Ex Parte Zheng et al

Board of Patent Appeals and Interferences

Jun 15, 2010

10736004 (B.P.A.I. Jun. 15, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte YI FENG ZHENG, HSHIOU-TING LIU
and YALI YANG
__________

Appeal 2010-001050
Application 10/736,004
Technology Center 1600
__________

Decided: June 15, 2010
__________

Before ERIC GRIMES, DEMETRA J. MILLS, and
MELANIE L. McCOLLUM Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
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Application 10/736,004
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STATEMENT OF CASE
The following claim is representative.
25. A method for determining methylenedioxyamphetamine and/or
methylenedioxymethamphetamine and/or methylenedioxyethamphetamine
in a sample suspected of containing methylenedioxyamphetamine and/or
methylenedioxymethamphetamine and/or
methylenedioxyethamphetamine, said method comprising:
(a) providing in combination in a medium:
(i) said sample,
(ii) an antibody for methylenedioxyamphetamine, and/or
(iii) an antibody for methylenedioxymethamphetamine, and/or
(iv) an antibody for methylenedioxyethamphetamine, and
(v) a compound of the formula:

wherein:
R1' is H, or methyl or ethyl
R3' is H,
R4' is H, or methyl or ethyl,
R9 is -(CH2)nC(O),
Z' is an enzyme,
n is an integer from 1 to 5,
n' is an integer between 1 and the molecular weight of said enzyme
divided by about 500;
and
(b) examining said medium for the presence of a complex comprising said
methylenedioxyamphetamine and said antibody for
methylenedioxyamphetamine and/or a complex of said
methylenedioxymethamphetamine and said antibody for
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methylenedioxymethamphetamine and/or a complex of said
methylenedioxyethamphetamine and said antibody for
methylenedioxyethamphetamine, the presence thereof indicating the
presence of said methylenedioxyamphetamine and/or
methylenedioxymethamphetamine and/or methylenedioxyethamphetamine
in said sample.

Additional Appealed claims may be found in the Claims Appendix to the
Brief.
The Examiner relies on the following evidence:
Avenia et al. US 4,041,076 Aug. 9, 1977
Rouhani et al. GB 2361473 A Oct. 24, 2001
Hui EP 1340981 A2 Feb. 25, 2003

Grounds of Rejection
1. Claims 25, 27, 30 and 31 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Hui, in view of Avenia.
2. Claims 25, 27, 30 and 31 are rejected under 35 U.S.C. §103(a) as being
unpatentable over Rouhani in view of Avenia.

PRINICIPLES OF LAW
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).

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Discussion
Claims 25, 27, 30 and 31 are rejected under 35 U.S.C. 103(a) as being
unpatentable over Hui in view of Avenia. (Ans. 3.)

ISSUE
The Examiner finds that “it would have been obvious at the time of
the invention to a person of ordinary skill in the art to substitute equivalent
hapten, immunogen or antibody as disclosed by Avenia et al in the method
of Hui et al, with the expectation of obtaining a similarly useful
immunoassay method and kit for detection of amphetamine and
amphetamine derivatives.” (Id. at 4.)
Appellants contend that, “[t]he combined teaching[s] of Hui and
Avenia is deficient in not disclosing or suggesting at least the following
limitation of claim 25: "providing in combination in a medium, together with
the sample and the antibodies, an enzyme label conjugate of the formula set
forth in the claim having a -(CH2)nC(O) moiety linking the enzyme to the
molecule.” (App. Br. 8-9.)
The issue is: Do the cited references disclose or suggest the limitation
of claim 25: "providing in combination in a medium, together with the
sample and the antibodies, an enzyme label conjugate of the formula set
forth in the claim having a -(CH2)nC(O) moiety linking the enzyme to the
molecule.” (Id.)

