McDonald Cassidy, Pamela

Patent Trials and Appeals Board

Feb 12, 2020

15052825 - (D) (P.T.A.B. Feb. 12, 2020)

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.
15/052,825 02/24/2016 Pamela McDonald Cassidy 110573-8002.US02 1048
22918 7590 02/12/2020
PERKINS COIE LLP - PAO General
P.O. BOX 1247
SEATTLE, WA 98111-1247
EXAMINER
POHNERT, STEVEN C
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
02/12/2020 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 CASSIDY1
Appeal 2019-000514
Application 15/052,825
Technology Center 1600
Before ERIC B. GRIMES, DEBORAH KATZ, and MICHAEL A. VALEK,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving a method of
creating a nutrition and fitness plan, which have been rejected as indefinite,
lacking adequate written description, patent-ineligible, and obvious. We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM the rejections for obviousness and patent-ineligibility.

1 Appellant identifies the real party in interest as “Pamela McDonald
CASSIDY.” Appeal Br. 3. We use the word Appellant to refer to “applicant”
as defined in 37 C.F.R. § 1.42(a).
Appeal 2019-000514
Application 15/052,825

2
STATEMENT OF THE CASE
“The APO E gene variations occur naturally, and come in three major
types— APO E2, E3, and E4. . . . Because you inherit two copies of the
APO E gene, one from each parent, there are six possible combinations:
E2/2, E2/3, E2/4, E3/3, E3/4, and E4/4.” Spec. 2:17–22.
“If you take an APO E gene blood test and are identified as APO E
3/3, the APO E genetic instructions in your body are considered neutral.
However, if you are an APO E2 or APO E4 combination, you inherited an
APO E gene with an alternative expression, which means your body handles
foods and chemistry differently than an APO 3 individual does.” Id. at 2:24–
28. “The invention is based upon the insight that knowing your APO E
genotype can help you eat the right diet to maintain a safe optimal level of
cholesterol in your system. The preferred embodiment of the invention
provides a nutritional plan based on a person’s individual genetic APO E
genotype.” Id. at 4:18–21.
Claim 24 is the only pending claim and reads:
24. A method for creating and optimizing a nutritional
and fitness plan, comprising
performing a body composition bio-impedance test on a
human individual to determine the individual’s caloric needs
for activities of daily living for two basic activity levels, said
activity levels comprising both a normal activities of daily
living caloric requirement as is necessary to sustain said
individual’s typical daily activity, and additional calories for
daily activity of said individual that requires additional caloric
use;
collecting a blood sample from said individual and
submitting said blood sample for testing to determine said
individual’s apolipoprotein E (APO E) genotype;
Appeal 2019-000514
Application 15/052,825

3
analyzing said blood sample to determine said
individual’s apolipoprotein E (APO E) genotype;
based upon both of said individual’s APO E genotype
and the results of said bioimpedance test:
applying a genotype specific nutritional plan and
establishing optimal dietary levels of caloric content, fat content
and type of fats, carbohydrate content and type of
carbohydrates, and protein content and type of proteins, said
nutritional plan establishing dietary levels of:
fat content and 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; and
carbohydrate content and type of carbohydrates for
said genotype selected from among carbohydrates having
various glycemic loads, and protein content and type of proteins
for said genotype selected from among proteins coming from
plant sources and proteins coming from fish and other animal
sources;
said nutritional plan establishing a ratio of fat content to
carbohydrate content based upon said individual’s APO E
genotype, said ratio comprising:
for APO E 2/2, 35% fat content, 15% protein
content, and 50% carbohydrate content;
for APO E 2/3, 30% fat content, 15% protein
content, and 55% carbohydrate content;
for APO E 3/3 and APO E 2/4, 25% fat content,
20% protein content, and 55% carbohydrate content; and
for APO E 3/4 and APO E 4/4, 20% fat content,
25% protein content, and 55% carbohydrate content; and
applying an exercise plan to maintain genotype specific
body fat mass and lean mass, said exercise plan comprising:
Appeal 2019-000514
Application 15/052,825

4
for APO E 2/2 and APO E 2/3, 45% aerobic
exercise and 55% anaerobic exercise;
for APO E 3/3 and APO E 2/4, 50% aerobic
exercise and 50% anaerobic exercise; and
for APO E 3/4 and APO E 4/4, 75% aerobic
exercise and 25% anaerobic exercise.
OPINION
Definiteness
Claim 24 stands rejected under 35 U.S.C. § 112, second paragraph, as
indefinite, for the reasons discussed below. Ans. 6–8.
Appellant argues: “As noted by [MPEP § 2173.01], “a claim may not
be rejected solely because of the type of language used to define the subject
matter for which patent protection is sought.” Here, the M.P.E.P. does not
allow the Examiner to reject the claims simply because of the language
used.” Appeal Br. 9.
We agree with Appellant that the rejection should be reversed because
the Examiner has not established that claim 24, contains words or phrases
whose meaning is unclear. See Ex parte McAward, No. 2015-006416, 2017
WL 3669566, at *5 (PTAB Aug. 25, 2017) (precedential) (“[W]e apply the
approach for assessing indefiniteness approved by the Federal Circuit in [In
re Packard, 751 F.3d 1307 (Fed. Cir. 2014)], i.e., ‘[a] claim is indefinite
when it contains words or phrases whose meaning is unclear.’ 751 F.3d at
1310, 1314.”).
The Examiner first finds claim 24 to be indefinite “because it lacks a
positive active step relating back to the preamble.” Ans. 6. The Examiner
reasons that the preamble of claim 24 “recites a method for creating and
Appeal 2019-000514
Application 15/052,825

