Ex Parte OKUDA et al

Patent Trial and Appeal Board

Jan 22, 2016

12237175 (P.T.A.B. Jan. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/237, 175 09/24/2008
23373 7590 01/26/2016
SUGHRUE MION, PLLC
2100 PENNSYLVANIA A VENUE, N.W.
SUITE 800
WASHINGTON, DC 20037
FIRST NAMED INVENTOR
Masahiro OKUDA
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.
Ql 10086 9303
EXAMINER
MARTIN, PAUL C
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
01/26/2016 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):
PPROCESSING@SUGHRUE.COM
sughrue@sughrue.com
USPTO@sughrue.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MASAHIRO OKUDA, YOSHIHITO YAMAMOTO,
AKIRA YOSHIOKA, MIDORI SHIMA, and MASAHIRO TAKEY AMA
Appeal2013-003295
Application 12/237, 175
Technology Center 1600
Before DONALD E. ADAMS, CHRISTOPHER G. PAULRAJ, and
TA WEN CHANG, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL 1
This appeal under 35 U.S.C. § 134(a) involves claims 1, 4--7, and 20-
25 (see generally App. Br. 4; Ans. 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' disclosure "relates to a method of inactivating a blood
coagulation factor" (Spec. 1:9-10). Claim 21 is representative and
reproduced in the Claims Appendix of Appellants' Brief.
1 Appellants identify the Real Party in Interest as "Sysmex Corporation"
(App. Br. 2).
Appeal2013-003295
Application 12/237, 175
Claims 1, 4--7, and 20-25 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Strahilevitz2 and Vassileva. 3
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Appellants'
invention relates to a method of inactivating a blood
coagulation factor, comprising a step of contacting a sample
containing at least one of factors V and VIII with a compound
having an iminodiacetate group-N(CH2COOR)2 wherein R
represents a hydrogen atom or a metallic ion, [such as sodium
ion,] whereby at least one of factors V and VIII in the sample is
changed into an inactivated form.
(Spec. 3:4--8 and id. at 5:6-7 ("The monovalent metallic ion includes, for
example, sodium ion").)
FF 2. Appellants' method "for contacting a sample with a compound
having an iminodiacetate group is not particularly limited" and encompasses
"a method wherein a sample is passed through a column charged with [a]
carrier [having an iminodiacetate group]" (Spec. 6: 10-11 and 14--15).
FF 3. Strahilevitz discloses "[ e ]xtracorporeal affinity adsorption treatments
which are aimed at the substantial removal of two or more compounds that
are etiological in the pathogenesis of diseases in man [to] provide effective
therapeutic intervention means for these diseases" (Strahilevitz, Abstract).
2 Strahilevitz, US 5,753,227, issued May 19, 1998.
3 E. Vassileva and N. Furuta, Application of iminodiacetate chelating resin
muromac A-1 in on-line preconcentration and inductively coupled plasma
optical emission spectroscopy determination of trace elements in natural
waters, 58 Spectrochimica Acta Part B 1541-1552 (2003).
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Appeal2013-003295
Application 12/237, 175
FF 4. Strahilevitz's "[e]xtracorporeal affinity adsorption treatment"
comprises the flow of blood and/or plasma through an apparatus that
"includes [a] chelating agent," such as Chelex 100, which is a compound
having an iminodiacetate group-N(CH2COOR)2 wherein R represents a
hydrogen (Strahilevitz 6:9-13 and 8:64---67; Ans. 3; cf FF 1).
FF 5. Strahilevitz discloses that while Chelex 100 is a preferred chelating
agent, other iminodiacetic acid derivatives may be used in Strahilevitz's
method (Strahilevitz 6:29-35).
FF 6. Examiner finds that Vassileva discloses the chelating agent,
Muromac A-1, which has an iminodiacetate group-N(CH2COOR)2 wherein
R represents a sodium ion (Vassileva 1542, col. 2, 11. 24--27; Ans. 4; cf FF
1 ).
FF 7. Examiner finds that "sugar will dissolve faster when stirred" (Ans.
6).
ANALYSIS
Appellants' invention comprises contacting a sample that contains "at
least one of factors V and VIII with a compound having an iminodiacetate
group-N(CH2COOR)2 wherein R represents a hydrogen atom or a metallic
ion, [such as sodium ion,] whereby at least one of factors V and VIII in the
sample is changed into an inactivated form" (FF 1 ). Appellants disclose that
the manner in which the sample is contacted with the compound "is not
particularly limited" and encompasses "a method wherein a sample is passed
through a column charged with [a] carrier [having an iminodiacetate group]"
(FF 2).
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Appeal2013-003295
Application 12/237, 175
Strahilevitz discloses a method wherein a sample, i.e. blood or
plasma, which contains at least one of factors V and VIII, is contacted with a
compound, i.e. Chelex-100, having an iminodiacetate group
-N(CH2COOH)2 (FF 3--4; cf FF 1-2). Strahilevitz is silent with respect to
the ability of the Chelex-100 resin to change at least one of factors V and
VIII in the sample into an inactivated form. "It is[, however,] a general rule
that merely discovering and claiming a new benefit of an old process cannot
render the process again patentable." In re Woodruff, 919 F. 2d 1575, 1578
(Fed. Cir. 1990).
While Strahilevitz prefers Chelex-100, Strahilevitz discloses that other
iminodiacetic acid derivatives may be used in Strahilevitz's method (FF 5).
One such iminodiacetic acid derivative, Muromac A-1, is disclosed by
Vassileva and has an iminodiacetate group-N(CH2COOR)2 wherein R
represents a sodium ion (FF 6; cf FF 1 ).
Therefore, we find no error in Examiner's conclusion that, at the time
Appellants' invention was made, it would have been prima facie obvious to
perform Strahilevitz's method using: (A) a compound having an
