Ex Parte Pimentel et al

Patent Trial and Appeal Board

Mar 19, 2018

12050736 (P.T.A.B. Mar. 19, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/050,736 03/18/2008
106303 7590 03/21/2018
Nixon Peabody LLP
300 South Grand Avenue, Suite 4100
Los Angeles, CA 90071
FIRST NAMED INVENTOR
Mark Pimentel
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.
065472-999063US20 9224
EXAMINER
WARE, DEBORAH K
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
03/21/2018 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):
lapatentmb@nixonpeabody.com
ipairlink@nixonpeabody.com
slevy@nixonpeabody.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARK PIMENTEL and HENRY C. LIN 1
Appeal 2016-006533
Application 12/050,736
Technology Center 1600
Before JOHN G. NEW, RICHARD J. SMITH, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants state that the real party-in-interest is Cedars-Sinai Medical
Center. App. Br. 3.
Appeal2016-006533
Application 12/050,736
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 1-5, 8-12, and 15-16 as unpatentable
under 35 U.S.C. § 103(a) as being obvious over the combination of Lin et al.
(US 6,805,852 B2, October 19, 2004) ("Lin") in view of Kayar et al. (US
6,328,959 Bl, December 11, 2001) ("Kayar").
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE and enter a NEW GROUND of rejection.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to methods of diagnosing
constipation and constipation-predominant irritable bowel syndrome by
screening for the presence of abnormally high levels of methane and/or
methanogenic organisms in a subject. Abstract.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A method of diagnosing a subject as having
constipation but not diarrhea, comprising:
obtaining a sample from the subject;
analyzing the sample for the presence of methane; and
making a determination that an abnormally elevated level
of methane in the sample as compared to a healthy individual is
indicative of the subject having constipation but not diarrhea.
App. Br. 12.
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Application 12/050,736
ISSUES AND ANALYSES
We are not persuaded that the Examiner's findings and conclusions
establish that Appellants' claims are primafacie unpatentable under 35
U.S.C. § 103(a) as being obvious over the combined cited prior art. We also
enter a new ground of rejection of the claims under 35 U.S.C. § 101. We
address the arguments raised by Appellants below.
A. Rejection of claims 1-5, 8-12, and 15-16 under 35 U.S.C. § 103(a)
Issue
Appellants argue the Examiner erred by failing to consider the
pending claims as a whole and ignoring an important feature of the pending
claims. App. Br. 7.
Analysis
The Examiner finds Lin teaches methods of diagnosing irritable bowel
syndrome ("IBS") in which patients with IBS experience symptoms
comprising constipation. Final Act. 3 (citing Lin Abstr.; col. 1, 11. 39-42,
col. 2, 11. 57---60). The Examiner finds that Lin teaches that, because there
was no known definitive underlying cause for irritable bowel syndrome
("IBS") in the art, treatment of IBS had been primarily directed to treating
its symptoms, including constipation. Id. The Examiner finds Lin teaches
methods comprising: (1) obtaining a sample from a subject; and (2)
analyzing the sample for the presence of methane, and (3) diagnosing an
abnormally elevated level of methane in a sample breath as compared to a
healthy individual as indicating that the subject has constipation or
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Application 12/050,736
constipation-predominant IBS. 2 Id. (citing Lin col. 15, 11. 29, 31-54, 37, 45,
55---60; col. 22, 11. 25--40; Figs. 1, 2). The Examiner further finds that Lin
teaches that methane is one optional measure and, since it is a gas, can be
measured by a breath test using lactulose or other suitable substrates that are
all well known to those of skill in the art. Id. at 3--4.
The Examiner finds Kayar teaches methane production is abnormally
elevated relative to H2 volume in the intestine of patients with IBS. Final
Act 4 (citing col. 4, 11. 40--42). The Examiner finds Kayar also teaches that
about 20% of colonic gas is absorbed through the intestine, into the
bloodstream, and expired in the breath, whereas the rest of the gases exit the
body as flatus. Id. (citing Kayar col. 3, 11. 1-10).