5
optimizing a nutritional and fitness plan, however the last positive active
step is drawn to applying a genotype specific nutritional plan.” Id. The
Examiner states that it is therefore unclear “whether the method is drawn to
creating and optimizing a nutritional and fitness regime or applying a
genotype specific nutritional plan.” The Examiner also finds that “it is
unclear how the nutritional and fitness regime is optimized.” Id.
We do not agree that claim 24 is indefinite on this basis. The
Specification makes clear that “[t]he invention is based upon the insight that
knowing your APO E genotype can help you eat the right diet to maintain a
safe optimal level of cholesterol in your system.” Spec. 4:18–20. The
Specification describes “a nutritional plan based on a person’s individual
genetic APO E genotype,” and varies the content and type of fat,
carbohydrate, and protein, as well as caloric content of the plan. Id. at 4:20–
29. The Specification also describes “exercise recommendations related to
the APO E genotypes.” Id. at 25:23, Table 2. Thus, the claim language, read
in light of the Specification, would be understood to mean a nutrition and
fitness plan that is optimized for an individual’s APO E genotype.
The Examiner also finds that “[i]t is unclear what is required of
‘additional calories for daily activity of said individual that requires
additional caloric use.’” Ans. 6. The Specification, however, states that
calculating individual daily caloric needs requires
add[ing] additional calories to your daily exercise session, such
as an exercise program or energetic activity that requires
additional caloric use. Examples of added exercise sessions: 30
minutes of running, 40 minutes of walking, or 60 minutes of
biking. These are calories needed in addition to the calories of
your normal activities of daily living.
Appeal 2019-000514
Application 15/052,825

6
Spec. 8:26–30. Thus, read in light of the Specification, the disputed
limitation would be understood to mean the calories that are burned by an
individual in exercise or energetic activity, in addition to activities of normal
or typical daily living. See id. at 8:23–24.
The Examiner also finds that claim 24 is indefinite in its recitation of
“applying a genotype specific nutritional plan and establishing optimal
dietary levels of caloric content,” etc. Ans. 7. The Examiner states that “[i]t
is unclear if optimal is with respect to fat loss, muscle gain, fat gain, etc.”;
“it is unclear what is what is [sic] considered of a plan”; “it is unclear if
regime is a dietary level of a single meal”; and “it is unclear if a plan is a
menu, recipe, or merely number of calories.” Id.
We disagree that any of these issues renders claim 24 indefinite. As
discussed above, the Specification makes clear that the nutritional
optimization involved in the claimed method refers to varying the contents
of an individual’s diet, based on their APO E genotype, in order to increase
health benefits. In addition, claim 24 itself makes clear that the “nutritional
plan establish[es] a ratio of fat content to carbohydrate content based upon
said individual’s APO E genotype.” Whether that plan is followed based on
each recipe, each meal, or each day does not affect the scope of claim 24 in
creating the nutritional plan tailored to the individual’s APO E genotype.
Finally, the Examiner notes that claim 24 recites “inflammatory fats
and anti-inflammatory fats” but concludes that the metes and bounds of
these terms is unclear from the Specification. Ans. 7–8. Claim 24, however,
expressly states that “inflammatory fats, compris[e] fats that come mainly
Appeal 2019-000514
Application 15/052,825

7
from saturated and trans fat sources, and anti-inflammatory fats, compris[e]
fats that come mainly from monounsaturated and polyunsaturated sources.”
In summary, we reverse all of the bases of the rejection under 35
U.S.C. § 112, second paragraph.
Written Description
Claim 24 stands rejected under 35 U.S.C. § 112, first paragraph, for
lack of adequate written description. Ans. 3. The Examiner finds that the
Specification does not adequately describe the claim limitations reciting
“additional calories for daily activity of said individual that
requires additional caloric use” or “based upon both of said
individual’s APO E genotype and the results of said bio-
impedance test: applying a genotype specific nutritional plan
and establishing optimal dietary levels of caloric content, fat
content and type of fats, carbohydrate content and type of
carbohydrates, and protein content and type of proteins; and
creating an exercise regime [sic, plan] to maintain a genotype
specific percentage of body fat mass and lean mass.”
Id. at 4.
Appellant points to the description in the Specification of additional
calories required for low, medium, and high levels of activity. Appeal Br. 6,
citing paragraphs 38–43 of the published application. Regarding a nutritional
plan and exercise plan based on both APO E genotype and the results of a
bio-impedance test, Appellant points to the published application’s
paragraphs 38, 46–51, 59, and 105–107 for support. Id. at 7.
We conclude that a skilled artisan would have recognized that
Appellant was in possession of a method meeting the disputed limitations
based on the written description in the Specification. The Specification
provides estimates of daily living calorie calculations for low level activity
Appeal 2019-000514
Application 15/052,825

