Ex Parte Little et al

Patent Trial and Appeal Board

Sep 26, 2012

11564951 (P.T.A.B. Sep. 26, 2012)

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.
11/564,951 11/30/2006 Charles Little SACHP0160USA 3398
7590 09/26/2012
Thomas W. Adams
RENNER, OTTO, BOISSELLE & SKLAR, LLP
19th Floor
1621 Euclid Avenue
Cleveland, OH 44115
EXAMINER
ZALASKY, KATHERINE M
ART UNIT PAPER NUMBER
1777
MAIL DATE DELIVERY MODE
09/26/2012 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 PATENT TRIAL AND APPEAL BOARD
____________

Ex parte CHARLES LITTLE and BARRY L. HAYMORE
____________

Appeal 2011-003058
Application 11/564,951
Technology Center 1700
____________

Before ADRIENE LEPIANE HANLON, PETER F. KRATZ, and
MARK NAGUMO, Administrative Patent Judges.

KRATZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on an appeal under 35 U.S.C. § 134 from the
Examiner’s final rejection of claims 1-9, 16, 19, 30, 31, 37, 64-66, 68, and
71. We have jurisdiction pursuant to 35 U.S.C. § 6.

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Appellants’ claimed invention is directed to a displacement
chromatography process utilizing a polyaromatic polyanionic displacer
compound of a specified formula.
Claim 1 is illustrative and reproduced below:
1. A displacement chromatography process, comprising:
loading onto a stationary phase comprising an anion-exchange material a
mixture comprising one or more component to be separated;
displacing at least one of the one or more components from the
stationary phase by applying to the stationary phase a mixture
comprising a polyaromatic polyanionic displacer compound having
the general formula:
Cen (Ar)w
wherein Cen = a bond, an alkenyl group, an alkynyl group, a benzene
ring, a biphenylene, a naphthylene, or

wherein:
R = independently -H, C1-C4 alkyl, or C1-C4 hydroxyalkyl;
Z = independently -H, halogen, -OH, -OR, -NRCH2CH(OH)CH2OH, -
NR2,-N[CH2CH(OH)CH2OH]2, -NRC(CH2OH)3, -NRCH(CH2OH)2,
or
- N(R)(poly(alkylene oxide));
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w = 2 to the highest number of substitutable positions on Cen; and
Ar = (a), (b) and/or (c); and wherein, in the following (a), (b) and (c):
An¯ = independently sulfonate, phosphonate, phosphinate,
phosphate, a phosphate mono- or di-ester, sulfate, a sulfate mono-
ester; or boronate; G = independently H, C1-C6 alkyl, C1-C6 alkenyl,
C6-C10 aryl, halogen, nitro, hydroxy, C1-C6 alkoxy, cyano, -NH2, -
NRH, -NR2, -NHC(O)R, -CHO,-C(O)R; and
(a), (b) and (c) are:

The Examiner relies on the following prior art references as evidence
in rejecting the appealed claims:
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Shukla 6,828,436 B2 Dec. 7, 2004
Cramer 6,929,747 B2 Aug. 16, 2005

Amitava Kundu et al. Displacement Chromatography of Proteins using Low
Molecular Weight Anionic Displacers. Adsorption, Vol. 4 (1998), 373-381.
Bogdan Belgorodsky et al. β-Lactoglobulin as a Versatile Vehicle for
Various Ligands - Mapping of the Elusive Binding Sites. Meeting Abstracts -
Electrochemical Society. Vol. 801 (2008), pg. 953.
"Lactoglobulin", http://www.sigmaaldrich.comltechnical-service-home/pro
ductcatalog.html, accessed 26 November 2008, 1 page.

The Examiner maintains the following grounds of rejection:
Claims 1-9, 64, and 65 stand rejected under 35 U.S.C. § 102(b) as
being anticipated by Shukla. Claims 1-9, 16, 19, 30, 31, 37, 64-66, 68, and
71 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over
Cramer in view of Kundu.
We reverse the stated rejections.
The Examiner bears the initial burden, on review of prior art or on any
other ground, of presenting a prima facie case of unpatentability. In re
Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
All of the claims which are rejected as being anticipated by Shukla are
drawn to a chromatography process that employs a displacer compound
required to satisfy the compound formula specified in independent claim 1.
In asserting that Shukla describes a chromatography process that
corresponds with the process of claim 1, the Examiner maintains that an azo
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group (-N=N-) bridging two aromatic sulfonate groups in Shukla’s calcion1
displacer compound is read upon by the claimed displacer compound
formula of claim 1 when “Cen” of the claimed formula is a bond (Ans. 4, 12,
and 13; Shukla, col. 6, l. 66 –col. 7, l. 30). Contrary to the Examiner’s
rejection position, however, we agree with Appellants that claim 1 specifies
a direct link, not an azo chemical group, by the recited option of using a
bond as a bridge between the aryl groups in the formula of claim 1 (App. Br.
8-11; Reply Br. 3-7). The Examiner does not otherwise articulate how
Shukla anticipates rejected independent claim 1.
It follows that we reverse the Examiner’s anticipation rejection as it is
premised on an incorrect and unreasonably broad claim construction.
In addition, the Examiner’s efforts at presenting a prima facie case of
obviousness fall short. This is, in part, because the Examiner’s rejection is
premised on a misinterpretation of the disclosures of Cramer and Kundu,
and lacks adequate foundation by way of identifying a particular compound
disclosed by Cramer that may have been subjected to the Examiner’s
proposed modification in light of the teachings of Kundu, for reasons as
argued by Appellants (App. Br. 12-25; Reply Br. 7-11).
Concerning the obviousness of the displacer compound required by
the appealed claimed method, it is reasonable to apply a prima facie
obviousness test paralleling the test for making out of a prima facie case of
obviousness for a chemical compound that is employed by our reviewing
court, given that the Examiner bases the obviousness rejection on a proposed

