Ex Parte Grigorieva et al

Patent Trial and Appeal Board

May 17, 2016

12932295 (P.T.A.B. May. 17, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/932,295 02/22/2011 Julia Grigorieva
20306 7590 05/18/2016
MCDONNELL BOEHNEN HULBERT & BERGHOFF LLP
300 S. WACKER DRIVE
32NDFLOOR
CHICAGO, IL 60606
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.
10-095-US 9817
EXAMINER
NEGIN, RUSSELL SCOTT
ART UNIT PAPER NUMBER
1631
MAILDATE DELIVERY MODE
05/18/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JULIA GRIGORIEV A, HEINRICH RODER, and
MAXIM TSYPIN 1
Appeal2016-002530
Application 12/932,295
Technology Center 1600
Before ERIC B. GRIMES, MELANIE L. McCOLLUM, and
JOHN G. NEW, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of predicting whether a cancer patient is likely to benefit from a particular
treatment, which have been rejected under 35 U.S.C. §§ 101 and 103(a), and
for obviousness-type double patenting. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as Biodesix, Inc. (Appeal Br.
1.)
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Application 12/932,295
STATEMENT OF THE CASE
The Specification states "[t]he assignee of the present invention,
Biodesix, Inc, has developed a test known as V eriStrat which predicts
whether Non-Small Cell Lung Cancer (NSCLC) patients are likely or not
likely to benefit from treatment of Epidermal Growth Factor Receptor
(EGFR) pathway targeting drugs." (Spec. 2:16-20.) The VeriStrat test is
based on a serum sample, and "[t]hrough a combination ofMALDI-TOF
mass spectrometry and data analysis algorithms implemented in a computer,
it compares a set of eight integrated peak intensities at predefined m/z ranges
with those from a training cohort." (Id. at 2:25 to 3:1.) The outcome labels
patients as VeriStrat "good" or VeriStrat "poor": "[P]atients, whose pre-
treatment serum/plasma was VeriStrat 'good', have significantly better
outcome when treated with epidermal growth factor receptor inhibitor drugs
than those patients whose sample results in a VeriStrat 'poor' signature."
(Id. at 3:3-6.)
The Specification also states that the VeriStrat test "will predict
differential benefit of [a] solid epithelial tumor cancer patient from therapy
with therapeutic agents or a combination of therapeutic agents targeting
agonists of the receptors, receptors or proteins involved in MAPK pathways
or the PKC upstream from or at Akt or ERK/JNK/p38 or PKC. EGFR
inhibitors are the examples of such agents." (Id. at 5:23 to 6:4.) The
Specification states "these therapeutic agents" (id. at 10:7) also include
"non-steroidal anti-inflammatory drugs (NSAIDs), ... [which] have also
been shown to suppress NF-KB activation," as well as "[o]ther NF-KB
inhibitors" (id. at 11 :3-6).
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Application 12/932,295
Claims 1, 5-7, 9, 10, 15, 16, and 18-27 are on appeal. Claim 1 is
illustrative and reads as follows:
1. A method of identifying a solid epithelial tumor cancer patient as
being likely to benefit from treatment with a therapeutic agent or a
combination of therapeutic agents targeting agonists of the receptors,
receptors or proteins involved in MAPK (mitogen-activated protein kinase),
PI3K, or the PKC (protein kinase C) pathways upstream from or at Akt or
ERK/JNK/p3 8 or PKC or not likely to benefit from treatment with the
therapeutic agent or the combination of therapeutic agents, and whether the
patient is likely to benefit from the treatment with an NF-KB inhibitor
comprising the steps of:
a) conducting mass spectrometry on a blood-based sample from
the solid epithelial tumor cancer patient with a mass-spectrometer and
thereby obtaining a mass spectrum of the blood-based sample; and, with the
aid of a programmed computer:
b) performing one or more predefined pre-processing steps on the
mass spectrum obtained in step a);
c) obtaining integrated intensity values of selected features in said
mass spectrum at one or more predefined m/z ranges after the pre-processing
steps on the mass spectrum in step b) have been performed;
d) executing in the programmed computer a classification
algorithm comparing the integrated intensity values obtained in step c) to
features in a training set comprising class-labeled mass spectra produced
from blood-based samples from other solid epithelial tumor cancer patients
to assign a class label to the patient to identify the patient as being either
likely or not likely to benefit from treatment with the therapeutic agent or a
combination of therapeutic agents and wherein the patient is further
identified as likely to benefit from the treatment with an NF-KB inhibitor.
