Ex Parte Cummings

Patent Trial and Appeal Board

Jun 23, 2016

13363670 (P.T.A.B. Jun. 23, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/363,670 02/01/2012
20350 7590 06/27/2016
KILPATRICK TOWNSEND & STOCKTON LLP
Mailstop: IP Docketing - 22
1100 Peachtree Street
Suite 2800
Atlanta, GA 30309
Larry J. Cummings
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.
94262-829174 (09331 OUS) 4025
EXAMINER
CARRILLO, BIBI SHARIDAN
ART UNIT PAPER NUMBER
1711
NOTIFICATION DATE DELIVERY MODE
06/27/2016 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):
ipefiling@kilpatricktownsend.com
j lhice@kilpatrick.foundationip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LARRY J. CUMMINGS
Appeal2014-009162
Application 13/363,670
Technology Center 1700
Before TERRY J. OWENS, GEORGE C. BEST, and BRIAND. RANGE,
Administrative Patent Judges.
OWENS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
The Appellant appeals under 35 U.S.C. § 134(a) from the Examiner's
rejection of claims 1--4 and 6-17. We have jurisdiction under
35 U.S.C. § 6(b).
The Invention
The Appellant claims a method for cleaning an apatite solid surface.
Claim 1 is illustrative:
1. A method for cleaning an apatite solid surface following
target molecule purification by a non-adsorbing flow through
process, the method comprising,
(a) contacting a sample comprising the target molecule to
an apatite solid surface thereby flowing the target molecule past
the apatite solid surface;
Appeal2014-009162
Application 13/363,670
(b) neutralizing the apatite solid surface by contacting the
apatite solid surface with a sufficient concentration and volume
of an alkaline hydroxide; and
( c) after the step of neutralizing with alkaline hydroxide,
cleaning the apatite solid surface, thereby eluting adsorbed
biological compounds, wherein the cleaning comprises
contacting the apatite solid surface with a phosphate solution.
Shirasawa
V edantham
Gagnon
Cummings
The References
us 4,859,342
US 2003/0166869 Al
US 2009/0186396 Al
US 2011/0178276 Al
The Rejections
Aug. 22, 1989
Sep.4,2003
July 23, 2009
July 21, 2011
The claims stand rejected as follows: claims 1--4, 6-9, 11-14, 16,
and 17 under 35 U.S.C. § 102(b) over Vedantham, claim 10 under
35 U.S.C. § 103 over Vedantham in view of Gagnon, and claim 15 under
35 U.S.C. § 103 over Vedantham in view of Cummings or Shirasawa.
OPINION
We reverse the rejections. We need address only the sole independent
claim, i.e., claim 1. 1 That claim requires neutralizing an apatite solid surface
with alkaline hydroxide and then cleaning the apatite solid surface by
contacting it with a phosphate solution, thereby eluting adsorbed biological
compounds. 2
1 The Examiner does not rely upon Gagnon, Cummings or Shirasawa for any
disclosure that remedies the deficiency in V edantham as to the independent
claim and, in the 35 U.S.C. § 103 rejections, does not rely upon any
obviousness rationale regarding the independent claim's limitations (Ans. 3-
4).
2 The Appellant states that hydrogen (or hydronium) ions can accumulate on
an apatite solid surface following flow-through purification of a target
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Application 13/363,670
"Anticipation requires that every limitation of the claim in issue be
disclosed, either expressly or under principles of inherency, in a single prior
art reference." Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868
F.2d 1251, 1255-56 (Fed. Cir. 1989).
Vedantham discloses a flow-through method "for separating a protein
from one or more other proteins using hydroxyapatite chromatography in
which the protein does not bind to the hydroxyapatite but the other protein(s)
does" (Abstract; i-fi-159---60), wherein the proteins can be in a solution
comprising a buffer and/or a salt (i-f 58). After the flow-through separation,
proteins that remain bound to the hydroxyapatite may be released by
stripping the chromatography medium using a solution comprising the buffer
or salt used for chromatography, but at a higher molarity (i-f 61 ). The
chromatography medium then may be regenerated using a solution, such as a
sodium hydroxide solution, that releases most or all proteins from the
chromatography medium and reduces or eliminates any microbial
contamination in the chromatography medium (see id.). In an example a
hydroxyapatite chromatography medium, after being used for a flow-through
separation, is washed with three column volumes of 25 millimolar sodium
phosphate (pH 6.8), stripped using three column volumes of 0.4 molar
sodium phosphate (pH 6.8), regenerated using two column volumes of
1 molar sodium hydroxide, rinsed with three column volumes of 0.1 molar
molecule, and that neutralizing the apatite solid surface with an alkaline
hydroxide solution prior to cleaning it (e.g., with a 0.1-1.0 phosphate
solution) can avoid significant degradation of the apatite solid surface which
otherwise can occur due to displacement of the apatite's calcium ions
(Spec. ,-r 20).
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Appeal2014-009162
