Ex Parte Ramsey et al

Patent Trial and Appeal Board

Aug 10, 2017

13269365 (P.T.A.B. Aug. 10, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/269,365 10/07/2011 Timothy L. Ramsey SUGE.P0008US 4318
108197 7590 08/14/2017
Parker Highlander PLLC
1120 South Capital of Texas Highway
Bldg. 1, Suite 200
Austin, TX 78746
EXAMINER
GOLDBERG, JEANINE ANNE
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
08/14/2017 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):
docket @ phiplaw .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TIMOTHY L. RAMSEY, BHARAT MEHROTRA,
and MARK D. BRENNAN1
Appeal 2016-000321
Application 13/269,365
Technology Center 1600
Before ERIC B. GRIMES, RICHARD J. SMITH, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a method
of treating a psychotic disorder, which have been rejected as being directed
to patent-ineligible subject matter and as nonenabled. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as SureGene, LLC. (Appeal
Br. 3.)
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STATEMENT OF THE CASE
The Specification discloses a method of treating psychotic disorders
such as schizophrenia. (Spec. 12.) The Specification states that “there are
individual differences in response to specific drugs based on differences in
drug pharmacology and metabolism, combined with genetic differences
between patients. There are currently no proven ways to identify which
antipsychotic drug is optimal for a given patient.” {Id. 14.)
The Specification discloses that “a genetic signature, which the
inventors refer to as the Olanzapine Poor Response Predictor (OPRP), is a
biomarker” that can be used to select an antipsychotic treatment plan. {Id.
16.) “For example, the inventors have discovered that patients that are
OPRP negative respond better than patients that are OPRP positive when
treated with olanzapine, clozapine, or quetiapine.” (Id.)
“Determination of the genotype of SNP [single nucleotide
polymorphism] marker rsl 1960832, which is located within the SV2C gene,
comprises one aspect of the OPRP genetic signature test.” {Id. 163.)
“Determination of the genotype of SNP marker rs7975477, which is located
within the MGAT4C gene, comprises one aspect of the OPRP genetic
signature test.” {Id. 164.)
Claims 1—10 are on appeal. Claim 1 is illustrative and reads as
follows:
1. A method for treating a human subject having or
suspected of having a psychotic disorder, comprising:
a) selecting a subject having or suspected of having a
psychotic disorder and who has been determined to have
the OPRP genetic signature, wherein the OPRP genetic
signature is defined as a genotype comprising a
homozygous genotype for the T allele at rsl 1960832 and
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either a homozygous or heterozygous genotype for the T
allele at rs7975477; and
b) treating the subject that was determined to have the
OPRP signature with an antipsychotic treatment other
than clozapine or quetiapine.
The claims stand rejected as follows:
Claims 1—10 under 35 U.S.C. § 101 as being directed to patent-
ineligible subject matter (Final Action2 3) and
Claims 1—10 under 35 U.S.C. § 112, first paragraph, for lack of
enablement (id. at 9).
I
The Examiner has rejected claims 1—10 as being directed to patent-
ineligible subject matter. The Examiner finds that, under the standard set
out in Mayo Collaborative Services v. Prometheus Labs., Inc., 566 U.S. 66
(2012), “the claims inform a relevant audience about certain laws of nature.
The additional steps consist of well-understood, routine, conventional
activity already engaged in by the scientific community. The additional
steps, when viewed as a whole, add nothing significant beyond the sum of
their parts taken separately.” (Final Action 5.)
Specifically, the Examiner reasons that “[t]he correlation between
whether particular OPRP genetic signature is present and response to
clozapine or quetiapine treatment is considered a Taw of nature’ in
accordance with Mayo.” (Id.) The Examiner concludes that the “selecting”
step of claim 1 is not sufficient to transform the nature of the claim and the
2 Office Action mailed March 4, 2014.
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treatment step did not distinguish the claimed process from Mayo because
the claims in that case were also directed to a method of treatment. {Id. at 6,
9.)
We agree with the Examiner that claim 1 is not eligible for patenting.
In our view, claim 1 falls squarely into the category of inventions that were
held ineligible for patenting by the Mayo Court.
Claim 1 at issue in Mayo was directed to:
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 levels of 6—thioguanine below or above certain thresholds indicate a
need to increase or decrease, respectively, the amount of drug being
administered. Mayo, 566 U.S. at 74.
Similarly, claim 1 of the present appeal is directed to a method of
treating a patient with a psychotic disorder by selecting a patient who has the
OPRP genetic signature and avoiding clozapine and quetiapine based on the
presence of that genotype. In other words, claim 1 is directed to a method of
optimizing therapeutic efficacy for treatment of a psychotic disorder by
choosing the antipsychotic medication to administer based on the presence
of the OPRP genetic signature.