8
(exercise 1–2 days/week), medium level activity (exercise 3–4 days/week),
and high level activity (exercise 6–7 days/week). Spec. 10:11–26. We
therefore agree with Appellant that the Specification adequately describes
“additional calories for daily activity of said individual that requires
additional caloric use.”
The Specification also states that the amount of energy needed by the
body to maintain basic functions “is called a basal metabolic rate (BMr).”
Spec. 9:10–11. A “practical way to calculate your BMr is to consider a bio-
impedance test,” which evaluates body composition and “gives you your
daily caloric requirement.” Id. at 9:15–17. “A bio-impedance test gives you
your daily caloric requirements immediately.” Id. at 9:28–29. The
Specification therefore describes using a bio-impedance test as part of the
basis for establishing at least an optimal level of caloric content.
And the Specification describes optimizing the type and content of
dietary fat, carbohydrate, and protein, as well as the type of exercise,
depending on an individual’s APO E genotype. See Spec. 11:4 to 15:17,
25:21 to 27:27. Thus, when viewed as a whole, the Specification
demonstrates possession of the disputed limitations.
We therefore reverse the rejection under 35 U.S.C. § 112, first
paragraph.
Patent Eligibility
Claim 24 stands rejected under 35 U.S.C. § 101 on the basis that it is
“directed to a judicial exception (i.e., a law of nature, a natural phenomenon,
or an abstract idea) without significantly more”; specifically, the “judicial
exception of correlating genotype and basal metabolic rate determined by
Appeal 2019-000514
Application 15/052,825

9
bio impedance with prescribing exercise and nutritional regime. Further the
analyzing and creating are abstract ideas.” Ans. 8–9. The Examiner also
states that “the claims are based on the judicial exception of naturally
occurring correlating [sic, correlating naturally occurring] APOE genotype
and basal metabolic rate with prescribing exercise and nutritional regime.
Further the analyzing and applying are abstract ideas.” Id. at 9.
The Examiner finds that the recited steps of performing a bio-
impedance test and collecting a blood sample are “routine and conventional
data gathering steps.” Id. at 11–12. The Examiner also finds that “[t]he
recited steps only instruct the user to engage in well-understood, routine and
conventional activity . . . since methods of analyzing nucleic acids . . . were
conventional in the art at the time the invention was made.” Id. at 12. The
Examiner therefore concludes that the claims do not “recite something
significantly different than a judicial exception,” and are ineligible for
patenting. Id. at 14.
Appellant argues that claim 24 is “a unique approach to creating and
optimizing a nutritional and fitness plan and not ‘on the judicial exception of
naturally occurring correlat[ion].’” Appeal Br. 10 (alteration in original).
Appellant argues that the use of a bio-impedance test and APO E genotype
“together to create and optimize a nutritional and fitness plan are not ‘a
naturally occurring correlation between the APO E genotype and exercise
and nutrition’ as asserted by the Examiner.” Id. Appellant also argues that
“the determination of nutritional and fitness plan based on the APO E
genotype and the result of the bio-impedance test is not well understood,
routine or conventional.” Id.
Appeal 2019-000514
Application 15/052,825

10
An invention is patent-eligible if it claims a “new and useful process,
machine, manufacture, or composition of matter.” 35 U.S.C. § 101.
However, the Supreme Court has concluded that “[l]aws of nature, natural
phenomena, and abstract ideas” are not patentable under 35 U.S.C. § 101.
See, e.g., Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 216 (2014).
To determine if a claim falls into an excluded category, we apply a
two-step framework, described in Mayo and Alice. Alice, 573 U.S. at 217–18
(citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66,
75–77 (2012)). We first determine what the claim is “directed to.” See Alice,
573 U.S. at 219 (“On their face, the claims before us are drawn to the
concept of intermediated settlement, i.e., the use of a third party to mitigate
settlement risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010)
(“Claims 1 and 4 in petitioners’ application explain the basic concept of
hedging.”).
Patent-ineligible abstract ideas include certain methods of organizing
human activity, such as fundamental economic practices (Alice, 573 U.S. at
219–20; Bilski, 561 U.S. at 611), mathematical formulas (Parker v. Flook,
437 U.S. 584, 594–95 (1978)), and mental processes (Gottschalk v. Benson,
409 U.S. 63, 67 (1972)). In contrast, patent-eligible inventions include
physical and chemical processes, such as “molding rubber products”
(Diamond v. Diehr, 450 U.S. 175, 191 (1981)); “tanning, dyeing, making
water-proof cloth, vulcanizing India rubber, smelting ores” (id. at 182 n.7
(quoting Corning v. Burden, 56 U.S. 252, 267–68 (1853))); and
manufacturing flour (Benson, 409 U.S. at 69 (citing Cochrane v. Deener, 94
U.S. 780, 785 (1876))).
Appeal 2019-000514
Application 15/052,825

