Ex parte Saito et al.

Board of Patent Appeals and Interferences

Sep 21, 2000

08082373 (B.P.A.I. Sep. 21, 2000)

Application for patent filed June 28, 1993. According to appellants, this application is a1
continuation-in-part of application 07/606,205 filed October 31, 1990, now abandoned.
Appellants withdrew claims 8, 11 and 16 from consideration on appeal (see reply brief, page 2) and2
cancelled claims 8, 11 and 16 in the amendment filed July 26, 1996 (Paper No. 20). Although the examiner
authorized entry of the amendment in a hand-written notation thereon, i.e., "OK to enter SCW," the
amendment has not been physically entered. Therefore, upon return of the application to the jurisdiction of
the examiner, this clerical oversight should be corrected.
The opinion in support of the decision being entered today was not written for publication
and is not binding precedent of the Board.
Paper No. 23
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte TOMO SAITO and MIKIO IKEDA
____________
Appeal No. 1997-2387
Application No. 08/082,3731
____________
ON BRIEF
____________
Before WINTERS, SPIEGEL, and ADAMS, Administrative Patent Judges.
SPIEGEL, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the examiner's final
rejection of claims 1 through 7, 9, 10 and 12 through 19, which are all of the claims pending
in this application. Claims 1 and 4 are illustrative and read as follows.2
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Application No. 08/082,373
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1. An indirect agglutination immunoassay comprising the steps of:
contacting, in a container, a test sample containing a desired analyte
and a reagent comprising sensitized magnetic-material containing particles
containing iron, wherein said sensitized magnetic-material containing
particles have immobilized thereon an antigen or antibody which specifically
binds to said desired analyte,
precipitating said sensitized magnetic-material containing particles
by the application of magnetic force,
allowing said container to stand at an inclination, and
detecting the presence or absence of an immune reaction from the
absence or presence, respectively, of slippage of the precipitated sensitized
magnetic-material containing particles on the bottom of said container.
4. An apparatus for conducting an indirect agglutination immunoassay
comprising:
(a) a container for immunoassay, and sensitized magnetic-
material containing particles having immobilized thereon an
antigen or antibody,
(b) a magnetic sedimentation means for magnetically
precipitating the components containing the magnetic particles
at the bottom of the container, and
(c) an inclination means for allowing the container to stand at an
inclination after removal of the magnetic sedimentation means.
Appeal No. 1997-2387
Application No. 08/082,373
We refer to the English language translation prepared by the United States Patent and Trademark3
Office in April 1991 and supplied to appellants with the examiner's supplemental answer.
At page 3 of the answer, the examiner lists "3-173093 TAKAHASHI (Japan) 12-1992" as the "prior4
art of record relied upon in the rejection of the claims under appeal." While, it appears that the examiner is
relying on the actual Japanese document, we cannot find an English language translation of this document
in this record. Rather, what we find is an English abstract. Thus, it appears that the examiner and
appellants have been relying upon the English abstract. Consequently, our decision is also based on a
consideration of the English abstract.
Upon return of the application, the examiner should clarify the record as to what evidence of
obviousness is relied upon in support of the prior art rejections of record. Furthermore, when relying on non-
English documents as evidence of obviousness, a full translation should always be used when readily
available. See In re Meinhardt, 392 F.2d 273, 280, 157 USPQ 270, 275 (CCPA 1968) ("...it is proper for the
court and necessarily, the board, to consider everything that a reference discloses.").
Finally, the examiner stated "that since claim 7 now recites a flat bottomed well, which was not
disclosed in the parent application or the translated priority documents, it receives ... [a] June 28, 1993
[filing date]" (answer, p. 8, para. 1). Thus, the Takahashi abstract qualifies as prior art against claim 7.
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The references relied on by the examiner are:
Bernoco et al. (Bernoco) 4,148,607 Apr. 10, 1979
Forrest 4,438,068 Mar. 20, 1984
Chagnon et al. (Chagnon) 4,628.037 Dec. 9, 1986
Sakuma 4,770,855 Sep. 13, 1988
Japanese Patent Applications
Japan Kokai (JP '161) 59-1951161 Nov. 6, 19843
Japan (Takahashi abstract) 4-369477A Dec. 22, 19924
An additional reference relied on by appellants (brief, p. 13) is:
Eur. Patent Application 030 087 Jun. 10, 1981
Appeal No. 1997-2387
Application No. 08/082,373
The final rejection of claims 1-3 and 8-19 under 35 U.S.C. § 112, first and second paragraphs, was5
withdrawn by the examiner in view of appellants' arguments (answer, p. 2). The withdrawal from
consideration on appeal and subsequent cancellation of claims 8, 11 and 16 renders moot the final
rejections of claims 8, 11 and 16 under 35 U.S.C. § 112, first and second paragraphs, and under 35 U.S.C.