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The claims stand rejected as follows:
Claims 1, 9, 10, and 18-27 under 35 U.S.C. § 103(a) as obvious based
on Taguchi,2 Chung,3 and Pluenneke4 (Final Rej. 5 5);
Claims 6, 7, 15, and 16 under 35 U.S.C. § 103(a) as obvious based on
Taguchi, Chung, Pluenneke, and Buschmann6 (Final Rej. 11 );
Claims 1, 5-7, 9, 10, 15, 16, and 18-27 under 35 U.S.C. § 101 as
being "directed to a judicial exception (i.e. law of nature, a natural
phenomenon, or an abstract idea) without significantly more" (Final Rej. 3);
and
Claims 1, 9, and 26, provisionally, for obviousness-type double
patenting based on claims 3, 4, and 12 of application 12/806, 137 and
Pluenneke (Final Rej. 15). 7
2 Taguchi et al., Mass Spectrometry to Classify Non-Small-Cell Lung Cancer
Patients for Clinical Outcome After Treatment With Epidermal Growth
Factor Receptor Tyrosine Kinase Inhibitors: A Multicohort Cross-
Institutional Study, 99 J. Natl. Cancer Inst. 838-846 (2007).
3 Chung et al., Detection of Tumor Epidermal Growth Factor Receptor
Pathway Dependence by Serum Mass Spectrometry in Cancer Patients, 19
Cancer Epidemiol. Biomarkers Prev. OF l-OF8 (2010).
4 Pluenneke, US 2004/014728 Al, published July 29, 2004.
5 Office Action mailed Feb. 20, 2015.
6 Buschmann et al., US 2007/0088024 Al, published Apr. 19, 2007.
7 In addition to the above double patenting rejection, the Examiner also
provisionally rejected claims 1 and 9 based on claims 1 and 7 of application
14/295,783 and Pluenneke (Final Rej. 16). USPTO records show that the
'783 application has been abandoned, so this provisional rejection is
dismissed as moot.
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Issue
I
The Examiner has rejected claims 1, 9, 10, and 18-27 as obvious
based on Taguchi, Chung, and Pluenneke. The Examiner has also rejected
claims 6, 7, 15, and 16 as obvious based on Taguchi, Chung, Pluenneke, and
Buschmann. Appellants have waived arguments based on Buschmann (see
Appeal Br. 20), so we will address the§ 103(a) rejections together.
The Examiner finds that Taguchi teaches using mass spectrometry
(MS) to distinguish between patients with non-small cell lung cancer
(NSCLC) who benefit from treatment with an EGFR thymidine kinase
inhibitor (EGFR-TKI) and patients with NSCLC who do not benefit from
treatment with an EGFR-TKI. (Final Rej. 7.) The Examiner finds that
Taguchi teaches "pre-processing of MS data obtained from patient serum
and machine learning classification using training sets of cancer patients
already treated with EGFR-TKis." (Id.) The Examiner finds that Taguchi's
method identifies patients as being in "good" or "poor" subgroups of
patients treated with EGFR-TKis. (Id.)
The Examiner finds that Chung teaches a method similar to that of
Taguchi, applied to head and neck squamous cell carcinoma (HNSCC) and
colorectal cancer (CRC), as well as the limitations added by some dependent
claims. (Id. at 7-8.) The Examiner finds that Pluenneke teaches that
"COX2 inhibitors in combination with EGFR inhibitors yield more
beneficial results than the sole use of EGFR inhibitors" and therefore teaches
"ibuprofen as a type ofNF-Kl3 inhibitor to address cancer." (Id. at 8.)
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The Examiner concludes that it would have been obvious "to modify
the machine learning classification study as applied to NSCLC using EGFR-
TKis of Taguchi et al. and Chung et al. by use of the COX2 inhibitors and
NF-KB inhibitors of Pluenneke wherein the motivation would have been that
COX2 and NF-KB inhibitors provide[] an additional/alternative means of
inhibiting cancer cells." (Id. at 9.)
Appellants contend that, "[w]hile ibuprofen has NF-KB inhibitor
activity, it also has COX-1 and COX-2 inhibitor activity .... Pluenneke
teaches the use of ibuprofen for its COX-2 activity. One of skill in the art
would not be guided to NF-KB inhibitors by a list of COX-2 inhibitors
including ibuprofen, which happens to also have NF-KB inhibitor activity."
