folded outer membrane porin PorA of Neisseria meningitides, 1464
Biochimica et Biophysica Acta 284--298 (2000).
3 Brodeur et al., WO 96/29412, published Sept. 26, 1996.
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Application 12/693,271
FF 4. Jansen discloses that "[tlor large scale folding and purification,
[Jansen] chose, for economical reasons, the use of SB 12" (Jansen 289: col.
1, 11. 5---6; see generally Ans. 5).
FF 5. Examiner finds that Jansen "differs from [Appellants'] invention in
that [Jansen] folded PorA instead ofNspA" (Ans. 3)
FF 6. Appellants disclose that "NspA is[] described in [Brodeur]" (Spec.
17: 25; Ans. 3).
FF 7. Examiner finds that Brodeur obtained folded N spA protein by
"contacting the protein with Zwittergent 3, 14" (Ans. 3, citing Brodeur 64).
FF 8. Examiner finds that:
Burgess studied the ability of a set of proteins to insert and fold
into lipid bilayers. [Appellants'] claims do not involve proteins
that insert into lipid bilayers. Burgess looked at the effect of
various temperatures, lipid types, and bilayer thicknesses on
insertion and folding. None of [which is] relevant to
[Appellants'] claims.
(Ans. 5.)
ANALYSIS
Based on the combination of Jansen and Brodeur, Examiner concludes
that, at the time Appellants' invention was made, it would have been prima
facie obvious "to substitute neisserial NspA for neisserial PorA in the
folding method of Jansen" (Ans. 3). We agree.
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
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Appeal2014-003289
Application 12/693,271
instance the fact that a combination was obvious to try might
show that is was obvious under § 103.
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). On this record,
Examiner established that a person of ordinary skill in this art would fold
Neiseria gonorrhoeae proteins, such as PorA and NspA, by contacting a
solubilized NspA protein with a refolding buffer comprising SB12, because
SB12 is an economical substitute for Zwittergent 3, 14, which is known to
be useful in the folding ofNspA protein (FF 1-7).
For the foregoing reasons we are not persuaded by Appellants'
contention that the combination of Jansen and Brodeur "does not teach or
suggest that N spA protein can be refolded into its native conf[ o ]rmation in a
refolding buffer comprising [SB-12]" or provide a reasonable expectation of
successfully refolding NspA "protein having the activity of the native
protein" (Supp. Br. 4 and 5). In this regard, we note that Appellants' claim 1
does not "include any particular folding conditions other than to name the
buffer (SB-12r (Ans. 5). Appellants; claim 1 also does not require the
NspA protein to fold into a "native conformation" or into a conformation
that "ha[s] the activity of the native protein" (see Appellants' claim 1; cf
Supp. Br. 4 and 5). Further to the extent that Appellants would contend that
their claimed invention, implicitly, requires folding ofNspA protein into its
"native conformation" or into a conformation that "ha[ s] the activity of the
native protein," Appellants fail to establish an evidentiary basis on this
record to support a conclusion that a person of ordinary skill in this art
would have not reasonably expected success in folding ofNspA protein into
its "native conformation" or into a conformation that "ha[ s] the activity of
the native protein," using SB-12, a known, economical, substitute for
Zwittergent 3, 14 (see Supp. Br. 3-5; cf FF 1-7; see generally Ans. 5). See
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Appeal2014-003289
Application 12/693,271
KSR 550 U.S. at 421; see also In re O'Farrell, 853 F.2d 894, 903 (Fed. Cir.
1988) ("Obviousness does not require absolute predictability of success ...
all that is required is a reasonable expectation of success").
For the reasons provided by Examiner, we recognize, but are not
persuaded by, Appellants' contentions regarding Burgess (FF 8; Ans. 5;
cf Supp. Br. 4--5).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness. The rejection of claim 1 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Jansen and Brodeur is
affirmed. Claims 3-9, 12, and 13 are not separately argued and fall with
claim 1.
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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