Ex Parte Lewisch et al

Patent Trial and Appeal Board

Jun 5, 2018

12860600 (P.T.A.B. Jun. 5, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/860,600 08/20/2010
28524 7590 06/07/2018
SIEMENS CORPORATION
INTELLECTUAL PROPERTY DEPARTMENT
3501 Quadrangle Blvd Ste 230
Orlando, FL 32817
FIRST NAMED INVENTOR
Sandra A. Lewisch
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.
2010P06814US 1358
EXAMINER
FOSTER, CHRISTINE E
ART UNIT PAPER NUMBER
1677
NOTIFICATION DATE DELIVERY MODE
06/07/2018 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):
ipdadmin.us@siemens.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SANDRA A. LEWISCH, LYNN M. SCHIAVONI, and
WILLIAM D. BEDZYK
Appeal2017-006543
Application 12/860,600 1
Technology Center 1600
Before DONALD E. ADAMS, ELIZABETH A. LA VIER,
and DAVID COTTA, Administrative Patent Judges.
LA VIER, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants seek review of the
Examiner's rejections of claims 12 and 14--17. We have jurisdiction under
35 U.S.C. § 6(b ). For the reasons set forth below, we REVERSE.
BACKGROUND
The Specification generally relates to methods "for determining an
analyte in a sample suspected of containing the analyte." Spec. i-f 4. For
claim 12, the only independent claim on appeal, the analyte is cortisol:
1 Appellants state the real party in interest is Siemens Healthcare Diagnostics
Inc. Br. 2.
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Application 12/860,600
12. A method for determining an amount of cortisol in a
sample suspected of containing cortisol and different interfering
substances, the method consisting essentially of:
(a) combining in an aqueous medium:
(i) the sample, and
(ii) two or more different antibody-tracer conjugates
wherein the tracer of each different conjugate is the same
and wherein the antibody of each different conjugate is
different and wherein each different antibody binds to at
least two different epitopic sites wherein one of the
epitopic sites is a binding site of cortisol that is a
common binding site bound by all of the antibodies, and
another of the epitopic sites is a binding site of one or
more of the interfering substances that is a non-common
binding site that is different for each different antibody
and wherein each different antibody of the antibody-
tracer conjugates is preselected for its binding profile to
cortisol and to one or more of the interfering substances
and wherein each different antibody exhibits a binding
affinity to a portion of the interfering substances wherein
the portion of interfering substances comprises about
10% to about 90% of the total number of interfering
substances in a sample and wherein the number of
interfering substances in one portion that have low
binding affinity for two different antibodies is no greater
than about 10 and wherein low binding affinity means
that an interfering substance has a binding affinity for
one of the antibodies that is no greater than about 80% of
the binding affinity of cortisol for said one of the
antibodies,
(b) incubating the medium under conditions for binding of the
different antibodies to the epitopic sites,
( c) examining the medium for an amount of signal from the
complexes comprising the epitopic sites and the antibody-tracer
conjugates, and
( d) comparing the amount of the signal to a calibration curve to
determine the true amount of cortisol in the sample,
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Application 12/860,600
wherein the interfering substances are selected from the group
consisting of aldosterone, allotetrahydrocortisol, corticosterone,
cortisone, a-cortol, B-cortol, a-cortolone, B-cortolone,
dehydrocorticosterone, 11-deoxycorticosterone, 11-
deoxycortisol, 21-deoxycortisol, 21-deoxycortisone,
dexamethasone, 5B-dihydrocortisol, 20a-dihydrocortisol, 20B-
dihydrocortisol, 20a-dihydrocortisone, 20B-dihydrocortisone,
fluorocortisone acetate, 6B-hydroxycortisol, 11 B-hydroxy-
etiocholanolone, 17B-hydroxypregnenolone, 17 a-
hydroxyprogesterone, 11 B-hydroxyprogesterone, 11-
ketoetiocholanolone, 6-methyl-prednisolone, prednisolone,
prednisone, progesterone, sulphate 21-cortisol,
tetrahydrocortisol, tetrahydrocortisone, and tetrahydro-11-
deoxycortiso 1.
Br. 21 (Claims Appendix) (emphasis added).
Love, 2 one of the prior art references relied upon by the Examiner,
explains that abnormal cortisol levels are associated with various diseases,
and that cortisol and its analogs are administered therapeutically. Love i-f 3.
Thus, "monitoring of cortisol levels is critical in a number of clinical
situations." Id. However, accurately measuring a patient's cortisol levels
can be challenging:
Cortisol belongs to a class of corticosteroids that are
structurally very similar. Accordingly, immunoassays for
cortisol are subject to interference from cross-reacting
substances .... The result of cross-reactivity in immunoassays
can result in severe miscalculations of substrate concentrations
that can lead to incorrect clinical decisions.
Id. i-f 4.
2 Love et al., US 2009/0005267 Al, published Jan. 1, 2009.
