Ex Parte Belew et al

Board of Patent Appeals and Interferences

Sep 20, 2010

10148032 (B.P.A.I. Sep. 20, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte MAKONNEN BELEW,
BO-LENNART JOHANSSON, and JEAN-LUC MALOISEL
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Appeal 2010-000779
Application 10/148,032
Technology Center 1700
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Before CHARLES F. WARREN, CATHERINE Q. TIMM, and
MARK NAGUMO, Administrative Patent Judges.

NAGUMO, Administrative Patent Judge.

DECISION ON APPEAL1

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.
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A. Introduction2
Makonnen Belew, Bo-Lennart Johansson, and Jean-Luc Maloisel
(“Belew”) timely appeal under 35 U.S.C. § 134(a) from the final rejection3
of claims 1-16. We have jurisdiction under 35 U.S.C. § 6. We REVERSE.
The subject matter on appeal relates to a method of removing a
substance carrying a negative charge from an aqueous solution with a
mixed-mode anion exchange resin. According to the 032 Specification, the
anion exchange resin has positively-charged-nitrogen-containing ligands in
which a thioether linkage is present to enhance the strength of the interaction
of the absorbant with the substance of interest.
Representative Claim 1 reads:
1. A method for the removal of a substance carrying a negative
charge from an aqueous liquid (I), said method comprising the
steps of
i) contacting the liquid with an anion-exchanger (1) that
comprises a base matrix carrying a plurality of
mixed mode anion-exchanging ligands in which
there is a positively charged nitrogen under
conditions permitting binding between the ligands
and the substance; and

2 Application 10/148,032, Method for Anion-Exchange Adsorption and
Thioether Anion-Exchangers, filed 10-September 2002, filed as the National
Stage of an international Application filed 22 November 2000, claiming the
benefit of a Swedish Application filed 22 November 1999. The
specification is referred to as the “032 Specification,” and is cited as “Spec.”
The real party in interest is listed as Amersham Biosciences AB (Appeal
Brief, filed 19 August 2005 (“Br.”), 2.)
3 Office action mailed 23 June 2004.
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ii) desorbing said substance from said anion-exchanger
by the use of a liquid (liquid (II)),
wherein
(A) all or a part of the plurality of mixed mode anion-
exchange ligands have a thioether linkage within a
distance of 1-7 atoms from its positively charged
nitrogen, and
(B) the anion-exchanger (1) is
(a) capable of binding the substance of interest in
an aqueous reference liquid (II) at an ionic strength
corresponding to 0.25 M NaCl, and
(b) exhibits in the pH interval 2-12 a maximal
breakthrough capacity for the substance of at
least 200% of the breakthrough capacity of the
substance for Q-Sepharose Fast Flow,
said anion-exchangers having essentially the
same ligand density and breakthrough
capacities being determined under the same
conditions.
(Br., Claims App. 1 (pages unnumbered); indentation, paragraphing, and
emphasis added.)
Claim 12 covers an anion-exchanger (1) in which the anion-exchange
ligand is defined by the formula:
--SP---[R5-S-R1-N+(R2R3R4)],
the particular details of which need not detain us. Claim 12 further requires
that the maximal breakthrough capacity for at least one of seven named
proteins be at least 200% of the maximal breakthrough capacity for a
“Q-exchanger (-CH2CH(OH)CH2N+(CH3)3),” with several conditions
specified as being the same for the anion-exchanger (1) and the reference
anion-exchanger (2). (Br., Claims App. 4-5 (pages unnumbered).)
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The Examiner has maintained the following grounds of rejection:4
A. Claims 1-11, 14, and 15 stand rejected under
35 U.S.C. § 102(b) in view of Burton.5
B. Claims 12, 13, and 16 stand rejected under 35 U.S.C. § 102(b)
in view of Burton.
B. Discussion
Findings of fact throughout this Opinion are supported by a
preponderance of the evidence of record.
Initially, we note that Belew presents arguments only for the separate
patentability of claims 1 and 12, and that the arguments for the patentability
of claim 12 are essentially the same as those for claim 1. (Br. 8-9.)
Accordingly, the claims stand or fall with claim 1.
37 C.F.R. § 41.37(c)(1)(vii) (2010).
Belew argues that Burton does not anticipate the claimed method
because the separation media described by Burton function based on
hydrophobic interactions, rather than by using the positively charged
nitrogen for adsorption by ionic interaction. (Br. 5.) This argument is not
persuasive because the claims do not require such an interaction. Rather,
claim 1 merely requires “mixed mode anion-exchanging ligands in which
there is a positively charged nitrogen under conditions permitting binding
between the ligands and the substance.” The 032 Specification defines the

