Ex Parte Cassidy

Patent Trial and Appeal Board

Dec 22, 2015

11767241 (P.T.A.B. Dec. 22, 2015)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111767,241 06/22/2007 Pamela McDonald Cassidy
22862 7590 12/24/2015
GLENN PATENT GROUP
c/o Perkins Coie LLP
P.O. Box 1247
Seattle, WA 98111-1247
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.
110573-8002.USOl 1924
EXAMINER
POHNERT, STEVEN C
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
12/24/2015 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):
patentprocurement@perkinscoie.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PAMELA McDONALD CASSIDY
Appeal2013-007813
Application 11/767,241
Technology Center 1600
Before ULRIKE W. JENKS, JOHN G. NEW, and RICHARD J. SMITH,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
Appeal2013-007813
Application 13/767,241
SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 1, 11, and 21-24 as unpatentable under
35 U.S.C. § 101 as being directed to non-statutory subject matter. 1' 2
We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellant's invention is directed to a nutritional plan based on a
person's individual APO E genotype. 3 The APO E genotype has been
shown to be the number one gene affecting diet, cholesterol, heart disease,
vascular dementia, Alzheimer's disease, and chronic illness, possibly autism,
Parkinson's disease, and other neurological diseases. The claimed plan
focuses on the right percentages of macronutrients for each individual's
genetic type. Abstract.
REPRESENTATIVE CLAIM
Appellant argues all of the claims together. App. Br. 20. Claim 1 is
representative of the claims on appeal, and recites:
1 Claims 2-10 and 11-20 are canceled. App. Br. 28, 30.
2 Claims 1, 11, and 21-24 were also rejected as unpatentable under
35 U.S.C. § 112, first paragraph for failure to comply with the written
description requirement. See App. Br. 15. That rejection has been
withdrawn by the Examiner. Ans. 6.
3 We note in passing that, although Appellant and Examiner both employ the
claim term "genotype," the subject matter of the claims is more properly the
phenotype, because it is the APO E protein that is expressed by an individual
that is determined in the recited method.
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Application 13/767,241
1. A method for prescribing a nutritional and exercise
regime based upon genotype, comprising the steps of:
an individual submitting a blood sample for testing to
determine the individual's apolipoprotein E (APO E) genotype;
analyzing said blood sample to determine the individual's
apolipoprotein E (APO E) genotype; and
based upon said individual's APO E genotype,
prescribing a genotype specific nutritional regime establishing
dietary levels of:
fat content (long term fuel) with a correct type of
fats for said genotype selected from among inflammatory
fats, comprising fats that come mainly from saturated and
trans fat sources, and anti-inflammatory fats, comprising
fats that come mainly from monounsaturated and
polyunsaturated sources;
prescribing a ratio of fat content to carbohydrate content
based upon said individual's APO E genotype, said ratio
compnsmg:
for APO E 2/2, about 35% fat content, 15% protein
content, and 50% carbohydrate content;
for APO E 2/3, about 30% fat content, 15% protein
content, and 55% carbohydrate content;
for APO E 3/3 and APO E 2/4, about 25% fat
content, 20% protein content, and 55% carbohydrate
content; and
for APO E 3/4 and APO E 4/4, about 20% fat
content, 25% protein content, and 55% carbohydrate
content;
carbohydrate content (short term fuel) with a
correct type of carbohydrates for said genotype selected
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Application 13/767,241
from among carbohydrates having various glycemic
loads, and
protein content with a correct type of proteins for
said genotype selected from among proteins coming from
plant sources and proteins coming from fish and other
animal sources;
based upon said individual's APO E genotype,
prescribing a genotype specific level of caloric content for said
individual; and
based upon said individual's APO E genotype,
prescribing a genotype specific exercise regime to maintain a
percentage of body fat mass and lean mass, based on said
individual's height and weight, said specific exercise regime
compnsmg:
for APO E 2/2 and APO E 2/3, about 45% aerobic
exercise and 55% anaerobic exercise;
for APO E 3/3 and APO E 2/4, about 50% aerobic
exercise and 50% anaerobic exercise; and
for APO E 3/4 and APO E 4/4, about 75% aerobic
exercise and 25% anaerobic exercise;
said specific percentage of body fat mass, based on said
individual's height and weight, comprising for males:
for APO E 2/2 and APO E 2/3, less than 16% body
fat mass, with normal lean mass range based on height;
for APO E 3/3 and APO E 2/4, less than 16% body
fat mass, with lean mass range based on height; and
for APO E 3/4 and APO E 4/4, less than 16% body
fat mass, with lean mass range based on height; and
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Application 13/767,241
said specific percentage of body fat mass, based on said
individual's height and weight, comprising for females:
for APO E 2/2 and APO E 2/3, less than 22% body
fat mass, with normal lean mass range based on height;
for APO E 3/3 and APO E 2/4, less than 22% body
fat mass, with normal lean mass range based on height;
and
for APO E 3/4 and APO E 4/4, less than 22% body
fat mass, with normal lean mass range based on height.
