Ex Parte Tuytten et al

Patent Trial and Appeal Board

Jan 30, 2019

13312698 (P.T.A.B. Jan. 30, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/312,698 12/06/2011
20995 7590 02/01/2019
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE, CA 92614
FIRST NAMED INVENTOR
Robin Tuytten
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.
LAUR005.003AUS 1590
EXAMINER
DINES, KARLA A
ART UNIT PAPER NUMBER
1639
NOTIFICATION DATE DELIVERY MODE
02/01/2019 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):
j ayna.cartee@knobbe.com
efiling@knobbe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBIN TUYTTEN, GREGOIRE THOMAS, and
PIET MOERMAN
Appeal 2017-011382
Application 13/312,698 1
Technology Center 1600
Before ROBERT A. POLLOCK, TIMOTHY G. MAJORS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a test
panel comprising five particular specific binding molecules conjugated to an
optical detection agent, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
STATEMENT OF THE CASE
"Hypertensive disorders [including preeclampsia ("PE")] occurring
during pregnancy represent a major cause of maternal morbidity and
1 Appellants identify the real party in interest as MyCartis NV. (Appeal Br.
2.)
Appeal 2017-011382
Application 13/312,698
mortality worldwide, and are also associated with increased perinatal
mortality." (Spec. 1.) "Dependable and early prediction and/or diagnosis is
therefore crucial for successful treatment interventions in hypertensive
disorders of pregnancy including inter alia PE." (Id. at 2.) "The invention
relates to biomarkers and parameters useful for the diagnosis, prediction,
prognosis and/or monitoring of diseases and conditions in subjects," such as
PE. (Id. at 1.)
Claims 9, 18, 20, and 21 are on appeal. Claim 9 is representative and
reads as follows:
9. A test panel comprising IGFALS-specific binding molecule
conjugated to an optical detection agent, SPINTl-specific
binding molecule conjugated to an optical detection agent,
ADAM12-specific binding molecule conjugated to an optical
detection agent, s-Endoglin (ENG ors-ENG) -specific binding
molecule conjugated to an optical detection agent and MUC 18-
specific binding molecule conjugated to an optical detection
agent.
(Appeal Br. 13.)
2
Appeal 2017-011382
Application 13/312,698
The following grounds of rejection by the Examiner are before us on
review:
Claim 9 under 35 U.S.C. § 103 as unpatentable over Wewer, 2
Krizman, 3 Kim, 4 Mori, 5 Lopez-Novoa, 6 and Liu. 7
Claims 18, 20, and 21 under 35 U.S.C. § 103 as unpatentable over
Wewer, Krizman, Kim, Mori, Lopez-Novoa, Liu, and Rayman. 8
Claims 9, 20, and 21 provisionally on the ground ofnonstatutory
double patenting as being unpatentable over claims 1, 4, 10, 11, 14, 15, and
17-19 of copending Application No. 14/363,903.
DISCUSSION
Obviousness
The Examiner finds that W ewer teaches "an array for the
determination of a protein," that "ADAM 12 is used in conjunction with
biometric, serological, or clinical information to derive a risk for developing
2 Wewer et al., US 2006/0134654 Al, published June 22, 2006.
3 Krizman, US 2009/0136971 Al, published May 28, 2009.
4 Kim et al., KR 10-2010-0088217, published Aug. 9, 2010.
5 Mori et al., The Cytotrophoblast Layer of Human Chorionic Villi Becomes
Thinner but Maintains Its Structural Integrity During Gestation, 7 6 Biology
of Reproduction 164--172 (2006).
6 Jose M. Lopez-Novoa, Soluble endoglin is an accurate predictor and a
pathogenic molecule in pre-eclampsia, 22 Nephrology Dial Transplant 712-
714 (2007).
7 Liu et al., Pre-eclampsia is associated with the failure of melanoma cell
adhesion molecule (MCAM/CD 146) expression by intermediate trophoblast,
84 Laboratory Investigation 221-228 (2004).
8 Rayman et al., Low selenium status is associated with the occurrence of
the pregnancy disease preeclampsia in women from the United Kingdom,
189 Am. Journal of Obstetrics and Gynecology 1343-1349 (2003).
3
Appeal 2017-011382
Application 13/312,698
pre[]eclampsia," and that determination of ADAM12 in a sample can be "by
any detection assay known to a person of skill in the art, including
immunoassays and other known arrays." (Final Action 5.) The Examiner
finds that Wewer teaches that ADAM12 serum concentration was reduced in
women who developed preeclampsia and is used in conjunction with
biometric, serological, or clinical information to derive a risk for developing
preeclampsia. (Id.)