iminodiacetate group-N(CH2COOR)2 wherein R represents a metallic ion,
such as sodium ion, as suggested by Vassileva as an alternative to (B)
Strahilevitz's compound which has an iminodiacetate group
-N(CH2COOR)2 wherein R represents a hydrogen atom (Ans. 5; FF 3---6; cf
FF 1-2).
The Chelex-100 and Muromac A-1 resins are alternative resins that
fall within the scope of Strahilevitz's disclosure (FF 4---6; see Reply Br. 2).
Therefore, we are not persuaded by Appellants' contentions regarding the
substitution of Chelex-100 with Muromac A-1 (App. Br. 7-9).
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Appeal2013-003295
Application 12/237, 175
We recognize, but are not persuaded by Appellants' contention that no
motivation exists in the art to modify the references as proposed by
Examiner (App. Br. 9--10; Reply Br. 2-3). Notwithstanding Appellants'
contention to the contrary, Strahilevitz provides a reason to make the
modification by suggesting that other Chelex-100 alternatives may be used
in Strahilevitz's method (FF 5).
We recognize, but are not persuaded by, Appellants' unsupported
contention that "the method of Strahilevitz does not in fact inactivate factors
V and VIII, because doing so would be extremely deleterious to the patient
receiving such clotting factor-inactivated blood" (App. Br. 11 ). Argument
by counsel cannot take the place of evidence. In re Geisler, 116 F.3d 1465,
1471 (Fed. Cir. 1997).
As discussed above, Appellants disclose that contacting a sample
comprising at least one of factors V and VIII, in a manner that "is not
particularly limited," with "a compound having an iminodiacetate group
-N(CH2COOR)2 wherein R represents a hydrogen atom or a metallic ion,"
such as sodium ion, will change at least one of factors V and VIII in the
sample into an inactivated form (FF 1-2). Strahilevitz contacts a sample
containing at least one of factors V and VIII with a compound, Chelex-100,
having an iminodiacetate group-N(CH2COOH)2 (FF 4). Absent evidence to
the contrary, the Examiner has made a prima facie showing that this method
will inherently inactivate at least one of factors V and VIII present in the
sample (see FF 1-2). Strahilevitiz suggests the substitution of Chelex-100
with another reagent comprising an iminodiacetate group, such as
Vassileva's Muromac A-1 (FF 5-6). Absent evidence to the contrary, the
Examiner has made a prima facie showing that performing Strahilevitiz's
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Appeal2013-003295
Application 12/237, 175
method with Vassileva's Muromac A-1 will inherently inactivate at least one
of factors V and VIII present in the sample (see FF 1-2). Therefore, we are
not persuaded by Appellants' contentions regarding inherency (App. Br. 10-
13; Reply Br. 3-5).
"[W]here the Patent Office has reason to believe that a
functional limitation asserted to be critical for establishing
novelty in the claimed subject matter may, in fact, be an
inherent characteristic of the prior art, it possesses the authority
to require the applicant to prove that the subject matter shown
to be in the prior art does not possess the characteristic relied
on."
In re Best, 562 F.2d 1252, 1254--1255 (CCPA 1977) (quoting In re
Swinehart, 439 F.2d 210, 212-13 (CCPA 1971)). Therefore, we are not
persuaded by Appellants' contention that Examiner improperly "tries to shift
the burden to Appellant to provide evidence that inactivation does not occur"
in Strahilevitz's method (Reply Br. 4).
For the foregoing reasons, we are not persuaded by Appellants'
contention that: ( 1) Strahilevitz teaches away from Appellants' claimed
invention or (2) Examiner's combination of Strahilevitz and Vassileva
"render[s] Strahilevitz unsatisfactory for its intended purpose" (App. Br. 13-
15; Reply Br. 5-7).
Examiner further concludes that, at the time Appellants' invention
was made, it would have been prima facie obvious
to include a step[, in the method suggested by the combination
of Strahilevitz and Vassileva,] of stirring for 30 minutes or
more or 3 hours or less because those of ordinary skill would
have recognized that the passive flow of reactants through a
column would have a slower rate of reaction that if an agitation
was used during the contacting step. For example, in much the
same principle that sugar will dissolve faster when stirred,
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Appeal2013-003295
Application 12/237, 175
agitation increases the rate of contact between the sample and
the column reagents.
(Ans. 6; FF 7). In this regard, Examiner asserts that stirring time period is a
"result-effective adjustment of conventional working parameters [subject to]
routine optimization which is well within the purview of the skilled artisan"
(Ans. 6). In re Aller, 220 F.2d 454, 456 (CCPA 1955) ("[W]here the general
conditions of a claim are disclosed in the prior art, it is not inventive to
discover the optimum or workable ranges by routine experimentation.").
For the foregoing reasons, we are not persuaded by Appellants' contention
that the combination of Strahilevitz and Vassileva fails to suggest the stirring
requirements of Appellants' claim 1, which fails to account for Examiner's
reasoning (see Ans. 6 and 14--15).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
The rejection of claims 1and21under35 U.S.C. § 103(a) as
unpatentable over the combination of Strahilevitz and Vassileva is affirmed.
Claims 4--7 and 20 are not separately argued and fall with claim 1. Claims
22-25 are not separately argued and fall with claim 21.
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
KRH
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