Ex Parte Van Criekinge et al

Patent Trial and Appeal Board

Sep 22, 2016

12303153 (P.T.A.B. Sep. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/303, 153 08/25/2009 Wim Van Criekinge
50828 7590 09/26/2016
DAVIDS, RESNICK
NIXON PEABODY LLP
100 SUMMER STREET
BOSTON, MA 02110-2131
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.
740150-078450-us 3136
EXAMINER
BROWN, MINDY G
ART UNIT PAPER NUMBER
1636
NOTIFICATION DATE DELIVERY MODE
09/26/2016 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):
bostonpatent@nixonpeabody.com
ipairlink@nixonpeabody.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WIM VAN, GERRIT MEIJER, JOSEF STRAUB, and
BEATRIZ PINTO MORAIS DE CARVALH0 1
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Application 12/303, 153
Technology Center 1600
Before JOHN G. NEW, ZHENYU YANG, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants state the real party-in-interest is MDX Health Organization.
App. Br. 3.
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Application 12/303, 153
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner's Non-Final Rejection of claims 1-12, 16-36, and 62----672 as
unpatentable under 35 U.S.C. § 101 as being directed to unpatentable subject
matter.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
REPRESENTATIVE CLAIM
Appellants argue all of the pending claims together. App. Br. 10.
Claim 1 is representative of the claims on appeal and recites:
1. A method comprising:
(a) performing an assay on a test sample containing
colorectal cells or nucleic acids from colorectal cells from
a subject with adenoma, wherein the assay assesses if
epigenetic silencing of at least one gene selected from the
group consisting of NM_145059.1, NM_183244.1,
NM_145341.2, NM_080672.3, NM_002630,
NM_003383, NM_005504, NM_016269, NM_006988,
NM_021637, NM_001888, NM 014899 NM_145341,
NM_OOl 752, NM_014142, NM_Ol 145, NM_016013,
NM_Ol 7590, NM_152429, NM_138340, NM_052968,
NM_183244,NM_199423, NM_015111, NM_002181,
NM_005637 ,NM_030790, NM_Ol8144, NM_004232,
NM_030912, NM_145059, NM_033338, NM_006834,
NM_003014, NM_ 001343, NM_ 000963, NM_ 004385,
and NM_ 002899 has occurred;
2 Claims 13-15, 37----61, and 68-75 are canceled. App. Br. 19-23.
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Application 12/303, 153
App. Br. 18.
(b) identifying the subject with adenoma as needing
colorectal cancer treatment where the assay detected
epigenetic silencing in step (a); and
( c) selecting an appropriate therapeutic-treatment strategy
for the subject with adenoma identified in step (b) when
epigenetic silencing of at least one gene from step (a) is
detected, wherein selecting the appropriate therapeutic
treatment strategy comprises administering a treatment
regime is selected from the group consisting of:
endoscopic polypectomy or resection, chemotherapy, and
radiation.
ISSUES AND ANALYSES
We agree with, and adopt, the Examiner's findings and conclusion
that the appealed claims are directed to unpatentable subject matter. We
address the arguments raised by 1A .. ppellants on appeal belov,r.
Issue
Appellants argue the Examiner erred in finding the claims are not
directed to patentable subject matter. App. Br. 9.
Analysis
Appellants dispute the Examiner's conclusion that the claims recite a
phenomenon of nature, routine steps to detect the phenomenon, and routine
treatment steps for a population that has been identified as needing
colorectal cancer treatment as a result of the phenomenon. App. Br. 9
(citing Advisory Act., May 1, 2014). According to Appellants, the
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Examiner erred in focusing only on whether the recited steps are routine,
rather than inquiring whether the claim uses the "exception" in a process
designed to solve a technological problem of conventional industry practice.
Id. at 10 (citing Alice Corp. Pty. Ltd. v. CLS Bankint'l, 134 S.Ct. 2347,
2358 (2014)).
With reference to the claims on appeal, Appellants argue that a skilled
artisan would have known that there is a major problem that the present
claims solve, viz., the difficulty in identifying and treating early stage colon
cancer. App. Br. 11. According to Appellants, the claims require a group of
individuals that are not known to have colon cancer, but who are known to
have an adenoma, a benign tumor. Id. Appellants argue the claims recite
performing an assay on colorectal cells taken from the adenoma patient and,
if epigenetic silencing is detected in at least one gene from a specified group
of thirty-eight, that individual is treated for colon cancer using a defined set
of possible colon cancer treatments. Id. Appellants argue this claimed
method is neither routine nor conventional, but rather solves a significant
problem by providing early identification of a need for treatment in a group
of individuals who had not been identified as having colon cancer. Id. at
11-12.
Appellants also argue that the Examiner has not adequately
considered the majority of the factors set forth in the 2014 Procedure for
Subject Matter Eligibility Analysis of Claims Reciting or Involving Laws of
Nature/Natural Principles, Natural Phenomena, and/or Natural Products.
(March 14, 2014). We have reviewed Appellants' analysis of these factors,