The Examiner concludes that it would have been obvious to one of
ordinary skill in the art to carry out the method of Lin on a sample of flatus,
blood, or saliva as disclosed or suggested by Kayar, because methane would
have been expected to be present in any of these samples of breath, blood,
breath or even saliva because breath would come into contact with the
saliva. Final Act. 4.
Appellants argue that the claims on appeal, taken as a whole, include
the ability to distinguish constipation from diarrhea by measuring the levels
of methane produced in the gut. App. Br. 7. According to Appellants, the
Examiner's conclusion that "constipation can be diagnosed by measuring
methane levels" ignores a feature of the claims that the subject is determined
to have constipation and not diarrhea (or constipation predominant IBS ("C-
2 See independent claim 8
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Application 12/050,736
IBS" and not diarrhea-predominant IBS ("D-IBS")) when an abnormally
elevated methane level is detected. Id. at 7-8. Appellants assert that the
claims do not merely determine whether the subject has constipation (or C-
IBS) without determining whether the subject does not have diarrhea (or D-
IBS). Id. at 8.
We are not persuaded that the Examiner has established a prima facie
case of obviousness over the teachings and suggestions of the prior art. Lin
teaches that: "[b ]ecause there has been no known underlying cause for
IBS, treatment of IBS has been primarily directed to symptoms of pain,
constipation or diarrhea symptoms." Lin col. 2, 11. 57---60. Lin further
teaches that small intestinal bacterial overgrowth ("SIBO") is an underlying
cause of IBS, as well as other conditions such as "fibromyalgia (FM);
chronic fatigue syndrome (CFS); depression; attention deficit/hyperactivity
disorder (ADHD); multiple sclerosis (MS), systemic lupus erythematosus
(SLE) and other autoimmune diseases; and Crohn's disease (CD)." Id. at
col. 13, 11. 16-24.
Lin also teaches that:
A variable fraction of the population fails to exhale appreciable
hydrogen gas during intestinal fermentation of lactulose; the
intestinal microflora of these individuals instead produce more
methane. Consequently, in the event of an initial negative result
for breath hydrogen, or as a precaution, methane and/or carbon
dioxide contents in each breath sample are optionally measured,
as well as hydrogen, or a substrate other than lactulose is
optionally used. Also, acting as a check, the presence of SIBO
is demonstrated by a relative decrease in peak hydrogen
exhalation values for an individual subject after antimicrobial
treatment, in accordance with the present invention, compared to
pretreatment values.
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Application 12/050,736
Lin col. 15, 11. 42-60 (internal references omitted). Lin thus teaches that
elevated levels of methane in a breath sample can indicate SIBO in the
intestine of a patient and can therefore indicate that the individual suffers
from IBS. But the Examiner points to no suggestion or teaching of Lin, nor
can we discern any, that teaches that an elevated level of methane is
indicative of constipation or C-IBS, but not diarrhea or D-IBS, as recited in
the claims. Simply put, Lin fails to distinguish between either diarrhea- or
constipation-related conditions in its teachings or to suggest that methane
production may be elevated in the latter conditions but not the former.
We consequently reverse the Examiner's rejection of the claims on
this ground. Because we find this issue dispositive, we do not reach
Appellants' additional arguments.
B. NEW GROUND of rejection of claims 1 and 8 under 35 U.S.C. § 101
We enter a new ground of rejection. Independent claims 1 and 8 stand
rejected as unpatentable under 35 U.S.C. § 101 as being directed to
nonstatutory subject matter.
Both independent claims 1 and 8 are directed to a method of using the
detection of an abnormally elevated level of methane in a sample taken from
a subject to determine whether the individual suffers from constipation or C-
IBS, but not diarrhea or D-IBS. Both claims 1 and 8 comprise the steps of:
(1) obtaining a sample; (2) analyzing the sample; and (3) making the
determination based upon the results of the analysis.
We find that the steps recited in the claims are directly analogous to
those at issue in Mayo Collaborative Services v. Prometheus Laboratories,
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Inc., 566 U.S. 66 (2012). In Mayo, the claim at issue similarly recited: (1)
obtaining a sample; (2) analyzing the sample; and (3) determining a plan of
treatment based upon the results of that analysis. 3 Mayo, 566 U.S. at 74--75.