§ 103 as unpatentable over Bernoco in view of JP '161 as applied to claims 1-3, 9, 10, 12-15 and 17-19, and
further in view of Chagnon.
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ISSUES5
Claims 1-3, 9, 10, 12-15 and 17-19 stand rejected under 35 U.S.C. § 103 as
being unpatentable over Bernoco in view of JP '161. Claims 4 and 6 stand rejected under
35 U.S.C. § 102(b) as being anticipated by Forrest. Claim 5 stands rejected under 35
U.S.C. § 103 as being unpatentable over Forrest in view of Sakuma. Claim 7 stands
rejected under 35 U.S.C. § 103 as being unpatentable over Forrest in view of the
Takahashi abstract.
We reverse all four rejections.
In reaching our decision in this appeal we have given careful consideration to the
appellants' specification and claims and to the respective positions articulated by the
appellants and the examiner. We make reference to the examiner's answer (Paper No.
18, mailed March 8, 1996) and to the supplemental examiner's answer (Paper No. 21,
mailed August 7, 1996) for the examiner's reasoning in support of the rejections to the
appellants' brief (Paper No. 17, filed December 13, 1995) and to appellants' reply brief
(Paper No. 19, filed May 8, 1996) for the appellants' arguments thereagainst.
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Application No. 08/082,373
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OPINION
1. Rejection of claims 4 and 6 under § 102(b) as anticipated by Forrest
Anticipation requires that all elements of the claimed invention be described, either
expressly or under the principles of inherency, in a single prior art reference. In re Paulsen,
30 F.3d 1475, 1478-79, 31 USPQ2d 1671, 1673 (Fed. Cir. 1994); In re Spada, 911 F.2d
705, 708, 15 USPQ2d 1655, 1657 (Fed. Cir. 1990).
Forrest discloses an assembly for use in immunoassays utilizing magnetically
attractable particles, comprising two independent components, (a) a plurality of test tubes
fixed to a planar support member and (b) a substantially planar base member having one
or more magnet means permanently located therein, wherein the assembly can be
manually inverted without movement of the test tubes relative to the planar support or the
base (abstract; c. 2, ll. 11-50). According to the examiner, the support member which
holds the test tubes "is inherently capable of resting on its side and the bottom of the test
tubes, effectively providing an incline. (see Figure 1)" (answer, sentence bridging pp. 6-7).
The dispositive question is whether claim 4 and its dependent claims all require an
apparatus having three separate components, i.e., a container, a magnetic sedimentation
means and an inclination means separate from the container for tilting the container, as
argued by appellants (brief, pp. 19-21; reply brief, pp. 6-9); or, whether the claimed
Appeal No. 1997-2387
Application No. 08/082,373
See e.g., specification Reference Example 2, especially p. 18, ll. 3-7; Example 2, especially 6
p. 20, ll. 15-20; and Example 3, especially p. 22, ll. 5-10.
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inclination means can be integrated with the container as argued by the examiner
(supplemental answer, p. 4, ll. 13-16).
Here, when reading the apparatus claims in light of the specification, we agree with
appellants that "Claim 4, and all claims dependent thereon, require a separate device, an
‘inclination means’ which allows ‘the container’ to stand at an inclination after removal of
the magnetic sedimentation means" (reply brief, p. 6, ll. 14-17). Therefore, since Forrest6
does not disclose or suggest a separate inclination means as required by claim 4 and its
dependent claims, the rejection of claims 4 and 6 under § 102(b) as anticipated by Forrest
is reversed.
2/3. Rejections of claims 5 and 7 under § 103 as unpatentable over Forrest in view of
Sakuma and the Takahashi abstract
To establish a prima facie case of obviousness, there must be both some
suggestion or motivation to modify the reference or combine reference teachings and a
reasonable expectation of success. Furthermore, the prior art must teach or suggest all
the claim limitations. In re Vaeck, 947 F.2d 488, 493, 20 USPQ2d 1438, 1442 (Fed. Cir.