(Appeal Br. 15.) Appellants also argue that "nothing in the art suggests at
all that the methods of Taguchi or Chung would work to identify solid
epithelial cancer patients that would [be] likely or not likely to benefit from
a combination of EGFR inhibitors and COX-2 inhibitors." (Id. at 16.)
The issue with respect to the§ 103(a) rejections is whether the cited
references support the Examiner's conclusion that it would have been
obvious to apply Taguchi's method to patients treated with a combination of
an EGFR inhibitor and a COX-2 inhibitor such as ibuprofen.
Findings of Fact
1. Taguchi discloses "a predictive algorithm based on matrix-assisted
laser desorption ionization (MALDI) mass spectrometry (MS) analysis of
pretreatment serum to identify patients who are likely to benefit from
treatment with EGFR TKis." (Taguchi 838, Background.)
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2. EGFR TKis have the properties recited in the preamble of claim 1
and include erlotinib and gefitinib. (Spec. 9: 12 to 10: 13.)
3. Taguchi discloses that "[s]erum collected from NSCLC patients
before treatment with gefitinib or erlotinib were analyzed by MALDI MS."
(Taguchi 838, Methods.)
4. NSCLC is a type of solid epithelial tumor. (Spec. 9:9-10.)
5. Taguchi "applied a suite of preprocessing procedures" (Taguchi
841, left col.), after which "spectra were aligned by using a set of common
peaks (m/z 6434.5, 6632.1, 11686.9, 12864.8, 15131.1, 15871.5, and
28102.5)." (Id.)
6. "Each spectrum was characterized by a set of features. Features
were defined as integrated, background-subtracted, and normalized
intensities over a chosen m/z range containing a peak." (Id.)
7. Taguchi states that "[a]n algorithm to predict outcomes after
treatment with EGFR TKis was developed from a training set of 139
patients." (Id. at 838, Methods.) "The classification algorithm we used is a
straightforward implementation of a k-nearest neighbor (KNN) algorithm."
(Id. at 841, left col.)
8. "Candidate features for the classification algorithm were identified
as differentially expressed m/z values from spectra from patients with rapid
progressive disease (training label 'poor') and from spectra from patients
with long-term stable disease (training label 'good')." (Id. at 841, right col.)
9. Taguchi states that "the classifier identified patients who showed
improved outcomes after EGFR TKI treatment. In one cohort, median
survival of patients in the predicted 'good' and 'poor' groups was 207 and
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92 days, respectively .... In the other cohort, median survivals were 306
versus 107 days." (Id. at 838, Results.)
10. Taguchi concludes that "[t]his MALDI MS algorithm was not
merely prognostic but could classify NSCLC patients for good or poor
outcomes after treatment with EGFR TKis. This algorithm may thus assist
in the pretreatment selection of appropriate subgroups ofNSCLC patients
for treatment with EGFR TKis." (Id. at 838, Conclusion.)
11. Chung discloses that "[p ]retreatment serum or plasma from 230
patients treated with cetuximab, EGFR-TKis, or chemotherapy for
recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) or
colorectal cancer (CRC) were analyzed by mass spectrometry. Each sample
was classified into 'good' or 'poor' groups using VeriStrat." (Chung OFl,
Abstract.)
12. Chung states that "[i]n the EGFR inhibitor-treated cohorts, the
classification predicted survival ... whereas the chemotherapy cohort
showed no survival difference." (Id.)
13. Chung states that "[t]his classification is correlated with tumor
EGFR ligand levels and provides a clinically practical way to identify
patients with diverse cancer types most likely to benefit from EGFR
inhibitors." (Id.)
14. Pluenneke discloses "the use of EGFR inhibitors to treat a variety
of cell proliferative diseases." (Pluenneke ,-i 5.)
15. Pluenneke states that "EGFR can be overexpressed in a number of
cancers, and this overexpression sometimes correlates with poor prognosis.
These conditions include ... melanoma ... lung, breast, head and neck, ...
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renal cell (i.e., kidney) ... [and] gastrointestinal (including pancreatic,
gastric, colorectal) ... cancers." (Id. at ii 59.)
16. Pluenneke states that "combination treatments can be more
effective than therapies using a single therapeutic agent." (Id. at ii 59.)
17. Pluenneke discloses a "method for reducing tumor burden
comprising administering effective amounts of an EGFR inhibitor and a
Cyclooxygenase-2 (COX-2) inhibitor to a patient suffering from an EGFR+
cancer." (Id. at ii 61.)