The Mayo Court concluded that “Prometheus’ patents 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.” Mayo, 566 U.S. at 77. Similarly, claim 1 on
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appeal sets forth a law of nature—namely, a relationship between the OPRP
genetic signature and the likelihood that particular antipsychotic drugs will
prove ineffective.
The Mayo Court noted that “[wjhile it takes a human action (the
administration of a thiopurine drug) to trigger a manifestation of this relation
in a particular person, the relation itself exists in principle apart from any
human action.” Id. Similarly here, while it takes a human action
(administration of clozapine or quetiapine) to trigger a manifestation of the
relationship between these drugs and the OPRP genetic signature, the
relationship exists in principle apart from the human action.
The Mayo Court concluded that the “administering” step of the
method claimed in that case “simply refers to the relevant audience, namely
doctors who treat patients with certain diseases with thiopurine drugs.” Id.
at 78. Similarly here, the “selecting” step of claim 1 on appeal simply
directs the audience of doctors who treat patients having psychotic disorders
to a particular subset of those patients.
The Mayo Court concluded that “[ajnyone who wants to make use of
these laws must first administer a thiopurine drug and measure the resulting
metabolite concentrations, and so the combination amounts to nothing
significantly more than an instruction to doctors to apply the applicable laws
when treating their patients.” Id. at 79. Similarly here, anyone who wants to
make use of the natural law—the relationship between the OPRP genetic
signature and the lack of efficacy of clozapine or quetiapine—must first
determine whether a given patient has the OPRP genetic signature before
determining which antipsychotic medication to treat them with. Thus, claim
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1 amounts to nothing significantly more than an instruction to doctors to
apply the applicable law when treating their patients.
In summary, we agree with the Examiner that under the standard set
out in Mayo, claim 1 is directed to patent-ineligible subject matter.
Appellants argue that, under the examination guidelines issued in
December 2014, claim 1 is patent-eligible. (Appeal Br. 5.) Appellants
argue that “the new guidelines specifically identity a new use for an old drug
as an example of patent eligible subject matter.” (Id.)
This argument is unpersuasive. The Specification states that
“‘Typical’ antipsychotics refer to so called first generation or classical
antipsychotics. This class of drug was first developed in the 1950s.” (Spec.
144.) “‘Atypical’ antipsychotics refer to a newer class of antipsychotic
drugs first introduced in the 1990s.” (Id. 145.) The Specification lists
several atypical antipsychotics with FDA approval dates ranging from 1990
to 2006. (Id. H46-52.)
Thus, treatment of schizophrenic patients with antipsychotic drugs
other than clozapine or quetiapine does not represent a new use for the
known antipsychotic drugs. True, the decisions to treat certain patients with
certain drugs was not based on knowing that the patients had the OPRP
genetic signature, but in the method of claim 1 the antipsychotic drugs are
nonetheless administered for their conventional use of treating schizophrenia.
Appellants point to two claims in an example analysis issued by the
USPTO of the patent-eligibility of nature-based products. (Reply Br. 2—3.)
Appellants argue that the exemplary claims “are said to be patent eligible on
the basis that ‘[ajlthough the claim recites a nature-based product (amazonic
acid), analysis of the claim as a whole indicates that the claim is focused on
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a process of practically applying the product to treat a particular disease
(colon cancer), and not on the product per se.[’]” (Id. at 2.) Appellants
argue that claim 1 is directed to treating a disease and therefore should be
patent-eligible. (Mat 3.)
This argument is unpersuasive, because the cited exemplary claims
address analysis of a different class of inventions that have been held to be
patent-ineligible; specifically, products of nature. See Association for
Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013):
In Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127,
68 S.Ct. 440, 92 L.Ed. 588 (1948), this Court considered a
composition patent that claimed a mixture of naturally occurring
strains of bacteria.... His patent claim thus fell squarely within
the law of nature exception. So do Myriad’s. Myriad found the
location of the BRCA1 and BRCA2 genes, but that discovery, by
itself, does not render the BRCA genes “new . . . composition^]
of matter,” § 101, that are patent eligible.
Id. at 2117. In this appeal, by contrast, the issue is whether the method of
claim 1 is effectively directed to a law of nature or a natural phenomenon;
i.e., the relationship between the OPRP genetic signature and lack of
efficacy of clozapine and quetiapine.
Appellants also argue that claim 1
does not foreclose all uses of the underlying natural principal
[sic]. . . . Under the current claims, the only thing foreclosed by
the claim is to use this specific genotype as a means of
identifying responders or non-responders to specific drugs or
classes of drugs. Otherwise, the natural phenomenon is free to
use for any other purpose.
(Appeal Br. 5—6.)