1991).
The examiner relies on Sakuma (Prior Art Figures 1 and 2) to show the
conventional use of v-shaped reaction vessels in the art of agglutination immunoassay
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(answer, p. 7, ll. 4-7). The examiner relies on the Takahashi abstract to show use of a flat-
bottomed reaction vessel in conjunction with a semispherical magnet to form a
sedimentation image which does not depend on the shape of the bottom of the reaction
vessel (answer, p. 7, ll. 19-22). However, neither Sakuma nor the Takahashi abstract
remedy the deficiency in Forrest. Since none of Forrest, Sakuma or the Takahashi
abstract disclose or suggest an apparatus comprising the separate inclination means
required by claim 4 and its dependent claims, the rejections of claims 5 and 7 under
§ 103 over Forrest in view of Sakuma and Forrest in view of the Takahashi abstract,
respectively, are reversed.
4. Rejection of claims 1-3, 9, 10, 12-15 and 17-19 under § 103 as unpatentable over
Bernoco in view of JP '161
Bernoco discloses that, when using a group of vessels disposed in rows in a
perpendicular arrangement, e.g., in a rectangle or a square on a support, the "agglutination
after centrifugating for any given kind of [agglutination] reaction is not the same for each
vessel" because it is impossible to arrange the axis of each vessel completely coaxially
with the direction of the centrifuging force (c. 1, ll. 21-40). Bernoco obviates this problem
by providing a process and apparatus wherein "the direction of the centrifugal force is
completely coaxial with the axis of the vessel" (c. 1, ll. 55-61). More specifically, in the
process of Bernoco
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...(a) a specimen for analysis is mixed with one or more reagents in a vessel
of progressively decreasing cross-section; (b) the mixture is incubated; (c)
the incubated mixture is then centrifuged at least one [sic, once] so as to hurl
the particles onto the vessel base, the same being disposed substantially in
the direction of the centrifugal force, with the result that the agglutinated
particles stick to the vessel base whereas the unagglutinated elements
remain free thereon, whereafter (d) centrifuging is stopped and ... the nature
of the reaction which has occurred is determined by observing the presence
or absence of the agglutinated or non-agglutinated elements, after a time
interval sufficient for their separation. [C. 1, l. 64 - c. 2, l. 12.]
I. If the reaction is positive, agglutination is complete and the
agglutinates remain stuck to the vessel base portion 7;
II. If the reaction is completely or partly negative, the non-agglutinated
elements, e.g.[,] the non-agglutinated red globules, slide down from the
vessel base 7 along the inclined wall 6 (FIG. 1).
The slide-down [i.e., slippage] does not start immediately upon the
cessation of centrifuging but usually starts after a short wait. Also, the rate of
sliding may vary according to the nature and intensity of the reaction
occurring, and so measurement of the rate of sliding gives further information
on the extent of negative reactions. [C. 4, ll. 49-61.]
The chart in column 4 illustrates various combinations of specimens and reagents useful
for routine blood grouping, including combinations of a plasma specimen with a sensitized
particulate reagent, i.e., "globules" having A , A , B or O antigens thereon. 1 2
JP '161 describes 1-100 µ ferromagnetic circular particles which can immobilize
various proteins, e.g., antigen, antibody and enzyme, and sugar groups (translation,
p. 2), and can be used "as the carrier of the indirect passive flocculation reaction, and the
flocculating reaction time is reduced to about half" (translation, sentence bridging pp. 11-
12).
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Application No. 08/082,373
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According to the examiner, it would have been obvious to use the ferromagnetic
particles of JP '161 as the particle reagent of Bernoco and the magnetic separation of JP
'161 in place of the centrifugal separation of Bernoco because the ferromagnetic particles
of JP '161 are physically and chemically uniform and stable, economically mass produced
and specifically suggested as suitable carriers for agglutination reactions whereby
agglutination reaction time can be shortened by about half and because the process of
Bernoco not only encompasses both simple and complex agglutination reactions but also
makes possible reliable automated measurements using very small amounts of reagents
and specimen. Noting that the process of Bernoco determines agglutination by the
amount of slippage observed after sedimentation, the examiner concludes that one of
ordinary skill in the art "would have been capable of providing the [necessary] inclination
means ... subsequent to separation." [Answer, p. 5, para. 2.]