18. Pluenneke states that appropriate COX-2 inhibitors include
ibuprofen. (Id. at ii 62.)
19. Pluenneke states that "[w]hen a COX-2 inhibitor is used in
combination with an EGFR inhibitor, appropriate doses of either or both
may be lower than doses required when either is used as a single agent."
(Id.)
20. The Specification states that NSAIDs, including ibuprofen, "have
also been shown to suppress NF-KB activation." (Spec. 11 :3-5.)
Analysis
We agree with the Examiner that the cited references support a prima
facie case of obviousness. Taguchi discloses a method meeting all of the
limitations of claim 1 (see FF 1-FF 10) except that it does not assign a class
label that identifies whether a patient is likely or unlikely to benefit from
treatment with an EGFR inhibitor and further identified as likely to benefit
from the treatment with an NF-KB inhibitor.
Pluenneke, however, discloses treating cancer with a combination of
an EGFR inhibitor and a COX-2 inhibitor such as ibuprofen (FFl 7, FF18).
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Pluenneke states that with this combination of active agents "appropriate
doses of either or both may be lower than doses required when either is used
as a single agent" (FF19). Thus, it would have been obvious to modify
Taguchi' s method of identifying cancer patients who are likely to benefit
from treatment with an EGFR inhibitor to include identifying patients who
are likely to benefit from treatment with a combination of an EGFR inhibitor
and ibuprofen, in order to allow effective treatment with lower doses of
active agents.
Appellants acknowledge that "ibuprofen has NF-KB inhibitor activity"
but argue that "Pluenneke teaches the use of ibuprofen for its COX-2
activity. One of skill in the art would not be guided to NF-KB inhibitors by a
list of COX-2 inhibitors including ibuprofen, which happens to also have
NF-KB inhibitor activity." (Appeal Br. 15.)
This argument is not persuasive. Identifying patients who are likely to
benefit from treatment with a combination of an EGFR inhibitor and
ibuprofen meets the claim limitation of identifying patients who are likely to
benefit from treatment with an EGFR inhibitor and an NF-KB inhibitor,
because ibuprofen is an NF-KB inhibitor. The cited references therefore
suggest the relevant limitation.
Appellants also argue that "Pluenneke is limited to teaching treatment
ofEGFR+ cancers with an EGFR inhibitor and a COX2 inhibitor. The
instant invention, however, provides methods of prediction of whether solid
epithelial tumor cancer patients will benefit from the specified treatments
and is not limited to only EGFR+ cancers." (Appeal Br. 16.)
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This argument is also unpersuasive, because Pluenneke discloses that
EGFR+ cancers include melanoma, breast cancer, renal cancer, pancreatic
cancer, and colorectal cancer (FF 15), all of which are included in the
Specification's definition of"solid epithelial tumor" (Spec. 9:9-11).
Appellants argue that "[t]he Office has provided no evidence that
teachings of patient responsiveness to EGFR inhibitors can be predictably
correlated to patient responsiveness to a combination of EGFR inhibitors
and COX2 inhibitors." (Appeal Br. 18.)
This argument is also unpersuasive. Taguchi states that its method
"could classify NSCLC patients for good or poor outcomes after treatment
with EGFR TKis" (FFlO). It would have been reasonable for a skilled
worker to expect that the same algorithm would effectively classify patients
for treatment with an EGFR inhibitor in combination with ibuprofen because
Pluenneke does not disclose that the combination changes the mechanism of
action of the EGFR inhibitor, only that the combination allows use of lower
doses of each of the two drugs (FF 19).
With regard to claims 24-26, Appellants argue that "Taguchi, Chung
and Pluenneke do not teach or suggest methods of identifying a member of a
sub-group of cancer patients who (a) have a worse prognosis as compared to
cancer patients who are not a member of the group, and (b) are predicted to
not benefit from epidermal growth factor receptor targeting drugs." (Appeal
Br. 19.)
We disagree. Taguchi states that its method identifies "good" and
"poor" sub-groups of cancer patients for treatment with an EGFR inhibitor,
and that patients in the "poor" sub-group had survival times that were one-
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half to one-third that of patients in the "good" sub-group (FF9). Taguchi's
method therefore identifies a sub-group of cancer patients who have a worse
prognosis than members who are not a member of the group and who are
predicted not to benefit from EGFR-targeting drugs.