The Examiner recognizes that W ewer does not teach an optical
detection agent conjugated to a binding molecule for ADAM12, but notes
that Krizman teaches that "protein array results are usually obtained using
optical detection methods." (Id.) The Examiner concludes that it would
have been obvious to one of ordinary skill in the art to use an optical
detection agent in Wewer for the detection of ADAM12 in light of the
teachings of Krizman. (Id. at 6.)
Regarding the inclusion ofIGFALS, SPINTl, s-Endoglin, and
MUC 18 specific binding molecules, the Examiner finds that the prior art
disclosed each as a biomarker associated with preeclampsia. (Id. at 5; Ans.
13.) In particular, the Examiner notes that Kim teaches IGFALS as a
biomarker related to preeclampsia, Mori teaches SPINTl as a potential
specific marker for preeclampsia; Lopez-Novoa teaches s-Endoglin as a
promising marker to presage preeclampsia, and Liu teaches MUC 18 has a
different pattern of expression in normal pregnancy and in preeclampsia
where it is reduced in placentas as compared to those placentas not
complicated by preeclampsia. (Final Action at 5---6.) The Examiner
concludes that it would have been obvious to combine these biomarkers for
use in a panel of biomarkers to "attain[] better predictability" (Ans. 13),
4
Appeal 2017-011382
Application 13/312,698
"because W ewer et al. teach the use of a biomarker in conjunction with other
biometric, serological, or clinical information to derive a risk for developing
preeclampsia," and "in the interest of operational efficiency, saving time and
resources by testing more than one biomarker at a time" (Final Action 6).
We agree with the Examiner's factual findings and conclusion that it
would have been obvious to combine into a single array the biomarkers
IGFALS, SPINTl, ADAM12, ENG/s-ENG and MUC18 taught by the prior
art, and to have conjugated each to an optical detection agent.
Appellants admit that "the biomarkers IGF ALS, SPINTl, ADAM12,
ENG/s-ENG and MUC18 were taught in the prior art" but contend that "not
all of them were presented as solutions with respect to predicting
preeclampsia" and thus "the art does not teach 'predictable solutions' as
asserted by the Examiner." (Appeal Br. 7; see also Appeal Br. 8-9 ("the
references do not teach that these markers can predictably be used to predict
preeclampsia, either separately or together.").) Appellants note that Wewer
teaches that "ADAM12 serum levels are reduced in the first semester of
Down's syndrome and trisomy 18 pregnancies, as well as in pregnancies that
later developed preeclampsia ([0032]) ... [and its] overexpression correlates
to cancer formation." (Id. at 8) ( emphasis omitted.) Thus, Appellants assert
that Wewer teaches that changes in serum levels of ADAM12 "may be
useful for screening pathologies in pregnant and non-pregnant individuals
([0005])." (Id.) (emphasis omitted.)
Further, Appellants note that while Mori indicates that it would be of
interest to use SPINTl for preeclampsia, "there is no teaching that SPINTl
presence or level is actually correlated to preeclampsia." (Id.) And,
Appellants argue that the remaining references only note "some association
5
Appeal 2017-011382
Application 13/312,698
with the described marker and preeclampsia is disclosed," but do not
indicate that preeclampsia can be predicted using the marker. (Id.)
We do not find Appellants' arguments persuasive because, as the
Examiner explained, the claims are directed to a test panel and not a method
for its use. (Ans. 13.) Thus, the Examiner need not establish the
combination ofbiomarkers would, when tested for, predict preeclampsia.
Appellants do not contest that the 5 biomarkers were known in the art to be
related to preeclampsia. 9 Nor do Appellants contest the Examiner's
assertion (Ans. 16) that it is customary practice in assessing medical
conditions to combine multiple biomarkers and test for their presence. We
conclude in light of the foregoing, that the Examiner has established a reason
to combine the biomarkers into a single test panel, even if they were not yet
established individually to be predictive of preeclampsia. That is, a reason
to combine the biomarkers would be to study their relationship together as
predictors for preeclampsia, or to use them in diagnosing preeclampsia with
9 In their Reply Brief, Appellants contest the Examiner's assertion in the
Examiner's Answer that Appellants admitted the five biomarkers recited in
claim 9 were known in the art to be related to preeclampsia. (Reply Br. 1.)