This argument is also unpersuasive, because the claims in Mayo could
have been characterized as foreclosing only the use of specific metabolite
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levels to identify patients who were likely to experience either an ineffective
response or harmful effects. The Mayo Court stated:
The laws of nature at issue here are narrow laws that may
have limited applications, but the patent claims that embody
them nonetheless implicate this concern [i.e., preemption], . . .
[T]hey tie up the doctor’s subsequent treatment decision whether
that treatment does, or does not, change in light of the inference
he has drawn using the correlations. And they threaten to inhibit
the development of more refined treatment recommendations
(like that embodied in Mayo’s test), that combine Prometheus’
correlations with later discovered features of metabolites, human
physiology or individual patient characteristics.
Mayo, 566 U.S. at 86—87.
Appellants also argue that “the use of this particular genotype
indicator for patient responders can in no way be characterized as ‘well-
understood, routine and conventional’ in the field.” (Appeal Br. 6.)
This argument seems to be based on a misreading of Mayo. The issue
in that case was not whether the law of nature itself was well-understood,
routine, and conventional, but whether the claimed method steps added to
the law of nature anything more than well-understood, routine, and
conventional activity. See Mayo, 566 U.S. at 73 (“[T]he steps in the claimed
processes (apart from the natural laws themselves) involve well-understood,
routine, conventional activity previously engaged in by researchers in the
field.”); id. at 79—80 (“[T]he 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.”).
Finally, Appellants argue that the “discovery of the fact that some
patients are more or less sensitive to certain man-made drugs does indeed
‘integrate the natural principle’ and is a ‘meaningful limit on the
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performance of the invention’” and that, “under current USPTO examination
guidelines, ‘method of treatment’ claims that identify a subpopulation of
patients for treatment with a particular drug, such as those of the present
application, are allowable.” (Appeal Br. 6—7.)
This argument is also unpersuasive. For the reasons discussed
previously, we do not agree that the examples cited by Appellants based on
the USPTO’s examination guidelines support patentability of claim 1 on
appeal. In any event, the Supreme Court’s decision in Mayo is controlling
based on the facts of this appeal.
We therefore affirm the rejection of claim 1 under 35 U.S.C. § 101.
Claims 2—10 have not been argued separately and therefore fall with claim 1.
37 C.F.R. §41.37(c)(l)(iv).
II
The Examiner has rejected claims 1—10 as nonenabled, on the basis
that the Specification “does not reasonably provide enablement for
determining which subjects should be administered quetiapine.” (Final
Action 9.) The Examiner finds that Ramsey3 “claims methods that provide
treating subjects with the OPRP signature with quetiapine. This is in
contrast to the instant claims.” {Id. at 11.) The Examiner also finds that,
based on the Specification’s Tables 4 and 5, “it is unpredictable why the
skilled artisan would administer quetiapine to OPRP negative patients and
not OPRP [positive] patients.” {Id. at 12.)
Appellants argue that “Example 6 of the instant application . . . shows
that OPRP positive subjects fare worse than OPRP negative subjects on
3 Ramsey et al., US 7,932,042 Bl, April 26, 2011.
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quetiapine (see Tables 11 and 12 of the instant specification).” (Appeal Br.
7.) Appellants argue that
the data show that OPRP positive subjects respond more poorly
than do OPRP negative subjects to quetiapine. Therefore, as
taught by the instant specification and would be clear to one
skilled in the art, given the choice of quetiapine versus
risperidone or ziprasidone for OPRP positive subjects,
quetiapine should be avoided.
(Id. at 8.)
We agree with Appellants that the Examiner has not pointed to
sufficient evidence to show that practicing the claimed method would
require undue experimentation. The Specification states that, “[a]s can be
seen from Table 11, the OPRP positive group responded worse to clozapine
and to quetiapine than did the OPRP negative group.” (Spec. 1367.) The
Specification also states that “[a]s summarized in Table 12, when Caucasian
patients are segmented by OPRP status and treatment arm, clozapine-treated
or quetiapine-treated OPRP positive subjects demonstrated greater
likelihood of worsening of symptoms . . . than OPRP negative subjects.”
(Id. 1368.)
The Specification expressly states that “patients that are OPRP
negative respond better than patients that are OPRP positive when treated
with olanzapine, clozapine, or quetiapine.” (Id. 1 6.) The Specification
describes numerous typical and atypical antipsychotic medications. (Id.
44—59.) Thus, it would seem that the only experimentation that would be
required to practice the method of claim 1 would be reading genetic
sequence data to identify particular alleles at two SNP positions and
choosing an established antipsychotic medication other than clozapine or
quetiapine. The Examiner has not shown that this amount of
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experimentation would be considered undue. We therefore reverse the
rejection of claims 1—10 for lack of enablement.
SUMMARY
We affirm the rejection of claims 1—10 under 35 U.S.C. § 101.
We reverse the rejection of claims 1—10 under 35 U.S.C. § 112, first
paragraph.
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
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