11
In Diehr, the claimed method employed a mathematical formula, but
the Supreme Court held that “a claim drawn to subject matter otherwise
statutory does not become nonstatutory simply because it uses a
mathematical formula.” Diehr, 450 U.S. at 187; see also id. at 191 (“We
view respondents’ claims as nothing more than a process for molding rubber
products and not as an attempt to patent a mathematical formula.”). The
Supreme Court noted, however, that a claim “seeking patent protection for
that formula in the abstract . . . is not accorded the protection of our patent
laws, and this principle cannot be circumvented by attempting to limit the
use of the formula to a particular technological environment.” Id. (citing
Benson and Flook); see, e.g., id. at 187 (“It is now commonplace that an
application of a law of nature or mathematical formula to a known structure
or process may well be deserving of patent protection.”).
If the claim is “directed to” an abstract idea, we turn to the second
step of the Alice and Mayo framework, and “examine the elements of the
claim to determine whether it contains an ‘inventive concept’ sufficient to
‘transform’ the claimed abstract idea into a patent-eligible application.”
Alice, 573 U.S. at 221 (internal quotation marks omitted). “A claim that
recites an abstract idea must include ‘additional features’ to ensure ‘that the
[claim] is more than a drafting effort designed to monopolize the [abstract
idea].’” Id. (quoting Mayo, 566 U.S. at 77 (alterations in original)).
“[M]erely requir[ing] generic computer implementation[] fail[s] to transform
that abstract idea into a patent-eligible invention.” Id.
The PTO has published revised guidance on the application of § 101.
2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50
Appeal 2019-000514
Application 15/052,825

12
(January 7, 2019) (“Revised Guidance”). Under that guidance, we first
determine whether the claim recites:
(1) any judicial exceptions, including certain groupings of
abstract ideas (i.e., mathematical concepts; certain methods of
organizing human activity such as a fundamental economic
practice; or mental processes); and
(2) additional elements that integrate the judicial exception into
a practical application (see MPEP §§ 2106.05(a)–(c), (e)–(h)).
See 84 Fed. Reg. at 54–55. Only if a claim (1) recites a judicial exception and
(2) does not integrate that exception into a practical application, do we then
determine whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not
a “well-understood, routine, conventional activity” in the field (see
MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities
previously known to the industry, specified at a high level of
generality, to the judicial exception.
See 84 Fed. Reg. at 56.
Revised Guidance Step 2(A), Prong 1
Following the Revised Guidance, we first consider whether claim 24
recites a judicial exception, such as mental processes. We agree with the
Examiner that the “applying” steps of claim 24 are abstract ideas, because
they are mental processes. See Ans. 9 (“Further, the analyzing and applying
are abstract ideas.”); id. at 31 (“[T]he step of applying is consistent with the
prescribing step of claims of the parent” application.).
Appeal 2019-000514
Application 15/052,825

13
Claim 24 recites “applying a genotype specific nutritional plan.” The
plan recites types of fats, carbohydrates, and proteins, and provides for a
distribution of a person’s diet among those categories; e.g., for a person with
an APO E 2/2 genotype, 35% fat content, 15% protein content, and 50%
carbohydrate content. Claim 24 also recites “applying an exercise plan,”
which provides for a distribution of exercise between aerobic and anaerobic
exercise; e.g., for a person with an APO E 2/2 genotype, 45% aerobic
exercise and 55% anaerobic exercise.
Both of these steps can be carried out mentally, because they only
require associating a person’s genotype with a diet and exercise regimen that
is suited to the type(s) of APO E that their cells express. The Specification
makes clear that the claimed method simply recommends or prescribes a diet
and exercise regimen; the method does not require actually eating or
exercising in specific ways. The Specification states, for example, that “[t]he
preferred embodiment of the invention provides an APO E gene micro and
macronutrient nutritional recommendation, i.e. the APO E gene diet.” Spec.
5:8–9.
The Specification also states that “Fig. 1 is a chart showing a
nutritional plan based on a person’s individual genetic APO E genotype
according to the invention.” Id. at 6:1–2. Figure 1 shows a “SPECIFIC
GENOTYPE DIETARY RECOMMENDATION” and an “EXERCISE
PRESCRIPTION” for each of the six possible APO E genotypes. Thus,
when the “applying” steps of claim 24 are read in light of the Specification,
they require no more than looking at Figure 1 to see what dietary
Appeal 2019-000514
Application 15/052,825

14
recommendation and exercise prescription is appropriate for a particular
individual, based on that individual’s APO E genotype.
Revised Guidance Step 2(A), Prong 2
Following the Revised Guidance, we next consider whether “the claim
as a whole integrates the recited judicial exception into a practical
application of the exception”; i.e., whether the claim “appl[ies], rel[ies] on,
or use[s] the judicial exception in a manner that imposes a meaningful limit
on the judicial exception.” 84 Fed. Reg. at 54. This analysis includes
“[i]dentifying whether there are any additional elements recited in the claim
beyond the judicial exception(s)” and “evaluating those additional elements
individually and in combination to determine whether they integrate the
exception into a practical application.” Id. at 54–55.
Here, claim 24 requires the initial steps of
performing a body composition bio-impedance test on a
human individual to determine the individual’s caloric needs
for activities of daily living . . . ;
collecting a blood sample from said individual and
submitting said blood sample for testing to determine said
individual’s apolipoprotein E (APO E) genotype; [and]
analyzing said blood sample to determine said
individual’s apolipoprotein E (APO E) genotype.
Claim 24.
These steps determine (a) the number of calories an individual needs
on a daily basis and (b) the individual’s APO E genotype. See Spec. 9:15–17
(“[A] practical way to calculate your BMr [basal metabolic rate] is to
consider a bioimpedance test. This is an accurate method and most
convenient method of evaluating body composition, which gives you your
Appeal 2019-000514
Application 15/052,825