FINDINGS OF FACT
1. “Hui… disclose[s] various competitive and noncompetitive
methods/assays and a kit for detection and quantitative determination of
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amphetamine derivatives such as MDA, MDMA, MDEA, MDPA, BDB,
MBDB etc (paragraphs [0012], [0024], [0029], [0064-0067], [0059] and
[0060]) using antibody against amphetamine derivatives and label
derivatives (such as fluorescent, luminescent, radioactive isotope etc.)
(paragraph [0022]).” (Ans. 3.)
2. “Hui's amphetamine derivatives and immunogens are similar to the
compound and immunogen of the present invention and are expected to
recognize different amphetamine derivatives suitable for different
immunoassays. However, the linking group or the position of linker at the
amphetamine derivative is different from the present compound.” (Id. at 3-
4.)
3. Hui discloses the creation of antibodies for detecting specific
amphetamine derivatives and their use in assays including competitive
assays. (Hui, ¶¶ 0066-0067.)
4. Hui describes an activated hapten which is a compound such as an
amphetamine derivative linked via a linking group or linker to a label which
may be an enzyme. (Hui, ¶¶ 0014-0022.) The linking group may or may
not be needed. (Hui, ¶ 0019.)
5. Avenia discloses a radioimmunoassay for amphetamine derivatives
which uses an amphetamine derivative having the linking group recited in
claim 25 to form haptens and raise antibodies (Avenia, col. 4, l. 59 to col. 5,
l. 10; abstract.)
6. “Avenia et al[.] disclose[s] amphetamine immunogen, labeled tracer
and antibodies … and disclose competitive immunoassay method for
detection of phenentylamines [sic, phenethylamines] (e.g. norepinephrine,
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dopamine, epinephrine and amphetamines).” (Ans. 4.) Labeled
phenethylamines may be enzyme labeled. (Avenia, col. 4, ll. 47-59.)
7. The Examiner finds that “[t]he immunogen of Avenia et al. is the
same as the immunogen of present application.” (Ans. 4.)
8. The Examiner concludes that “[s]ince detection of amphetamine,
methamphetamine and their derivatives is important in the field of ecstasy
drug and once a hapten, immunogen or an antibody is available, one of
ordinary skill in the art would obviously try to use the hapten and the
immunogen in different immunoassay methods to develop a better detection
assay for the drug.” (Id.)
9. The Examiner concludes that “given the above fact, it would have
been obvious at the time of the invention to a person of ordinary skill in the
art to substitute equivalent hapten, immunogen or antibody as disclosed by
Avenia et al in the method of Hui et al, with the expectation of obtaining a
similarly useful immunoassay method and kit for detection of amphetamine
and amphetamine derivatives.” (Id.)
10. “Claims recite methods, compositions and kits for detecting the
presence and/or amounts of entactogens in samples.” (Id. at 5.)
11. “Rouhani et al disclose[s] a method for detection of ecstasy-class
analogs.” (Id.)
12. “Rouhani discloses preparation of antibody (page 6, lines 19-24;
pages 16-18) using the compound conjugated with carrier protein (see
abstract) and different homogeneous and heterogeneous immunoassay
methods (pages 8-9 and 34) and assay kit (page 31, lines 9-12 and claim 10)
for detection and quantitation of ecstasy-class analogs in biological samples
(page 22, lines 19-24).” (Id. at 5.)
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13. “Rouhani also discloses the … compound conjugated with a protein to
be adapted as immunogen (page 41, example 7). Attachment to a carrier
protein or a label is also inherent in the process of immunization (see claims
7 and 8) and immunoassay methods (see pages 8-9 and 34) as disclosed in
this reference.” (Id.)
14. “Rouhani's amphetamine and methamphetamine derivatives and
immunogens are similar to the compound and immunogen of the present
invention and are expected to recognize different amphetamine derivatives
suitable for different immunoassays.” (Id.) Rouhani discloses an
immunoassay for ecstasy amphetamine derivatives that employs an enzyme
that undergoes change in activity. (Rouhani, 7.)
15. “However, the linking group or the position of linker at the
amphetamine derivative is different from the present compound.” (Ans. 5.)
16. “Avenia et al disclose[s] amphetamine immunogen, labeled tracer and
antibodies … and disclose [a] competitive immunoassay method for
detection of phenentylamines [sic, phenethylamines] (e.g. norepinephrine,
dopamine, epinephrine and amphetamines).” (Id.) The Examiner concludes
that the immunogen of Avenia et al is the same as the immunogen of present
application. (Id.)