Application 13/363,670
sodium hydroxide/I 0 millimolar sodium phosphate, and stored in a solution
having the rinsing solution's composition for reuse (i-f 67).
The Examiner argues that Vedantham's regeneration with 1 molar
sodium hydroxide corresponds to the Appellant's neutralizing with alkaline
hydroxide because it uses an alkaline hydroxide concentration within the
range recited in the Appellant's claim 4 (i.e., "between 0.1 and 1 M")
(Ans. 2, 6).
Larry J. Cummings' Declaration under 37 C.F.R. § 1.132 states that
the Appellant's "alkaline hydroxide neutralizes the apatite by displacing
accumulated hydronium ions on the surface of the apatite into the liquid
phase where most of it forms water with hydroxide ion" (Deel. i1 7) whereas
"contacting the apatite with alkaline hydroxide after a cleaning/stripping is
performed, as in the V edantham reference, is not a neutralization step
because, after cleaning, the apatite surface does not have sufficient
accumulated hydronium ions to be neutralized" (id.).
The Examiner responds that "Appellant's arguments of H+ ions
already being released are not persuasive as they are not commensurate in
scope with the instantly claimed invention" (Ans. 6).
"' [D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification."' In re
Translogic Tech. Inc., 504 F.3d 1249, 1256 (Fed. Cir. 2007) (quoting In re
Hyatt, 211F.3d1367, 1372 (Fed. Cir. 2000)). The Appellant's claim 1
requires "neutralizing the apatite solid surface by contacting the apatite solid
surface with a sufficient concentration and volume of an alkaline
hydroxide". The Appellant's Specification states that "'[n]eutralizing the
solid apatite surface' refers to treating the surface of the apatite surface such
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Appeal2014-009162
Application 13/363,670
that the solid surface does not contain sutlicient hydronium ions to
significantly affect (i.e., cause a greater than 0.2 acidic pH shift of) the pH of
a subsequent cleaning buffer" (Spec. i-f 12). Thus, the broadest reasonable
interpretation of claim 1 's "neutralizing" requires that it reduces the number
of hydronium ions on the solid apatite surface. The Examiner has not
established that hydronium ions remain on Vedantham's hydroxyapatite
chromatography medium surface after Vedantham's washing and stripping
of that surface with sodium phosphate (i-f 67) such that Vedantham's
subsequent regeneration with 1 molar sodium hydroxide provides the
neutralizing required by the Appellant's claim 1.
Regarding the Appellant's claim 1 's requirement of cleaning the
apatite solid surface, thereby eluting adsorbed biological compounds, the
Examiner asserts that Vedantham's washing the hydroxyapatite
chromatography medium with 25 millimolar sodium phosphate elutes
proteins (Ans. 3).
The Appellant's claim 1 requires that the cleaning which elutes
adsorbed biological compounds occurs after the neutralizing. Vedantham's
washing with 25 millimolar sodium phosphate, however, occurs before the
regeneration with 1 molar sodium hydroxide (i-f 67) which the Examiner
relies upon as corresponding to the Appellant's neutralizing (Ans. 2). The
Examiner, therefore, erred in considering Vedantham's washing to
correspond to the Appellant's cleaning.
Larry J. Cummings' Declaration under 37 C.F.R. § 1.132 states that
Vedantham's rinsing with 0.1 molar sodium hydroxide/IO millimolar
sodium phosphate does not elute adsorbed biological compounds because it
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Application 13/363,670
is milder than the preceding stripping with 0.4 molar sodium phosphate and
regeneration with 1 molar sodium hydroxide (i-f 67) (Deel. 4).
The Examiner asserts that "[ s ]ince Vedantham et al. teach that
proteins are eluted with sodium phosphate and further teaches rinsing the
column with sodium phosphate, inherently biological compounds are eluted
because V edantham et al. is performing the same methods steps of
contacting with sodium phosphate as the instantly claimed invention"
(Ans. 3).
The Examiner's reliance upon Vedantham's washing with
25 millimolar sodium phosphate as meeting the Appellant's claim 1 's
elution requirement is erroneous as explained above, and the Examiner
provides no explanation as to how Vedantham's rinsing elutes adsorbed
biological compounds. As for the Examiner's assertion that Vedantham
performs the Appellant's method of contacting with sodium phosphate, the
Examiner has not established that Vedantham neutralizes an apatite solid
surface prior to cleaning it with a phosphate solution which elutes adsorbed
biological compounds.
Accordingly, we reverse the rejections.
DECISION/ORDER
The rejections of claims 1--4, 6-9, 11-14, 16, and 17 under
35 U.S.C. § 102(b) over Vedantham, claim 10 under 35 U.S.C. § 103 over
Vedantham in view of Gagnon, and claim 15 under 35 U.S.C. § 103 over
Vedantham in view of Cummings or Shirasawa are reversed.
It is ordered that the Examiner's decision is reversed.
REVERSED
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