15
daily caloric requirement.”); id. at 11:6–8 (“To help you identify the correct
diet type based on your APO E genotype: Find the recommendation for your
specific APO E. If you have not yet been tested, consider getting a APO E
genotype test.”).
The active steps recited in claim 24 thus provide the data for the
recited mental process of “applying” a nutritional plan and an exercise plan.
In other words, the “performing,” “collecting,” and “analyzing” steps of
claim 24 are merely data-gathering steps, not a practical application of the
mental process of “applying” a nutritional plan and an exercise plan. They
therefore do not integrate the recited abstract idea into a practical
application. See 84 Fed. Reg. at 55, n. 31 (“insignificant extra-solution
activity” includes “mere data gathering such as a step of obtaining
information about credit card transactions”); see also Ultramercial, Inc. v.
Hulu, LLC, 772 F.3d 709, 716 (Fed. Cir. 2014) (“‘[D]ata-gathering steps,’
CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1370 (Fed. Cir.
2011), . . . add nothing of practical significance to the underlying abstract
idea.”).
Claim 24 does not include “an additional element that applies or uses
a judicial exception to effect a particular treatment or prophylaxis for a
disease or medical condition.” 84 Fed. Reg. at 55. As discussed above, the
claimed method ends with “applying”—that is, recommending or
prescribing—a diet and exercise regimen for an individual, but it includes no
active step(s) in which the diet and exercise regimen are put into practice.
The claimed method does not actually treat any individual, because it does
not include any active steps of eating or exercising.
Appeal 2019-000514
Application 15/052,825

16
The claimed method is distinguished in this way from Vanda Pharms.
Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018). In
Vanda, the “claims [were] directed to a method of using iloperidone to treat
schizophrenia.” Id. at 1135. Critically, the claims “require[d] a treating
doctor to administer iloperidone in the amount of either (1) 12 mg/day or
less or (2) between 12 mg/day to 24 mg/day, depending on the result of a
genotyping assay” in order to reduce the risk of a side effect called QTc
prolongation. Id. Thus, the court held that the “claims [were] ‘a new way of
using an existing drug’ that is safer for patients because it reduces the risk of
QTc prolongation.” Id.
The claim here, by contrast, conveys information, in the form of
dietary and exercise recommendations, to an individual but does not include
any step comparable to Vanda’s step of administering an adjusted dose of
iloperidone to a patient in order to treat schizophrenia more safely.
Because claim 24 recites an abstract idea and does not integrate the
abstract idea into a practical application, it is directed to an abstract idea.
Revised Guidance Step 2(B)
Finally, the Revised Guidance directs us to consider whether claim 24
includes “additional elements . . . [that] provide[] ‘significantly more’ than
the recited judicial exception.” 84 Fed. Reg. at 56. The Revised Guidance
states that an additional element that “simply appends well-understood,
routine, conventional activities previously known to the industry, specified
at a high level of generality, to the judicial exception, . . . is indicative that
an inventive concept may not be present.” Id.
Appeal 2019-000514
Application 15/052,825

17
Here, as discussed above, the additional elements recited in claim 24,
beyond the abstract idea to which it is directed, are the data-gathering steps
of “performing a body composition bio-impedance test,” “collecting a blood
sample,” and “a blood sample.” The Revised Guidance instructs us to
reevaluate additional elements that were found to be insignificant extra-
solution activity under Step 2(A) of the analysis to determine whether those
elements are “unconventional or otherwise more than what is well-
understood, routine, conventional activity in the field.” 84 Fed. Reg. at 56.
The Revised Guidance states, for example, that
when evaluating a claim reciting an abstract idea . . . and a
series of data gathering steps that collect a necessary input . . . ,
an examiner might consider the data gathering steps to be
insignificant extra-solution activity in revised Step 2A, and
therefore find that the judicial exception is not integrated into a
practical application. However, when the examiner reconsiders
the data gathering steps in Step 2B, the examiner could
determine that the combination of steps gather data in an
unconventional way and therefore include an “inventive
concept,” rendering the claim eligible at Step 2B.
Id. (footnote omitted).
Here, the Examiner points to Bernstein2 and Kopelman,3 among other
references, as evidence that the bio-impedance test and APO E genotyping
step “are merely routine and conventional.” Ans. 30. Bernstein states that
“[t]he sequence of the apoE gene and of its protein are well known, and the