ANALYSIS
The Examiner finds that “it would have been obvious at the time of
the invention to a person of ordinary skill in the art to substitute equivalent
hapten, immunogen or antibody as disclosed by Avenia et al in the method
of Hui et al, with the expectation of obtaining a similarly useful
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immunoassay method and kit for detection of amphetamine and
amphetamine derivatives.” (Id. at 4.)
Appellants contend that, “[t]he combined teaching[s] of Hui and
Avenia is deficient in not disclosing or suggesting at least the following
limitation of claim 25: ‘providing in combination in a medium, together with
the sample and the antibodies, an enzyme label conjugate of the formula set
forth in the claim having a -(CH2)nC(O) moiety linking the enzyme to the
molecule.’” (App. Br. 8-9.) More particularly, Appellants argue that there is
no mention in Avenia of a conjugate of a label and the haptens of Avenia
where the label is linking through the claimed linking moiety. (App. Br. 10.)
Appellants argue there is no disclosure in Avenia of linking a
phenethylamine to a label by means of the claimed linking moiety. (App.
Br. 10.)
We conclude that the Examiner has the better argument. In the
present case, the Examiner finds that Hui discloses the creation of antibodies
for detecting specific amphetamine derivatives and their use in assays
including competitive assays. (Hui, ¶¶ 0066-0067.) Hui describes an
activated hapten which is a compound such as an amphetamine derivative
linked via a linking group or linker to a label which may be an enzyme.
(Hui, ¶¶ 0014-0022.) The linking group may or may not be needed. (Hui, ¶
0019.) Hui does not disclose the claimed linker, so the Examiner relies on
Avenia which discloses a radioimmunoassay for amphetamine derivatives
which uses an amphetamine derivative having the claimed linking group to
form haptens and raise antibodies (Avenia, col. 4, l. 59 to col. 5, l. 10;
abstract.) It would have been obvious to one of ordinary skill in the art to
attach an enzyme label to the hapten of formula III of Avenia via the linker
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of Avenia and substitute the labeled hapten for the hapten of Hui and use it
in a competitive assay, as claimed.
Appellants further argue that the labeled radioisotope of Avenia does
not include the claimed linker, as the linker is used only as part of a hapten
or immunogen to create antibodies for the Avenia radioimmunoassay. (App.
Br. 11.) Finally, Appellants argue that radiolabelled phenethylamine with no
linking group performed better in a radioimmunoassay and therefore the
prior art teaches away from use of enzyme labeled amphetamine derivatives
attached via a linker in a competitive assay. (App. Br. 11.)
Appellants have provided no evidence that one of ordinary skill in the
art would not have been able to substitute the hapten of Avenia formula III
in the assay of Hui to detect amphetamine derivatives. Thus it would have
been obvious to substitute a homologous methamphetamine hapten or
immunogen having the claimed linker, for a known labelled amphetamine in
a known competitive assay. An “[e]xpress suggestion to substitute one
equivalent for another need not be present to render such substitution
obvious.” In re Fout, 675 F.2d 297, 301 (CCPA 1982). It is known to use
the claimed linking moiety as described in Avenia. The combination of
familiar elements (the linking moiety of Avenia in a methamphetamine
assay as in Hui) according to known methods is likely to be obvious when it
does no more than yield predictable results. KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 417 (2007).
We do not find that the prior teaches away from the combination of
the cited references. “A reference may be said to teach away when a person
of ordinary skill, upon reading the reference, would be discouraged from
following the path set out in the reference, or would be led in a direction
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divergent from the path that was taken by the applicant. The degree of
teaching away will of course depend on the particular facts; in general, a
reference will teach away if it suggests that the line of development flowing
from the reference’s disclosure is unlikely to be productive of the result
sought by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).
We find no suggestion in Avenia or Hui of an unproductive result from the
indicated combination and thus find no clear teaching away from the
combination as alleged by Appellants. “The fact that the motivating benefit
comes at the expense of another benefit, such as superior assay results,
should not nullify its use as a basis to modify the disclosure of one reference
with the teachings of another. Instead, the benefits, both lost and gained,
should be weighed against one another.” Medichem S.A. v. Rolabo S.L., 437
F.3d 1157, 1165 (Fed. Cir. 2006).
The obviousness rejection of claim 25 is affirmed. Appellants present
similar argument in the Brief for claims 27, 30 and 31, and the rejection of
these claims is affirmed based on the reasoning for claim 25 herein.

CONCLUSION OF LAW
The combined teachings of Hui and Avenia disclose the limitation of
the claims: “providing in combination in a medium, together with the sample
and the antibodies, an enzyme label conjugate of the formula set forth in the
claim having a -(CH2)nC(O) moiety linking the enzyme to the molecule.”

2. Claims 25, 27, 30 and 31 are rejected under 35 U.S.C. §103(a) as being
unpatentable over Rouhani in view of Avenia.
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Appellants present the same arguments for the rejection of Rouhani in
view of Avenia as presented for the rejection of Hui in view of Avenia.
(App. Br. 24.) Similar to Hui, Rouhani discloses an immunoassay for
ecstasy amphetamine derivatives that employs an enzyme that undergoes
change in activity. (Rouhani, 7.) Rouhani discloses immunogens which
generate antibodies that recognize different amphetamine derivatives. (Page
41, Example 7.) Avenia discloses the same immunogen and hapten, and the
same linking group, as claimed which can be substituted by one of ordinary
skill in the art for the immunogen of Rouhani.
Thus, employing the same analysis for the combination of Rouhani
and Avenia as for Hui and Avenia, we affirm the obviousness rejection.
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

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