Appellants quote the paragraph the Examiner relied on, which is as follows:
The Appellant nevertheless submits that, although the biomarkers IGF
ALS, SPINTJ, ADAM12, ENG/s-ENG and MUC18 were taught in the
prior art, not all of them were presented as solutions with respect to
predicting preeclampsia. That is, the art does not teach "predictable
solutions" as asserted by the Examiner.
(Id., quoting Appeal Br. 7.) Appellants explain further: "the markers were
known, but it was not known that these markers could be used to predict
preeclampsia." (Id. at 2 (emphasis added).) We find Appellants' statements
in the Appeal Brief and the Reply Brief to mean that the markers were not
known to "predict preeclampsia," not that they were not known to be related
to preeclampsia.
6
Appeal 2017-011382
Application 13/312,698
better predictability by assessing them in combination. And as the Examiner
explained, operational efficiency of testing more than one biomarker at a
time would have provided a reason to use them together rather than
separately. The Examiner's reasoning applies even though ADAM12 is
associated with other indications in addition to preeclampsia (Appeal Br. 8).
That is because, in combination with other markers associated with
preeclampsia, the presence of ADAM12 would be helpful in confirming
preeclamp sia.
Appellants argue that "simply combining molecules that are
specifically binding to known biomarkers will not necessarily provide a tool
enabling optimal accuracy in the detection of disease." (Appeal Br. 11.)
This argument is not persuasive as the claims do not require optimal
accuracy in detecting preeclampsia. Moreover, 'just because better
alternatives exist in the prior art does not mean that an inferior combination
is inapt for obviousness purposes." In re Mouttet, 686 F.3d 1322, 1334
(Fed. Cir. 2012). Thus, whether combining these markers would result in an
optimal combination is not dispositive of the obviousness question. The
Examiner has provided a prima facie case of obviousness presenting an
objective reason why one of ordinary skill in the art would have combined
these markers in a single test panel.
Appellants further argue that accuracy of the combination of markers
in combination with blood pressure measurement was unexpected (1) with
respect to the prediction of preeclampsia as shown in the tables in the
Specification and (2) that the Declaration of Gregoire Thomas submitted
April 8, 2015 demonstrates "that the combination of markers as claimed is
unexpectedly better than the use of just two markers (blood pressure and
7
Appeal 2017-011382
Application 13/312,698
IGFALS)." (Appeal Br. 9-10.) We note that in both sets of argmnents the
alleged unexpectedly better result is arrived at when the markers are
measured in combination with blood pressure, which is not a recitation of
the claim. Moreover, the unexpected results is in the prediction of preterm
preeclampsia, also not a recitation of the claim. Thus, the arguments of
unexpected results are not persuasive as the showing is not commensurate in
scope with the claims. In re Lindner, 457 F.2d 506, 508 (CCPA 1972)("It is
well established that the objective evidence of nonobviousness must be
commensurate in scope with the claims."
For the reasons discussed, Appellants do not persuade us that the
Examiner erred in maintaining the obviousness rejection of claim 9.
Claims 18, 20, and 21 have not been argued separately. (See Appeal
Br. 11-12 ("Appellant[ s] respectfully submit[] that the dependent claims
incorporate by reference all the limitations of the claim to which they refer
and include their own patentable features, and are therefore in condition for
allowance.") Separately arguing a claim requires "more substantive
arguments in an appeal brief than a mere recitation of the claim elements and
a naked assertion that the corresponding elements were not found in the
prior art." In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011). Claims 18,
20, and 21 fall with claim 9. 37 C.F.R. § 4I.37(c)(l)(iv).
Obviousness-Type Double Patenting
Appellants do not contest the provisional obviousness-type double
patenting rejection. (Appeal Br. 12.) Therefore, we summarily affirm that
rejection.
8
Appeal 2017-011382
Application 13/312,698
SUMMARY
We affirm the rejection of claim 9 under 35 U.S.C. § 103 as
unpatentable over Wewer, Krizman, Kim, Mori, Lopez-Novoa, and Liu.
We affirm the rejection of claims 18, 20, and 21 under 35 U.S.C.
§ 103 as unpatentable over Wewer, Krizman, Kim, Mori, Lopez-Novoa, Liu,
and Rayman.
We affirm the provisional rejection of claims 9, 20, and 21 on the
ground of nonstatutory double patenting as being unpatentable over claims
1, 4, 10, 11, 14, 15, and 17-19 of copending Application No. 14/363,903.
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
9