but we find them neither persuasive nor properly reflective of the current
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law or the USPTO's analysis protocols on subject matter eligibility as set
forth by the Director in the 2014 Interim Guidance on Patent Subject Matter
Eligibility, December 10, 2014, and subsequently updated in 2015 and 2016
(the "Interim Guidance").
As an initial matter, we agree with the Examiner that the limitations of
the claims on appeal, as exemplified by claim 1, are analogous to the claims
at issue in Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S.Ct.
1289 (2012) and, consequently, dictate the same outcome. See Ans. 5. We
acknowledge that Alice Corp. holds that the test set forth in Mayo applies to
all tests for subject-matter eligibility. But it is the facts of Mayo that are
more informative with respect to the instant appeal because the instant
claims, like Mayo, but unlike Alice Corp., are directed to a phenomenon of
nature. See Mayo, 32 S.Ct. at 1290-91. Specifically, the instant claims are
directed to the epigenetic silencing of the recited genes, which Appellants do
not dispute is a phenomenon of nature, i.e., it occurs naturally in the body.
As in Mayo, the claims require an assay to detect the phenomenon and a
treatment based upon the outcome of that assay. Id. at 1290. Appellants do
not dispute that the assay or the cancer treatment protocols are not separately
novel, but are well known in the art.
Consequently, we apply the two-part test set forth in the Interim
Guidance for claims involving phenomenon of nature. See Interim Guidance
9-25; 35-37. First, we determine whether the claims on appeal are directed
to a statutory category. In this instance, we conclude that they are: the
claims are directed to a method or process. Next, we determine whether the
claims are directed to a judicially-created exception, in this instance, a
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natural law or phenomenon of nature. Although the claims require a non-
novel assay to determine the phenomenon, the phenomenon itself, epigenetic
silencing of the recite genes, occurs naturally in cancerous and precancerous
cells. See Spec. i-fi-1 4--11. Consequently we find that the claims are directed
to a phenomenon of nature and there falls within one of the judicially-
created exceptions.
Having determined that the claims are directed to a phenomenon of
nature, we next look to the claim as a whole to determine whether any
element, or combination of elements, is sufficient to ensure that the claim
amounts to significantly more than the exception. See Interim Guidance 36.
The "assay" step refers to the activities of the relevant audience, viz.,
physicians who treat patients with cancers of the gastrointestinal tract. The
claims direct these physicians to the recited genes which, when silenced, are
known in the art to be associated with colorectal carcinomas. See Spec. i-fi-1
4--11. The audience is a pre-existing audience and is certainly well
established, moreover, the assays recited in the claims are well known in the
art and can be routinely performed. Id. The "identifying" step tells the
doctor to determine whether certain genes, specified in the claim, have been
silenced. Finally, the "selecting" step instructs the treating physician to treat
the patient with a "treatment regime [ ... ] selected from the group consisting
of: endoscopic polypectomy or resection, chemotherapy, and radiation."
Appellants do not dispute that all of these treatment regimes are well known
and conventional in the art of treating colorectal cancers.
As in Mayo, the claims inform a relevant audience about a certain
phenomenon of nature (specifically here, a correlation between the silencing
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of certain genes in cells and whether those cells are cancerous or pre-
cancerous), and the additional steps of the claims consist merely of "well
understood, routine, conventional activity already engaged in by the
scientific community." Mayo, 32 S.Ct. at 1298. These steps, when viewed
as a whole, add nothing significant beyond the sum of their parts taken
separately. The claims therefore do not amount to significantly more than
the natural law itself and we consequently affirm the Examiner's rejection.
We also recognize, but find unpersuasive, Appellants' contention that
certain dependent claims do more than merely apply the exception (law of
nature). Whether the claims recite detection in 3 8 or 12 genes as in claim 1
and 4, respectively, or in combinations of fewer genes (as in claims 64 or
65), the claims remain directed to a patent-ineligible phenomenon of nature
- the association between colorectal cancer and epigenetic silencing of
certain genes. Further, the application of well-known, routine, and
conventional cancer treatments such as surgery, chemotherapy, or radiation
(as in claims 10, 11, and 12) does not sufficiently transform "unpatentable
natural correlations into patentable applications of those regularities."
Mayo, 132 S.Ct. at 1298.
DECISION
The Examiner's rejection of claims 1-12, 16-36, and 62----67 as
unpatentable under 35 U.S.C. § 101 is affirmed.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
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