Here, we agree with appellants that the examiner has not established a prima facie
case of obviousness because the fact that the prior art reference could be so modified to
show the patented invention would not have made the modification obvious unless the prior
art suggested the desirability of the modification. In re Gordon, 733 F.2d 900, 902, 221
USPQ 1125, 1127 (Fed. Cir. 1984). First, the examiner has not explained what would
have motivated one of ordinary skill in the art to modify the process and apparatus of
Bernoco, directed to providing coaxially directed centrifugal force to agglutination
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reactions, by totally doing away with said centrifugation. The centrifugal agglutination
apparatus of Bernoco would be no more. Second, the shortened agglutination reaction
times alluded to by JP '161 might be due to an increased density of ferromagnetic
particles relative to other prior art reagent particles, which may result in quicker
sedimentation of the ferromagnetic particles upon standing. Third, since the relative
speed of centrifugally accelerated separation depends on factors including the distance
from the center of rotation to the bottom of the vessel in the rotor cavity or bucket during
centrifugation and the speed of rotation of the rotor, the skilled artisan might just as easily
have modified either one of these two factors rather completely replacing the coaxially
directed centrifugal separation step of Bernoco with a magnetic separation step. Finally,
when a reference is relied on to support a rejection even in a "minor capacity," ordinarily
that reference should be positively included in the statement of rejection. In re Hoch, 428
F.2d 1341, 1342 fn 3, 166 USPQ 406, 407 fn 3 (CCPA 1970). Thus, we have not
considered the Davis disclosure in this rejection (answer, p. 9). Accordingly, we find that
the examiner has not carried her burden of establishing a prima facie case of
obviousness and has relied on impermissible hindsight in making his determination of
obviousness. In re Fritch, 972 F.2d 1260, 1266, 23 USPQ2d 1780, 1784 (Fed. Cir. 1992)
(It is impermissible to engage in hindsight reconstruction of the claimed invention, using
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the applicant’s structure as a template and selecting elements from references to fill the
gaps.).
Having concluded that the examiner has not established a prima facie case of
obviousness, we do not reach appellants' evidence of unexpected results (brief,
pp. 15-16).
The rejection of claims 1-3, 9, 10, 12-15 and 17-19 under § 103 as unpatentable
over Bernoco in view of JP '161 is reversed.
OTHER ISSUES
35 U.S.C. § 112, sixth paragraph, provides explicit guidance for interpreting terms
written in a "means-plus-function" format.
An element in a claim for a combination may be expressed as a
means or step for performing a specified function without the recital of
structure, material, or acts in support thereof, and such claim shall be
construed to cover the corresponding structure, material, or acts described
in the specification and equivalents thereof.
If the specification lacks a disclosed "corresponding structure" for performing the function
recited in the claims, neither an actual means nor means that are "equivalent" to the actual
means can be determined and the claims are indefinite under § 112, second paragraph.
Here, claim 4 contains terms written in a "means-plus-function" format. Upon return
of this application, the examiner should take a step back and evaluate whether the
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specification discloses "corresponding structure" for performing the function recited in the
claim and take appropriate action, if deemed necessary.
CONCLUSION
To summarize, the decision of the examiner to (1) reject claims 1-3, 9, 10, 12-15
and 17-19 under 35 U.S.C. § 103 as being unpatentable over Bernoco in view of JP '161
is reversed, (2) to reject claims 4 and 6 under 35 U.S.C. § 102(b) as being anticipated by
Forrest is reversed, (3) to reject claim 5 under 35 U.S.C. § 103 as being unpatentable over
Forrest in view of Sakuma is reversed, and (4) to reject claim 7 under 35 U.S.C. § 103 as
being unpatentable over Forrest in view of the Takahashi abstract is reversed.
REVERSED
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
)
) BOARD OF PATENT
CAROL A. SPIEGEL ) APPEALS
Administrative Patent Judge ) AND
Appeal No. 1997-2387
Application No. 08/082,373
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) INTERFERENCES
)
)
)
DONALD E. ADAMS )
Administrative Patent Judge )
Appeal No. 1997-2387
Application No. 08/082,373
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OBLON, SPIVAK, MC CLELLAND,
MAIER AND NEUSTADT
1755 JEFFERSON DAVIS HIGHWAY
FOURTH FLOOR
ARLINGTON, VA 22202
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