2 Martine S. Bernstein, Physical Activity May Modulate Effects of ApoE
Genotype on Lipid Profile, Arterioscler. Thromb. Vasc. Biol. 22:133–140
(2002).
3 Peter G. Kopelman, Obesity as a medical problem, Nature 404:635–643
(2000).
Appeal 2019-000514
Application 15/052,825

18
complete DNA and mRNA nucleotide sequences are available on public
databases.” Bernstein 134, right col. Bernstein also discloses using blood
samples for APO E genotyping. Id. Thus, the steps of collecting a blood
sample and analyzing it to determine an individual’s APO E genotype are
routine and conventional activities.
Kopelman “review[s] the epidemiology and factors influencing
obesity and the health consequences of excessive body fat.” Kopelman 635,
left col. “Box 1 details the practical methods used in clinical practice to
assess body fatness.” Id. at 635, right col. Kopelman’s Box 1 includes
“Bioimpedance.” Id. at 635.
The evidence of record therefore supports the Examiner’s conclusion
that claim 24 does not recite additional elements other than well-known,
routine, and conventional activities. Ans. 11–12. We agree with the
Examiner that the combination of elements recited in the method of claim 24
does not amount to significantly more than the judicial exception itself, and
under 35 U.S.C. § 101 the claimed method is ineligible for patenting.
Appellant’s Arguments
Appellant argues that the claim is
a unique approach to creating and optimizing a nutritional and
fitness plan and not “on the judicial exception of naturally
occurring correlat[ion]” as indicated by the Examiner. The use
of a bio-impedance test is not the preemption of the law of
nature concerning basal metabolic rate, and the determining of
APO E genotype is not the preemption of the law of nature
concerning the APO E genotype itself. The use of both together
to create and optimize a nutritional and fitness plan are not “a
naturally occurring correlation between the APO E genotype
and exercise and nutrition” as asserted by the Examiner.
Appeal 2019-000514
Application 15/052,825

19
Appeal Br. 10 (alteration in original).
This argument is unpersuasive. Even assuming that the claims do not
recite a naturally occurring correlation, they nonetheless recite the mental
processes of “applying” nutritional and exercise plans, as discussed above.
The argument that the claimed method does not preempt either bio-
impedance tests or APO E genotyping is unpersuasive because,
[w]hile preemption may signal patent ineligible subject matter,
the absence of complete preemption does not demonstrate
patent eligibility. . . . Where a patent’s claims are deemed only
to disclose patent ineligible subject matter under the Mayo
framework, as they are in this case, preemption concerns are
fully addressed and made moot.
Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir.
2015).
Appellant also argues that “the determination of nutritional and fitness
plan based on the APO E genotype and the result of the bio-impedance test
is not well understood, routine or conventional.” Appeal Br. 10. Appellant
argues that “the inventor discovered an optimized nutritional and fitness plan
customized to patients based on results of bio-impedance testing. The
claimed subject matter significantly adds details that are not known or
suggested by the alleged laws of nature as they are understood.” Id. at 10–
11.
This argument is unpersuasive because the issue is not whether the
claimed process as a whole was known, but whether, in addition to the
judicial exception, the claimed process includes elements that go beyond
well-understood, routine, and conventional activity known to those in the
field. See Alice, 573 U.S. at 217 (If “the claims at issue are directed to one of
Appeal 2019-000514
Application 15/052,825

20
th[e] patent-ineligible concepts . . . 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 claim’ into a patent-eligible
application.”) (internal citation omitted).
Here, as discussed above, the evidence shows that bio-impedance
testing and APO E genotype analysis were routine and conventional
activities. To the extent that considering both bio-impedance test results and
APO E genotype when recommending a diet and exercise regimen is an
improvement over conventional approaches to diet and exercise, the
improvement is in the mental process of deciding on the foods and exercises
that would benefit an individual. Cf. SAP Am., Inc. v. InvestPic, LLC, 898
F.3d 1161, 1163 (Fed. Cir. 2018) (An “advance [that] lies entirely in the
realm of abstract ideas, with no plausibly alleged innovation in the non-
abstract application realm . . . is ineligible for patenting.”).
Obviousness
Claim 24 stands rejected under 35 U.S.C. § 103(a) as obvious based
on Roberts,4 Bernstein, Kopelman, Singhal,5 Brooks,6 and Sakata.7 Ans. 14.
The Examiner finds that Roberts teaches “a method for selecting an optimal
diet and exercise regimen for a patient, comprising considering,” among

4 Roberts et al., US 2005/0009193 A1, pub. Jan. 13, 2005.
5 Atul Singhal et al., Programming of lean body mass: a link between birth
weight, obesity, and cardiovascular disease?, Am. J. Clin. Nutr. 77:726–730
(2003).
6 George A. Brooks et al., Exercise Physiology: Human Bioenergetics and
Its Applications, 2nd ed., Mayfield Publishing Company, p. 525(1996).
7 Sakata et al., US 6,477,409 B2, iss. Nov. 5, 2002.
Appeal 2019-000514
Application 15/052,825