With regard to claim 27, Appellants argue that "[b]reast cancer is a
different disease from those disclosed in Taguchi and Chung and it would
not be expected that the methods outlined in Taguchi or Chung to be
effective in the realm of breast cancer, because of the unpredictability of the
art of prognosis of cancer." (Appeal Br. 20.) Appellants argue that
"[b ]ecause of the biological difference between NSCLC, HNSCC, colorectal
cancer, and breast cancer one of skill in the art could not expect that the
predictions in Taguchi or Chung will work in the same way in the case of
breast cancer." (Id.)
This argument is also unpersuasive. Taguchi discloses a method of
classifying NSCLC patients for good or poor outcomes after treatment with
an EGFR inhibitor (FFlO). Chung discloses that the same method
accurately classifies patients with HNSCC or colorectal cancer (FF 11,
FF12). Chung concludes that "[t]his classification is correlated with tumor
EGFR ligand levels and provides a clinically practical way to identify
patients with diverse cancer types most likely to benefit from EGFR
inhibitors" (FF13). Pluenneke discloses that EGFR is overexpressed in a
number of cancers, including lung cancer, head and neck cancer, colorectal
cancer, and breast cancer (FF15). Based on these disclosures, considered
together, a person of ordinary skill in the art would reasonably have
expected that Taguchi's method would accurately identify the subgroup of
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breast cancer patients who have a worse prognosis and are not likely to
benefit from treatment with an EGFR inhibitor, as required by claim 27.
Conclusion of Law
The cited references support the Examiner's conclusion that it would
have been obvious to apply Taguchi's method to patients treated with a
combination of an EGFR inhibitor and a COX-2 inhibitor such as ibuprofen.
We affirm the rejection of claims 1 and 24-2 7. Claims 9, 10, and 18-
23 have not been argued separately and therefore fall with claim 1.
37 C.F.R. § 41.37(c)(l)(iv). We also affirm the rejection of claims 6, 7, 15,
and 16.
II
The Examiner has rejected all of the claims on appeal under 35 U.S.C.
§ 101 as being directed to patent-ineligible subject matter. The Examiner
finds that "[t]he claim(s) does/do not include additional elements that are
sufficient to amount to significantly more than the judicial exception
because the additional elements to the algorithm pertain to nothing more
than obtaining the data on a mass spectrometer. This rejection has been
made in view of Alice Corporation Pty. Ltd. v. CLS Bank International, et
al." (Final Rej. 3--4.)
Appellants contend that the claims satisfy the first step of the Alice
test because "there is no evidence on the record that the invention, as defined
by the particular claim limitations, is simply some abstract method of 'data
processing and machine learning classification of mass spectral intensity
values pertaining to epithelial cancer' as alleged by the Office." (Appeal Br.
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7.) Appellants also contend that claim 1 recites specific substeps, and
"[t]hese sub-steps are physical process steps performed in a computer, and
data representing a specific training set. They are not abstract ideas." (Id. at
8.)
Appellants contend that the claims satisfy the second step of the Alice
test because "[t]he specific limitations of the instant claims act to narrow,
confine, and otherwise tie down the claim so as not to cover the general
abstract idea of just collecting and analyzing data." (Id. at 12.) More
specifically, Appellants argue that the "claims do not cover all cancer
therapy," and require using a blood-based sample, and "the same algorithm
can be used in different methods." (Id. at 12-13.) Appellants argue that
"the claims do not pre-empt all use of the alleged abstract idea." (Id. at 13.)
We agree with the Examiner that, under the two-step test of Alice,
claim 1 is not directed to patent-eligible subject matter. The Alice Court
stated that "[i]n Mayo Collaborative Services v. Prometheus Laboratories,
Inc., 566 U.S.--, 132 S.Ct. 1289, 182 L.Ed.2d 321 (2012), we set forth a
framework for distinguishing patents that claim laws of nature, natural
phenomena, and abstract ideas from those that claim patent-eligible
applications of those concepts." Alice Corp. Pty. Ltd. v. CLS Bank Int 'l, 134
S. Ct. 2347, 2355 (2014).
The Alice Court described the Mayo test as follows:
First, we determine whether the claims at issue are directed to
one of those patent-ineligible concepts. If so, we then ask,
"[ w ]hat else is there in the claims before us?" To answer that
question, we consider the elements of each claim both
individually and "as an ordered combination" to determine
whether the additional elements "transform the nature of the
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(Id.)
claim" into a patent-eligible application. We have described step
two of this analysis as a search for an "'inventive concept"'-
i. e., an element or combination of elements that is "sufficient to
ensure that the patent in practice amounts to significantly more
than a patent upon the [ineligible concept] itself."