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Appeal2017-006543
Application 12/860,600
REJECTIONS MAINTAINED ON APPEAL
1. Claims 12, 14, 15, and 17 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Love and Reddy. 3 Ans. 2.
2. Claim 16 stands rejected under 35 U.S.C. § 103(a) as unpatentable over
Love, Reddy, and Miller. 4 Ans. 11.
DISCUSSION
As stated above, claim 12 requires "combining in an aqueous
medium" the sample and two (or more) different antibody-tracer conjugates.
The Examiner interprets this to "encompass situations (as in Love et al.) in
which different antibodies on a single support slide are contacted with test
sample and aqueous buffer." Final Action 14--15. We agree with
Appellants, however (see e.g., Br. 7-8 (discussing Love i-fi-1376-378)), that
the microarray embodiments of Love, in which different antibodies attached
to different individual microwells, cannot reasonably be considered to be
"combine[ d] in an aqueous medium" with one another.
Using technical dictionaries as our guide, "aqueous" is defined as
" [ d] escribing a solution in water," 5 and "medium" as "the continuum in
which particular chemical entities and their reactions are studied, commonly
the solvent together with any nonreacting solutes."6 These definitions of
3 Reddy et al., US 7,229,763 B2, issued June 12, 2007.
4 Miller et al., US 7,141,378 B2, issued Nov. 28, 2006.
5 Aqueous, A DICTIONARY OF CHEMISTRY, (Richard Rinnie ed., Oxford Univ.
Press) (7th ed. 2016).
6 Medium (definition 2), OXFORD DICTIONARY OF BIOCHEM. & MOLECULAR
BIO., (Richard Cammack et al., eds., Oxford Univ. Press) (2nd ed. 2006).
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Appeal2017-006543
Application 12/860,600
both "aqueous" and "medium" point to a water-based continuum, which is
consistent with the description provided in the Specification: "[t]he aqueous
medium may be solely water or may include from 0.1 to about 40 volume
percent of a cosolvent such as, for example, a water miscible organic
solvent, e.g., an alcohol, an ether or an amide." Spec. ,-r 44. As to further
components of this water-based continuum, claim 12 states unequivocally
that it is the "sample" and the "two or more different antibody-tracer
conjugates" that must be "combin[ ed] in" this aqueous medium.
In contrast, the antibodies immobilized on Love's microarrays may
contact the aqueous medium applied thereto, but are not combined in it,
insofar as they are not mixed with it because they remain fixed to the
microarray. To read "combining in an aqueous medium" otherwise requires
straining at least one of "aqueous," "medium," "combining in," or "and"
beyond reasonable bounds. Indeed, were we to read claim 12 as broadly as
the Examiner has, a test tube holding a solution also could be said to be "in"
that solution.
When "combining in an aqueous medium" as recited in claim 12 is
understood as requiring the sample and the two or more different antibody-
tracer conjugates to be mixed together in a water-based solution, the
Examiner's rejections cannot be sustained on this record. This is because
the Examiner's rationale for combining Love and Reddy relates solely to the
microarray embodiments of Love, in which the antibodies are affixed to a
solid phase:
Therefore, it would have been obvious to one of ordinary
skill in the art to modify the immunoassay methods of Love et
al. by attaching the different antibodies to the solid phase using
the complementary oligonucleotide-tagging approach of Reddy
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Application 12/860,600
et al., in order to provide a means of quality control
standardization, and greater precision when performing the
detection methods of Love et al. In particular, it would have
been obvious to tag the multiple antibodies of Love et al. with
labeled oligonucleotides (i.e., so as to create antibody-tracer
conjugates) in which all the labels are the same as taught by
Reddy et al. in order to achieve the numerous advantages of this
oligonucleotide-tagging approach outlined by Reddy et al., for
example to allow for standardization of the assay data via the
label, as well as to allow for a non-random means of attaching
the antibodies to the solid phase.
Final Action 11 (emphases added); see also Ans. 18-19. Likewise, the
Examiner relies on Reddy as teaching "additional labeling of the antibodies
immobilized on the solid phase." Ans. 19; see also Final Action 10-11. 7
In sum, because the antibodies affixed to Love's microarrays are not
"combin[ed] in an aqueous medium" with the sample, Love's microarray
embodiments cannot serve as a foundation for the obviousness rejections.
CONCLUSION
The rejections of claims 12 and 14--17 under 35 U.S.C. § 103(a) are
reversed.
REVERSED
7 Although Love also discloses an embodiment in which "the contacting step
is performed in a buffered solution" (Love i-f 182), neither Appellants (in the
Appeal Brief) nor the Examiner (in the Answer or the Final Rejection) appears
to directly discuss this disclosure in Love. Consequently, we do not further
analyze it.
6