The Supreme Court first found that the Mayo claims were directed to a
judicially-created exception to Section 101, viz., a phenomenon of nature.
Id. at 77. Specifically, the Court found that the claims recited 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.
3 The claims of the patent-in-suit of Mayo additionally recited the
administration of a thiopurine compound prior to obtaining the sample. By
way of example, claim 1 of Mayo recited:
A method of optimizing therapeutic efficacy for treatment of an
immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject
having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject
having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about
230 pmol per 8 x 108 red blood cells indicates a need to
increase the amount of said drug subsequently
administered to said subject and
wherein the level of 6-thioguanine greater than
about 400 pmol per 8 x 108 red blood cells indicates a need
to decrease the amount of said drug subsequently
administered to said subject.
Mayo, 566 U.S. at 74--75.
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In the appeal presently before us, we conclude that Appellants' claims
1 and 8 are similarly directed to a phenomenon of nature: viz., the
relationship between constipation or C-IBS, both of which are naturally-
occurring conditions, and the associated production of abnormally elevated
levels of methane in the gut. Having so concluded, and following the
analysis set forth by the Court in Mayo, we are then required to determine
whether the claims "do significantly more than simply describe these natural
relations. To put the matter more precisely, do the patent claims add enough
to their statements of the correlations to allow the processes they describe to
qualify as patent-eligible processes that apply natural laws?" Mayo, 566
U.S. at 77 (emphasis in original).
Following the Supreme Court's analysis in Mayo, we conclude that
they do not. We find that the three recited steps of claims 1 and 8 are
directly analogous to the steps of the claims at issue in Mayo which:
[S]imply tell doctors to gather data from which they may draw
an inference in light of the correlations. To put the matter more
succinctly, 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. For these reasons we believe that the steps are not
sufficient to transform unpatentable natural correlations into
patentable applications of those regularities.
Mayo, 566 U.S. at 79--80.
Neither Appellants' claims nor their Specification recite a novel
manner of obtaining or analyzing the collected samples; instead, the scope of
the claim encompasses any and all methods of obtaining and analyzing the
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Application 12/050,736
collected sample, including those commonly known in the art, and as taught
by Lin and Kayar. See, e.g., Lin col. 15, 11. 50-60; Kayar, col. 6, 11. 53-59.
And, having made such an analysis of the sample, the person performing it is
required to do no more than understand the phenomenon of nature to which
the claim is directed, i.e., that an abnormally elevated level of methane in the
sample is indicative of constipation or C-IBS. As such, we conclude that the
claims are not directed to significantly more than the natural phenomenon
itself and are, consequently, unpatentable.
We therefore enter a new ground of rejection of independent claims 1
and 8 as unpatentable under 35 U.S.C. § 101 as being directed to
nonstatutory subject matter. We leave determination of the patentability of
dependent claims 2-5, 9-12, and 15-16 to the Examiner, subject to further
prosecution.
DECISION
The Examiner's rejection of claims 1-5, 8-12, and 15-16 under 35
U.S.C. § 103(a) is reversed.
We have also entered a new ground of rejection pursuant to 37 C.F.R.
§ 41.50(b) for claims 1 and 8 under 35 U.S.C. § 101.
This Decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides that "[a] new ground of
rejection ... shall not be considered final for judicial review."
37 C.F.R. § 41.50(b) also provides that the Appellants, WITHIN
TWO MONTHS FROM THE DATE OF THE DECISION, must exercise
one of the following two options with respect to the new ground of rejection
to avoid termination of the appeal as to the rejected claims:
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Application 12/050,736
(1) Reopen prosecution. Submit an appropriate amendment of
the claims so rejected or new Evidence relating to the claims so
rejected, or both, and have the matter reconsidered by the
examiner, in which event the proceeding will be remanded to the
exammer ....
(2) Request rehearing. Request that the proceeding be reheard
under § 41.52 by the Board upon the same Record ....
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 )(iv).
REVERSED
37 C.F.R. § 41.50(b)
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