The Mayo court applied its test to claims that are similar to those of
the instant application. In Mayo, the claimed invention was a "method of
optimizing therapeutic efficacy for treatment of an immune-mediated
gastrointestinal disorder" comprising administering a certain class of drug
and then determining the level of 6-thio guanine ( 6-TG) in a patient, where a
level of 6-TG below or above certain amounts indicated a need to increase or
decrease, respectively, the drug dosage. Mayo, 122 S. Ct. at 1295.
Claim 1 of the instant application is similar, in that it is directed to a
method of determining whether a given patient is or is not likely to benefit
from treatment with an EGFR inhibitor (or an EGFR inhibitor combined
with ibuprofen), by analyzing by mass spectrometry a blood-based sample
from the patient and comparing the results to those obtained from a training
set of (previously treated) patients.
The Mayo Court concluded that the claims at issue in that case "set
forth laws of nature-namely, relationships between concentrations of
certain metabolites in the blood and the likelihood that a dosage of a
thiopurine drug will prove ineffective or cause harm." Id. at 1296.
Similarly here, claim 1 on appeal sets forth a law of nature-namely,
a relationship between certain characteristics of mass spectral data in blood-
based samples and the likelihood that treatment with an EGFR inhibitor (or
an EGFR inhibitor combined with ibuprofen) is or is not likely to be
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effective. Under the first step of the Alice/Mayo test claim 1 on appeal is
directed to a law of nature or natural phenomenon.
The Mayo Court next turned to the question "[ w ]hat else is there in
the claims before us?" Id. at 1297. The claims in Mayo included an
"administering" step, a "determining" step, and a "wherein" clause. Id. The
Court concluded that "[t]he upshot is that the three steps simply tell doctors
to gather data from which they may draw an inference in light of the
correlations." Id. at 1298. In other words,
the claims inform a relevant audience about certain laws of
nature; any additional steps consist of well-understood, routine,
conventional activity already engaged in by the scientific
community; and those steps, when viewed as a whole, add
nothing significant beyond the sum of their parts taken
separately.
Id. The Court concluded that "the steps are not sufficient to transform
unpatentable natural correlations into patentable applications of those
regularities." Id.
Like the steps of the claims in Mayo, the manipulative steps of claim 1
on appeal also "consist of well-understood, routine, conventional activity
already engaged in by the scientific community." Id. Each of the steps of
claim 1, in fact, is applied to NSCLC patients in Taguchi. All that claim 1
adds to Taguchi is the application of the same method to a broader set of
patients, and the inference that the mass spectral data can predict, in addition
to efficacy of EGFR inhibitor therapy, "whether the patient is likely to
benefit from the treatment with an NF-KB inhibitor" such as ibuprofen
(claim 1 ) .
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Thus, when claim 1 is considered as an ordered combination, it
informs a relevant audience of certain laws of nature: specifically, that
features of mass spectra from cancer patients with solid epithelial tumors can
be used to distinguish between subgroups who are more likely or less likely
to benefit from treatment with a combination of an EGFR inhibitor and
ibuprofen. All of the additional steps of claim 1 consist of well-understood,
routine, conventional activity already engaged in by the scientific
community such as Taguchi.
We conclude that, under the Alice/Mayo test, claim 1 is directed to
patent-ineligible subject matter. The rejection of claim 1 under 35 U.S.C.
§ 101 is affirmed. Claims 5-7, 9, 10, 15, 16, and 18-27 have not been
argued separately and therefore fall with claim 1. 37 C.F.R.
§ 41.37(c)(l)(iv).
III
The Examiner has provisionally rejected claims 1, 9, and 26 for
obviousness-type double patenting based on claims 3, 4, and 12 of
application 12/806, 137 and Pluenneke. (Final Rej. 15.)
Appellants argue that "U.S. Ser. No. 12/806,137 has not yet been
examined and this application still has rejections other than this 'provisional'
double patenting rejection. The applicant will address this rejection when
one of the two applications has only a provisional double patenting rejection
remaining." (Appeal Br. 21.)
Since Appellants have chosen not to address the merits of the
provisional obviousness-type double patenting rejection at this time, we will
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affirm it. 37 C.F.R. § 41.37(c)(l)(iv) ("The arguments shall explain why the
examiner erred as to each ground of rejection contested by appellant.").
SUMMARY
We affirm all of the rejections on appeal.
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. § l.136(a).
AFFIRMED
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