1 According to Appellants, the calcion [structure (II)] compound of Shukla is
actually amaranth (App. Br. 10).
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modification of a displacer compound of Cramer to allegedly arrive at the
claimed subject matter (Ans. 7).
That test for prima facie obviousness for chemical compounds
is consistent with the legal principles enunciated in KSR.
While the KSR Court rejected a rigid application of the
teaching, suggestion, or motivation(“TSM”) test in an
obviousness inquiry, the Court acknowledged the importance of
identifying “a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in
the way the claimed new invention does” in an obviousness
determination. KSR, 127 S. Ct. at 1731. . . . Thus, in cases
involving new chemical compounds, it remains necessary to
identify some reason that would have led a chemist to modify a
known compound in a particular manner to establish prima
facie obviousness of a new claimed compound.
Takeda Chemical Industries Ltd. v. Alphapharm Pty. Ltd., 492 F.3d 1350,
1357 (Fed. Cir. 2007).

The Supreme Court’s analysis in KSR thus relies on
several assumptions about the prior art landscape. First, KSR
assumes a starting reference point or points in the art, prior to
the time of invention, from which a skilled artisan might
identify a problem and pursue potential solutions. Second, KSR
presupposes that the record up to the time of invention would
give some reasons, available within the knowledge of one of
skill in the art, to make particular modifications to achieve the
claimed compound. See Takeda, 492 F.3d at 1357 (“Thus, in
cases involving new chemical compounds, it remains necessary
to identify some reason that would have led a chemist to modify
a known compound in a particular manner to establish prima
facie obviousness of a new claimed compound.”). Third, the
Supreme Court's analysis in KSR presumes that the record
before the time of invention would supply some reasons for
narrowing the prior art universe to a “finite number of
identified, predictable solutions,” 127 S. Ct. at 1742. In Ortho-
McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc., 520
F.3d 1358, 1364 (Fed. Cir. 2008), this court further explained
that this “easily traversed, small and finite number of
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alternatives ... might support an inference of obviousness.” To
the extent an art is unpredictable, as the chemical arts often are,
KSR’s focus on these “identified, predictable solutions” may
present a difficult hurdle because potential solutions are less
likely to be genuinely predictable.
In other words, post-KSR, a prima facie case of
obviousness for a chemical compound still, in general, begins
with the reasoned identification of a lead compound.
Eisai Co. Ltd. v. Dr. Reddy's Laboratories Ltd., 533 F.3d 1353, 1359 (Fed.
Cir. 2008).

Here, for instance, the Examiner refers to Example 2 of Cramer,
wherein PG-PSNa3 is the identified displacer compound (Ans. 5 and 6;
Cramer, col. 18, l. 14). The Examiner does not propose modifying this
compound of Cramer to arrive at the claimed subject matter, which Example
2 displacer compound, as indicated by Appellants, is not within the scope of
the appealed claims (App. Br. 16). Rather, the Examiner turns to the general
chemical formula I for a displacer compound disclosed by Cramer (Ans. 6;
Cramer, col. 3, ll. 10, col. 4, l. 1). In so doing, the Examiner maintains that
the compound to be selected from Cramer’s general teachings, and which
compound would have been obvious to modify in light of the additional
teachings of Kundu so as to arrive at the claimed subject matter, is a
compound that is made by selecting certain options from among the
disclosed options for each of Ar, R1, R2, R3, Y1, Y2, Y3, X1, X2, and X3 of
Formula I (Ans. 6 and 7). However, as correctly argued by Appellants, the
Examiner’s tendered selection of a generic substituted aryl for each of R1,
R2, and R3 does not serve to identify a particular lead compound disclosed by
Cramer that is to be modified via Kundu’s teachings, even with the
Examiner’s assertion of a proposed substitution for the aryl group provided
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in the paragraph bridging pages 6 and 7 of the Answer, as argued by
Appellants (App. Br. 13-24; Reply Br. 8-10). Therefore, the Examiner has
not tendered a prima facie case of obviousness on this basis alone; that is, in
failing to particularly identify a compound taught by Cramer that one of
ordinary skill in the art would have been led to modify based on the
additional teachings of Kundu.
As an additional matter, we further note that the tendered obviousness
rejection lacks a sustainable rationale to effect the proposed modification in
light of the additional teachings of Kundu. In this regard, the Examiner has
not presented a persuasive rejoinder to Appellants’ substantive arguments
concerning the lack of a credible teaching, with a generally supported trend,
in Kundu that supports the Examiner’s asserted suggestion, “increased
displacement efficacy” (Ans. 7), for the proposed modification of any
particular displacer compound of Cramer via addition of more anionic
substituents thereto (Ans. 16; App. Br. 25-35; Reply Br. 11-13).
In this regard, “rejections 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” being asserted. In re Kahn, 441 F.3d 977, 988 (Fed. Cir.
2006) (quoted with approval in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007)). After all, rejections based on § 103(a) must rest on a factual
basis with these facts being interpreted without hindsight reconstruction of
the invention from the prior art. See In re Warner, 379 F.2d 1011, 1017
(CCPA 1967).
On this record, we reverse the Examiner’s obviousness rejection.

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ORDER
The Examiner’s decision to reject the appealed claims is reversed.

REVERSED

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