4 Examiner’s Answer mailed 25 September 2009 (“Ans.”).
5 Simon C. Burton et al., Chromatographic Resins and Methods for Using
Same, U.S. Patent 5,652,348 (1997). (Burton is described in the
032 Specification at page 4, ll. 4-12.)
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term “mixed mode anion exchange ligand” as a ligand that can provide “at
least two different, but co-operative sites which interact with the substance
to be bound. One of the sites gives an attractive type of charge-charge
interaction between the ligand and the substance of interest. The second site
typically gives electron donor-acceptor interaction and/or hydrophobic
interactions.” (Spec. 1, ll. 22-27; emphasis added.) The use of the term
“bound” in this passage indicates a more general sense of the term than
“chemical bonding.” In this regard, Burton describes ligands having both
positively chargeable nitrogens and regions that have hydrophobic
interactions with the substances of interest. Belew has not come forward
with any credible evidence or explanation showing that the interactions
required by claim 1 are not also met by the mixed-mode resins described by
Burton.
Belew further seeks to distinguish the mechanism of action of the
inventive resin from that described by Burton, arguing that “the anion
exchange resin is used to bind the target substance in the liquid, which can
then be desorbed by changing the ionic strength of the solution and/or
the pH.” (Br. 6, last para.; citation to the 032 Specification omitted.) In
addition to this mechanism not being recited in claim 1, we note that Burton
teaches that desorption can be accomplished by changing the pH. (Burton,
col. 1, ll. 8-12; col. 14, ll. 17-27.) This purported distinction does not serve
to remove Burton as an anticipatory reference.
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Finally, Belew argues that the Examiner failed to establish a prima
facie case that the maximal breakthrough capacity6 condition recited in
claims 1 and 12 is inherent in the resins described by Burton. (Br. 7; 9.)
The Examiner argues that “because the ligand meets the criteria of
applicant’s claim and specification, it is inherent that the maximal
breakthrough capacity for a substance is greater than 200% of the
breakthrough capacity of the substance for Q-sepharose fast flow.”
(Ans. 4; 5.) The Examiner does not further develop or explain the basis or
the reasons for this conclusion.
According to the 032 Specification, appropriate anion-exchangers
may be selected for the invention by screening for “increased maximal
elution ionic strength for the substance (carrying the negative charge)
compared to the elution ionic strength required for the same substance on a
conventional anion-exchanger.” (Spec. 7, ll. 23-26.) The comparisons,
the 032 Specification emphasizes, must be “performed under essentially the
same conditions for anion exchanger (1) and (2), i.e., essentially the same
support matrix (support material, bead size, pore sizes, pore volume, packing
procedure etc), pH, temperature, solvent composition, number of charged
ligands having the formula given above etc.” (Spec. 8, ll. 1-5.) Thus, the
anion exchanger recited in claim 1 and claimed in claim 12 is not merely a
composition of matter (a polymer), but an article of manufacture. The
Examiner has not explained why the recited maximal breakthrough property
recited in the claims would have been “necessarily present in the thing

6 Belew and the Examiner also refer to this term as the “maximum elution
ionic strength.” (Br. 7; Ans. 4.)
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described in the reference.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir.
1999). Put another way, the Examiner has not shown that the resins
described by Burton are the same or substantially the same as those required
by the claims, and has therefore failed to transfer the burden to Belew to
show that they are not. Cf. In re Best, 562 F.2d 1252, 1255 (CCPA 1977)
We conclude that Belew has shown harmful error in the Examiner’s
rejections and we therefore REVERSE.
C. Order
We REVERSE the rejection of claims 1-16 under 35 U.S.C. § 102(b)
in view of Burton.
REVERSED

sld

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