App. Br. 26-27.
ISSUE
Appellant argues the Examiner erred in finding the claims are directed
to non-statutory subject matter. App. Br. 14.
ANALYSIS
Appellant argues that prescribing a diet and exercise plan based on a
person's genotype is neither an abstract idea nor a law or phenomenon of
nature and is therefore patentable subject matter. App. Br. 20. According to
Appellant, even if the discovery that individuals with different versions of
the APO E gene handle foods and chemistry differently can be considered a
phenomenon of nature, Appellant is not claiming the discovery itself. Id.
Appellant contends the claims recite an application of a law of nature to a
process that deserves patent protection, and not merely the law of nature
itself, as asserted by the Examiner. Id. at 21.
Appellant further contends a prescription for diet and exercise that is
based at least on APO E genotype, height, weight, percentage fat body mass,
and percentage lean body mass is not a predictable result derived directly
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Application 13/767,241
from the insight of the function of APO E genotypes. App. Br. 22.
Appellant attests that much experimentation was conducted over a long
period of time to determine how this insight could be used to optimize
health. Id. In addition, Appellant argues, the research was directed toward
customizing the prescription for an individual person, taking into account
more than just the individual's genotype. Id. Furthermore, argues
Appellant, the diet and exercise prescription is not a mere statement of a
concept, but rather implements a concept in a tangible manner; and the
performance of steps is observable and verifiable in a manner similar to a
pharmacological invention. Id.
The Examiner responds that the process described in the claim does
not require a physical transformation, but can be considered rather as a
mental step. Ans. 6. The Examiner also finds the prescriptions set forth for
body composition are dependent upon the sex of the individual: the body
compositions for all APO E genotypes for all males are identical, as are the
prescribed compositions for all women. Id. Furthermore, the Examiner
finds, the diet and exercise prescription are not specific because the use of
the claim term "about" is not specific enough to define the scope of the
claim. Id.
With respect to the first finding, the Examiner finds the exercise
prescription encompasses a mental process or the suggestion of a human
behavior. Ans. 9. The Examiner finds prescribing an exercise prescription
does not actually require any activity or transformation from any subject, as
is demonstrated by the government, doctors, or health care professionals
prescribing that all Americans get 2.5 hours of exercise a week and eat a
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balanced diet, but only a small portion of the population follows the exercise
and diet prescription, as evidenced by the high incidence of obesity. Id.
With respect to the gender-identical prescriptions for body
composition, the Examiner finds the claims provide no limitations that are
dependent on both APO E genotype and body composition. Ans. 8. The
Examiner finds the claims merely set forth general prescriptions (in view of
"about" language) for diet and exercise and prescribe the same body
composition for all males (or females) regardless of APO E genotype. Id. at
8-9. The Examiner finds the claims merely generally prescribe exercise and
diet programs, but do not require the prescription be carried out. Id. at 9.
Finally, with respect to the claim language, the Examiner points, by
way of example, to the language of claim 1 reciting:
[F]or APO E 2/2, about 35% fat content, 15% protein content,
and 50% carbohydrate content; for APO E 2/3, about 30% fat
content, 15% protein content, and 55% carbohydrate content;
for APO E 3/3 and APO E 2/4, about 25% fat content, 20%
protein content, and 55% carbohydrate content; and for APO E
3/4 and APO E 4/4, about 20% fat content, 25% protein
content, and 55% carbohydrate content.
[F]or APO E 2/2 and APO E 2/3, about 45% aerobic exercise
and 55% anaerobic exercise; for APO E 3/3 and APO E 2/4,
about 50% aerobic exercise and 50% anaerobic exercise; and
for APO E 3/4 and APO E 4/4, about 75% aerobic exercise and
25% anaerobic exercise.
Ans. 7-8. The Examiner finds the employment of claim term "about" in the
diet and exercise prescription sections suggest that the prescriptions are not
specific, but rather indicate general parameters that, under the broadest
reasonable interpretation, would overlap. Id. at 8.
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We are not persuaded by Appellant's reasoning. In determining
whether a claim is directed to non-statutory subject matter, we are guided by
the USPTO's 2014 Interim Guidance on Patent Subject Matter Eligibility,
79 (241) Federal Register 74618 (Tuesday, December 16, 2014) (the
"Interim Guidance") (and the July 2015 Update on Subject Matter
Eligibility, available at http://www.uspto.gov/sites/default/files/documents
/ieg-july-2015-update.pdf), which is, in tum, guided by the U.S. Supreme
Court's decisions in Alice Corp. Pty. Ltd. v. CLS Bank Int 'l, 134 S.Ct. 2347
(2014), Association for Molecular Pathology v. Myriad Genetics, Inc., 133
S.Ct. 2107 (2013), and Mayo Collaborative Serv. v. Prometheus Labs., Inc.,
132 S.Ct. 1289 (2012). The Interim Guidance sets forth a two-part test to be
employed in determining whether a claim is directed to statutory patent
matter. Interim Guidance, 79 FR at 7 4621. In the first step, we determine
whether the claim is "directed to one of the four statutory categories," i.e., a
process, machine, manufacture, or composition of matter. Id. If the claims
constitute patentable subject matter, we then proceed to the second step, in
which we determine whether the claims fall into one of the judge-made
exceptions to the four categories. Id.
In the instant appeal, we disagree with the Examiner that the claim
language does not claim a process. The claims recite a method of ( 1)
determining a person's APO E genotype; (2) prescribing a diet based upon
that APO E genotype; (3) prescribing an exercise regime based upon the
APO E genotype to establish a targeted ratio of body fat mass to lean body
mass. Consequently, the claims recite a method for establishing a dietary
and exercise regime based upon the individual's APO E genotype to achieve
a targeted result. We consequently find the claims recite a method, one of
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the four categories of patentable subject matter, and we then move on to the
second-step of the analysis.
The second step requires us to inquire as to whether the claim is
directed to a judicial exception. Interim Guidance, 79 FR at 7 4621. A claim
is directed to a judicial exception when a law of nature, a natural
phenomenon, or an abstract idea is recited (i.e., set forth or described) in the
claim. Id. at 74622. Such a claim requires closer scrutiny for eligibility
because of the risk that it will "tie up" the excepted subject matter and pre-
empt others from using the law of nature, natural phenomenon, or abstract
idea. Id.
In the instant appeal, the claim is directed to a natural phenomenon;
viz., the relationship between APO E genotype and fat metabolism.
Appellant's Specification discloses that it is well-known in the art that
"[a]polipoprotein Eis a protein connected to fat and fat metabolism" and
that "[t]here are three variations of the APO E gene. Spec. p. 2, 11. 1, 15.
The fact that some variants are not as efficient as others at removing
unwanted cholesterol, fat, proteins and other substances from the
bloodstream carries huge health implications." Id. at 2, 11. 1-17.
Appellant's claims are directed to prescribing specific dietary and exercise
regimens that are tailored to accommodate this natural phenomenon in such
a manner as to achieve desired body fat/lean mass ratios.
Having determined that a natural phenomenon is at the heart of the
claim, we next determine whether any element, or combination of elements,
in the claim is sufficient to ensure that the claim amounts to significantly
more than the judicial exception. Interim Guidance, 79 FR at 74624. To be
patent-eligible, a claim that is directed to a judicial exception must include
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additional features to ensure that the claim describes a process or product
that applies the exception in a meaningful way, such that it is more than a
drafting effort designed to monopolize the exception. Id. In performing this
analysis, it is important to consider the claim as whole. Id.
The Supreme Court has identified a number of considerations for
determining whether a claim with additional elements amounts to
significantly more than the judicial exception itself. Id. Limitations that
may be enough to qualify as ''significantly more'' when recited in a claim
with a judicial exception include: (1) improvements to another technology
or technical field; (2) applying the judicial exception with, or by use of, a
particular machine; (3) effecting a transformation or reduction of a particular
article to a different state or thing; ( 4) adding a specific limitation other than
what is well-understood, routine and conventional in the field, or adding
unconventional steps that confine the claim to a particular useful application;
or ( 5) other meaningful limitations beyond generally linking the use of the
judicial exception to a particular technological environment. Id. (citing
Alice Corp., 134 S.Ct. at 2359; Bilski v. Kappas, 130 S.Ct. 3218, 1327
(2010); Diamond v. Diehr, 450 U.S. 175, 184 (1981); Mayo, 132 S.Ct. at
1299, 1302; Alice Corp., 134 S.Ct. at 2360).
Limitations that have been found to be insufficient to qualify as
"significantly more" when recited in a claim with a judicial exception
include: (1) simply appending well-understood, routine and conventional
activities previously known to the industry, specified at a high level of
generality, to the judicial exception; adding insignificant extrasolution
activity to the judicial exception, e.g., mere data gathering in conjunction
with a law of nature or abstract idea; or (3) generally linking the use of the
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judicial exception to a particular technological environment or field of use.
Id. (citing Alice Corp., 134 S.Ct. at 2359; Mayo, 132 S.Ct. at 1297-98;
Parker v. Flook, 437 U.S. 584, 589-90 (1978)).
We are not persuaded by Appellant's arguments that the claims are
sufficient to ensure that the claim amounts to significantly more than the
judicial exception. In performing our analysis, we find the Supreme Court's
analysis in Mayo instructive. In Mayo, the patents-in-issue claimed
administration of a thiopurine drug to a patient suffering from a
gastrointestinal disease, determining the level of the drug in the patient's
blood, and, depending of the level of the measured thiopurine, administering
more or less of the drug subsequently administered to the subject. Mayo,
132 S.Ct. at 1295.
The Court reasoned that, if a law of nature is not patentable, then
neither is a process reciting a law of nature, unless that process has
additional features that provide practical assurance that the process is more
than a drafting effort designed to monopolize the law of nature itself. Id. at
1297. The Court found the process that the claims at issue recited told
doctors interested in the subject about the correlations that researchers
discovered. Id. The Court found 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. at 1298.
Consequently, the Court held, the claims were unpatentable. Id.
In the instant appeal, Appellant has claimed a natural phenomenon:
the relationship between APO E genotype and fat metabolism. Specifically,
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the claims recite determination of an individual's genotype to prescribe
dietary and exercise regimes that are designed to help the patient meet
targeted fat/lean body mass. However, we find that prescribing dietary and
exercise regimes to achieve fat/lean body mass targets are well-known and
conventional means of achieving this end. See Spec. p. 5, 11. 22-30. We are
not persuaded by Appellant that using determination of a patient's APO E
genotype to inform the patient's dietary and exercise regimes to achieve a
desired phenotypic end adds significantly more than the judicial exception
itself in this case, any more than determining the amount of a thiopurine in a
patient's blood and using that determination to further determine the amount
of a drug to administer added in Mayo. We consequently affirm the
Examiner's rejection of the claims as being directed to non-statutory subject
matter.
DECISION
The Examiner's rejection of claims 1, 11, and 21-24 as unpatentable
under 35 U.S.C. § 101 is affirmed.
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).
AFFIRMED
kis
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