21
other factors, “APO E genotype; and selecting a diet and exercise regimen”
based on these factors. Id. The Examiner finds that Roberts recommends “a
diet moderate in fat content, consisting of 30–35% of total calories,” for
individuals with APO E 2/2 and 2/3 genotypes. Id. at 14–15. “Roberts
teaches a diet for subjects with APO E3 and APO E2/4 should have fat
providing 25–30%[] of total calories.” Id. at 16.
The Examiner finds that Roberts does not teach testing an individual
to determine APO E genotype or “determining a specific exercise regime
based on the individual[’]s APO E genotype.” Id. at 17–18. The Examiner
finds, however, that “Bernstein teaches DNA was extracted from individuals
and Apo E genotypes were determined.” Id. at 18. The Examiner finds that
Bernstein also teaches that different intensities of exercise had different
effects on individuals’ HDL and triglyceride levels, depending on APO E
genotypes. Id.
The Examiner finds that “Kopelman teaches bio-impedance,”
“Singhal suggest that body composition is a more accurate determination of
obesity that surrogate markers such as BMI,” and Brooks “teaches ideal
body composition for men is 20% or less body fat . . . [and] for women is
between 16 and 25% body fat.” Id. at 19.
The Examiner finds that “[t]he prior art of record (Bernstein and
Kopelman) suggests determining a basal metabolic rate as part of exercise
plans, but does not provide specific guidance.” Id. at 20. The Examiner finds
that Sakata teaches “an apparatus for measuring basal metabolism” that
includes “a device to measure bioelectrical impedance” of a subject and
provides an improved method of determining basal metabolism. Id. at 21.
Appeal 2019-000514
Application 15/052,825

22
The Examiner concludes that it would have been obvious “to use the
genotyping methods taught by Bernstein in the method of Roberts . . .
because Roberts suggest[s] genotyping APO E and determination of diet
based on APO E genotype . . . [and] Bernstein teaches methods of
genotyping APO E were known.” Id. at 19. The Examiner concludes that it
would also have been obvious “to improve the method of Roberts to include
providing a genotype specific exercise regime as Bernstein teaches that
different exercise intensities have different effects on blood triglyceride and
HDL-cholesterol profiles based on APOE genotype.” Id.
The Examiner further concludes that it would have been obvious “to
use additional determination of body fat mass and lean fat mass in the
determinations of exercise and nutrition programs based on APO E
genotypes as taught by Roberts and Bernstein” with a “reasonable
expectation of success using known methods of determining percentage
body mass and lean body mass and Singhal teaches these methods were
known.” Id. at 20. Finally, the Examiner concludes that it would have been
obvious to use “the bioimpedance method of Sakat[a] to estimate caloric
intake required for additional activities. The artisan would be motivated to
determine basal metabolic rate and provide more concise exercise and
dietary regime.” Id. at 21.
Appellant argues:
The cited art does not mention an individual’s APO E
genotype and the result of a bio-impedance test, and therefore
cannot teach “applying a genotype specific nutritional regime
plan and establishing optimal dietary levels of caloric content,
fat content and type of fats, carbohydrate content and type of
carbohydrates, and protein content and type of proteins” based
Appeal 2019-000514
Application 15/052,825

23
on the “both of said individual’s APO E genotype and the result
of said bio-impedance test.”
Appeal Br. 13. Appellant also argues that “[t]he Examiner failed to indicate
a reason a person of ordinary skill in the art would be motivated to combine
the six references, none of which measure an individual’s APO E genotype
and bio-impedance to create a nutritional plan based on them.” Id. at 14.
We conclude that the cited references support a prima facie case of
obviousness. Roberts discloses “a method for selecting an optimal diet and
exercise regimen for a patient,” based on the patient’s APO E genotype,
among other factors. Roberts ¶ 10. For example, Roberts states that “APO E
2/2 and 2/3 individuals . . . ha[ve] a better outcome when diet is higher in fat
rather than sugar. . . . Therefore, a diet moderate in fat content, consisting of
30–35% of total calories, is recommended.” Id. ¶ 18.
Roberts also states that “[i]ndividuals who are homozygous for the
APO E3 allele (and APO E 2/4 . . . ) should follow a basic preventive diet.
Therefore, daily fat intake for prevention of cardiovascular disease should be
low, consisting of 25–30% of daily total calories.” Roberts ¶ 28. Roberts
also states that “[c]alorie content of preventive diet must be appropriate for
weight maintenance or weight loss depending on calculated goal weight or
% body fat.” Id.
Roberts states that “[i]ndividuals with at least one APO E4 allele (i.e.,
APO E 4/4 or 3/4, but excluding APO E 2/4) are most responsive to dietary
intervention and are particularly sensitive to fat intake. A diet very low in fat
(less than 20%) is recommended for this reason.” Id. ¶ 35.
Roberts does not disclose collecting a blood sample and analyzing it
to determine an individual’s APO E genotype, as recited in claim 24. And,
Appeal 2019-000514
Application 15/052,825

24
although Roberts states that “[p]hysical activity can positively influence
plasma lipid and lipoprotein concentration and reduce coronary artery
disease risk levels,” id. ¶ 97, it does not provide exercise recommendations
based on individuals’ APO E genotypes.
Bernstein, however, discloses both of these elements of the claim.
Bernstein assessed whether “lipid profile levels observed across apoE
genotype groups differed between more sedentary versus more active
subjects.” Bernstein 133, right col. Bernstein discloses that blood was
collected from participants, genomic DNA was extracted, and APO E
genotype was determined. Id. at 134, right col.; 135, Table 1. Thus, it would
have been obvious to a skilled artisan to include collecting a blood sample
and analyzing APO E genotype in Roberts’ method, because Roberts
discloses that an individual’s optimal diet depends on their APO E genotype.
Bernstein also discloses that “basal metabolic rate (BMR) . . . was
calculated for each participant. Each physical activity was previously
assigned a score indicating its intensity in terms of BMR multiples. For
example, when sleeping, an individual expends 1 time the energy required
by the BMR.” Bernstein 134, left col. “[M]oderate intensity activities
expend[ed] 3 to 3.9 times the BMR . . . . High-intensity and very high-
intensity activities expend[ed] ≥4 times the BMR.” Id. Bernstein reports that
“[a]mong men, the apoE4 group had significantly greater beneficial effects
of increased %high-intensity activity on HDL cholesterol . . . and
triglycerides . . . than either the apoE2 group . . . or the apoE3 group.” Id. at
135, right col. (Bernstein defines the apoE groups as follows: “ApoE[2]”
means APO E 2/2 and APO E 2/3; “ApoE3” means APO E 3/3; and
Appeal 2019-000514
Application 15/052,825

25
“ApoE4” means APO E 3/4 and APO E 4/4. Id. at 136, legend to Table 2.
Participants with APO E 2/4 genotypes were excluded. Id.)
Based on Bernstein, therefore, it would have been obvious to modify
Roberts’ method to include recommending higher intensity (i.e., more
aerobic) exercise to individuals having an APO E 3/4 or 4/4 genotype, as
compared to those having APO E 2/2, 2/3, or 3/3 genotypes.
Bernstein does not disclose performing a bio-impedance test to
calculate the basal metabolic rate (BMR) for an individual. However, Sakata
discloses “an apparatus for measuring basal metabolism.” Sakata 1:11–12.
Sakata’s apparatus includes “a device to measure bioelectrical impedance of
[a] subject” and “a device for calculation of basal metabolism of the
subject.” Id. at 2:10–14. Sakata states that its device “improves the accuracy
of an arithmetic method used to determine basal metabolism.” Id. at 2:17–
18.
Because Bernstein teaches that higher-intensity exercise, as
determined based on BMR multiples, is more beneficial to individuals with
APO E4 genotypes, it would have been obvious to modify the method made
obvious by Roberts and Bernstein to use Sakata’s device—which includes
measuring bioelectrical impedance, or bio-impedance—to determine an
individual’s BMR, because Sakata teaches that its device improves the
determination of basal metabolism.
The Examiner cites Kopelman, Singhal, and Brooks as evidence that
obesity is unhealthy and “body composition is a more accurate
determination of obesity tha[n] surrogate markers such as BMI.” Ans. 19.
These references thus show that a skilled artisan would have had a reason to
Appeal 2019-000514
Application 15/052,825

26
modify Roberts, Bernstein, and Sakata to optimize dietary and exercise
recommendations for an individual to promote a healthy weight.
Appellant argues that
[t]he cited art fails to teach “based upon both of said
individual’s APO E genotype and the result of said bio-
impedance test . . . applying a genotype specific nutritional
regime plan and establishing optimal dietary levels of caloric
content, fat content and type of fats, carbohydrate content and
type of carbohydrates, and protein content and type of
proteins.”
Appeal Br. 11–12. Appellant also argues that
[t]he cited art does not mention an individual’s APO E
genotype and the result of a bio-impedance test, and therefore
cannot teach “applying a genotype specific nutritional regime
plan and establishing optimal dietary levels of caloric content,
fat content and type of fats, carbohydrate content and type of
carbohydrates, and protein content and type of proteins” based
on the “both of said individual’s APO E genotype and the result
of said bio-impedance test.”
Id. at 13. Similarly, Appellant argues that “[t]he Examiner failed to indicate
a reason a person of ordinary skill in the art would be motivated to combine
the six references, none of which measure an individual’s APO E genotype
and bio-impedance to create a nutritional plan based on them.” Id. at 14.
These arguments are unpersuasive because the rejection is based on
what the cited references, when read together, would have suggested to those
skilled in the art. The Examiner provided reasons, based on the evidence,
that a skilled artisan would have combined their teachings. Ans. 19–21. For
the reasons discussed above, we agree with the Examiner that a person of
ordinary skill in the art would have had a reason to combine APO E
genotyping, as disclosed by Bernstein, and bio-impedance testing, as
Appeal 2019-000514
Application 15/052,825

27
disclosed by Sakata, with Roberts’ APO E genotype-based diet
recommendations and Bernstein’s recommendation for more high-intensity
exercise for individuals with APO E4 genotypes, resulting in the claimed
method.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
24 112, second
paragraph
Indefiniteness 24
24 112, first
paragraph
Written Description 24
24 101 Eligibility 24
24 103(a) Roberts, Bernstein,
Kopelman, Singhal,
Brooks, Sakata
24
Overall
Outcome
24

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED