Ex Parte Castellon et al

Patent Trial and Appeal Board

Dec 21, 2017

13448383 (P.T.A.B. Dec. 21, 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.
13/448,383 04/16/2012 Victor Castellon GENOVIVE-001002-US 6237
11132 7590 12/26/2017
Rmilware Rr Valnir
EXAMINER
Three Riverway, Suite 950
Houston, TX 77056
SALMON, KATHERINE D
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
12/26/2017 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):
patent @ boulwarevaloir.com
nseigel @ boulwarevaloir.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte VICTOR CASTELLON, PAUL CLINKSCALES,
JAMES DAVIS, RUTH DEBUSK, ROSALYNN GILL,
SAN SAN NG, and BEVERLY SWANGO1
Appeal 2017-001707
Application 13/448,383
Technology Center 1600
Before JOHN G. NEW, RICHARD J. SMITH, and DAVID COTTA,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
appellants state that the real party-in-interest is Genovive LLC. App. Br. 1.
Appeal 2017-001707
Application 13/448,383
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 1, 2, 9, 10, and 13 as unpatentable
under 35 U.S.C. § 101 as being directed to nonstatutory subject matter.
We have jurisdiction under 35 U.S.C. § 6(b).2
We AFFIRM.
NATURE OF THE CFAIMED INVENTION
Appellants’ invention is directed to a nutritional genomic weight
management algorithm running on a computer system and, more
specifically, a nutritional genomic weight management algorithm where an
analysis of a customer’s unique DNA results in individualized diet and
exercise plans. Abstract.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A method of weight management, comprising:
a. measuring at least three of a human client’s values
relating to weight, height, waist circumference, hip
circumference, body mass index, waist-to-hip ratio,
gender, and ethnicity,
b. isolating and processing DNA to determine the presence
or absence of exercise related variants or diet related
variants, said exercise related variants are rs9939609
(TT TA AA), rs4343 (GG GA AA), rsl042714 (CC CG
2 The Examiner’s rejections of the claims as unpatentable under 35 U.S.C.
§ 112, first paragraph, as lacking enablement and under 35 U.S.C. § 112,
second paragraph, as indefinite have been withdrawn. See Ans. 2.
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GG), rsl042713 (AA AG GG), and rs4994 (TT TC CC),
and said diet related variants are rs2943641 (CC CT
TT), rs9939609 (TT TA AA), rsl801282 (CC CG GG),
rsl800588 (CC CT TT), rsl799883 (GG GA AA),
rsl800629 (GG GA AA), rsl042714 (CC CG GG),
rs5082 (TT TC CC), rsl800795 (GG GC CC), and
rs2070895 (GG GA AA),
c. assigning a Carbohydrate Score, Fat Score and Exercise
Score, ranging from 0—5, for each determined genetic
variant in step b) based on the allele detected in said
human client’s DNA, and optionally also based on the
values obtained in step a),
d. summing said Carbohydrate Score, Fat Score and
Exercise Score,
e. selecting and implementing a diet plan and an exercise
plan based on the results of [steps] a—d, wherein said
summed Carbohydrate Scores exceeding a first
threshold results in a carbohydrate-controlled diet plan,
wherein said first threshold is 5, wherein said summed
Fat Scores exceeding a second threshold results in a fat
controlled diet plan, wherein said second threshold is
18,
wherein exceeding both first and second thresholds results
in a fat-and-carbohydrate-controlled diet plan, but
exceeding neither threshold results in a balanced diet plan,
and
said summed Exercise Scores exceeding a third threshold
results in a vigorous exercise plan, and not exceeding said
third threshold results in a moderate exercise plan, wherein
said third threshold is 10.
App. Br. 8-9.
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ISSUES AND ANALYSES
We adopt the Examiner’s findings of fact and conclusion that the
appealed claims are directed to nonstatutory subject matter. We address the
arguments raised by Appellants below.
Issue
Appellants argue that the Examiner erred because the claims are not
directed to nonstatutory subject matter. App. Br. 12.
Analysis
The Examiner finds the claims are directed to a method of weight
management comprising measuring a client’s physical values, isolating and
processing DNA to determine the presence or absence of ten variants,
assigning and summing a carbohydrate score, fat score, and exercise score.
Final Act. 25. The Examiner finds the claims do not include additional
elements that are sufficient to amount to significantly more than the judicial
exception, because the claims are based on the judicially-created exception
of detecting naturally occurring genetic variants, i.e., a phenomenon of
nature. Id.
Specifically, the Examiner finds the recited steps of measuring values,
isolating and processing DNA to determine presence or absence of genetic
variants, and assigning and summing, are recited with a high degree of
generality and encompass generally-known processing variants. Final Act.
27. The Examiner notes that these steps are not limited to a particular
methodology or to any specific reagent to detect the expression that
significantly narrow the scope of the claims. Id. The Examiner also finds
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that the steps reciting the assigning of scores and summing are mental steps.
Id. Therefore, the Examiner finds, the claims do not recite any elements or
steps that add anything significant to the judicial exception. Id.
Appellants argue that the Examiner’s rejection applies to all of the
claims, but that the Examiner only discusses a portion of the language in
claim 1, and omits consideration of unique language for the remaining
claims. App. Br. 12. By way of example, Appellants point to three of the
four independent claims, which require “providing meals” to the client,
which Appellants assert the Examiner ignores in the § 101 analysis. Id.
Appellants point to the Examiner’s conclusion that “the claims are
based on the judicial exception of naturally occurring genetic variants.”
App. Br. 12. Appellants assert that they do not claim DNA, and the
Examiner’s conclusion is therefore irrelevant. Id.
Appellants also argue that their claims do not preempt use of the
recited alleles. App. Br. 13. According to Appellants, the entire panel of
alleles could still otherwise be used in weight management, provided that the
user did not use the recited scoring and summing system or its equivalent,
provide diet and exercise plans (all claims), or use the same threshold values
for the specified plans (claims 1, 2, 8, and 10) or provide meals (claim 9, 10,
13) or exercise coaching (claim 13). Id.
Appellants next point to the Examiner’s finding that “the claims are
also considered to be based on the judicial exception of a law of
nature/natural principle” and that “[t]he claim does nothing more than spell
out what practitioners already knew—how to detect the variants and
assigning and summing scores, using ordinary techniques.” App. Br. 13
(quoting Final Act. 27). Appellants argue the Examiner considers only the
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allele-detecting, assigning, and summing steps in the claimed methods and
ignores all of the other steps. Id. Specifically, Appellants contend the
Examiner’s analysis ignores all of the weight management aspects of the
claim, and assert that the claimed invention is not a method of detecting
scoring and summing alleles, but is rather a method of weight management.
Id.
Appellants also argue that the additional recited steps of providing
meals (see claims 9, 10, and 13), the step of coaching (claim 13), and the
providing of meal and exercise plans are not mental steps, nor are they a part
of conventional genetic analysis. App. Br. 14. Appellants also argue that
the steps in the claimed method relating to weight management and the steps
relating to gene analysis are not conventionally combined. Id. Appellants
contend that even if portions of the claims may be routine to one of the two
arts, they are not routine in the other. Id.
Appellants next dispute the Examiner’s finding that the recited panel
of 13 single nucleotide polymorphisms (“SNPs”) is conventional, in either
the art of allelic testing or the art of weight management. App. Br. 15.
According to Appellants, no one has ever collected together this panel of
SNPs for use in this manner, therefore the panel cannot be conventional. Id.
Appellants contend that, whereas testing of individual genes might
encompass a natural principle, a specific collection of 13 has never been
shown to be a natural principle. Id.
Appellants argue further that the particular scoring system, score
summation, cutoff values, and the provision of specific diet and exercise
plans based on those threshold values, constitute a highly specific analytical
framework that is not mental, nor is it a part of conventional genetic
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analysis, as confirmed by the Examiner’s failure to cite any prior art. App.
Br. 15. Appellants further dispute the Examiner’s finding that Examiner
asserts that measuring, looking, computers, and data entry all constitute
mental steps that fail to add significantly more to the claimed method. App.
Br. 15-16.
Appellants therefore contend that the entirety of Examiner’s
§101 analysis lies in ignoring anything related to gene testing as a natural
principle, and then ignoring or dismissing the remaining language as
conventional or a mental step, without having to provide any proof that they
are conventional or mental, even though expressly challenged to do so. App.
Br. 16. Appellants contend that such alleged unsupported argumentation is
insufficient to support a conclusion that the claims are directed to
nonstatutory subject matter and are therefore unpatentable. Id.
The Examiner responds that the only positive step recited in the
claims is isolating and processing DNA to determine the presence or absence
of specific SNPs. Ans. 9. The Examiner finds Appellants’ Specification,
discloses that isolating and processing these polymorphism positions were
known in the prior art, and encompass only the detection of naturally-
occurring genetic positions. Id. The Examiner therefore finds that isolating
and identifying SNPs already occurring in the body of the client is merely
the detection of a phenomenon of nature. Id.
The Examiner finds the claims do not recite any additional elements
or steps that add anything significant to the judicial exception. Ans. 9. The
Examiner finds the claims do not recite any new or innovative method for
obtaining genetic variants, or of assigning and summing scores. Id.
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The Examiner further finds that step a of claim 1 can be interpreted as
a mental step because the measuring values could be done by looking at the
patient (to identify gender and ethnicity) or looking at a scale (to measure
weight). Ans. 9. The Examiner also finds steps c—e are directed to mental
steps, because these steps merely assign, sum, and select. Id. The Examiner
further finds that claims 9, 10, and 13 are not drawn to any specific
computer, and therefore the steps or inputting and outputting are considered
as using of a generic computer. Id. Further, with respect claim 9 and 13,
which also recite the steps of ’’providing prepared meals or components” and
“providing detailed exercise plans and/or individual coaching” and
“coaching said client,” the Examiner finds that providing meals
encompasses placing individuals on diet plans, which, as Appellants’
Specification discloses, have been previously shown to have correlations
with weight or BMI factors. Id. at 10.
The Section 101 analytical framework set forth by the Supreme Court
in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct.
1289 (2012), has been summarized by our reviewing court in Ariosa
Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015):
First, we determine whether the claims at issue are directed to a patent-
ineligible concept. If the answer is yes, then we next consider the elements
of each claim both individually and “as an ordered combination” to
determine whether additional elements “transform the nature of the claim”
into a patent-eligible application. The Supreme Court has described the
second step of this analysis as a search for an “inventive concept”—i.e., an
element or combination of elements that is “sufficient to ensure that the
patent in practice amounts to significantly more than a patent upon the
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[ineligible concept] itself.” Ariosa, 788 F.3d at 1375 (citing Mayo, 132 S.Ct.
at 1297-98, 1294).
Appellants’ claims are directed to a process, i.e., a “method of weight
management” and thus fall within the scope of patentable subject matter
under Section 101.3 We next determine whether the claim is directed to a
judicially-created exception to Section 101, viz., an abstract idea, a law of
nature, or a phenomenon of nature. See Mayo, 132 S.Ct. at 1297. Claim 1
requires the practitioner of the method to measure the client’s weight, height,
waist circumference, hip circumference, body mass index, waist-to-hip ratio,
and determine the client’s gender and ethnicity. Claim 1 further requires the
practitioner to isolate and process the client’s DNA to determine the
presence or absence of exercise- and diet-related polymorphisms at specific
locations in the client’s genome.
We find that these steps are all directed to the measurement or
determination of phenomena of nature. An individual’s physical properties,
gender, and ethnicity are inherent to that individual and are present whether
measured or not. Moreover, claim 1 requires no specific method of
performing these well-understood measurements, nor does it recite any
novel method of measuring or determining them. Consequently we find
these steps of measuring the client’s properties are directed to a phenomenon
of nature, measured by ways that are commonplace activities in the field of
endeavor. Similarly, identifying the genetic sequence of polymorphisms in
3 Section 101 states: “Whoever invents or discovers any new and useful
process ... composition of matter, or any new and useful improvement
thereof, may obtain a patent therefor, subject to the conditions and
requirements of this title.”
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an individual’s genome that are naturally-occurring and “known to be
associated with weight gain” (see Spec. 6), by means that are already
commonly known and practiced in the art, is similarly directed to a
phenomenon of nature, viz., the relationship between the expression of
certain polymorphisms and the genetically-based tendency towards weight
gain. See, e.g., Association for Molecular Pathology v. Myriad Genetics,
Inc., 133 S.Ct. 2107, 2117 (2013). We therefore proceed to the second stage
of the analysis to determine whether the remaining limitations add
significantly more to the claim so as to recite an inventive concept. See
Ariosa, 788 F.3d at 1375.
The remaining claims require assigning and summing scores based on
the determined nucleotide polymorphisms and, optionally, the measurements
made of the individual, and then selecting and implementing a diet plan and
an exercise plan based on the results. Additional steps of providing meals
(see claims 9, 10, and 13), the step of coaching (claim 13) are recited in the
respective claims. Finally, claims 10 and 13 recite the use of a general-use
computer (or processor) in analyzing the results.
We find the Supreme Court’s holdings in Mayo and in Alice Corp. v.
CLS Bank International, 134 S.Ct. 2347 to be instructive in our analysis of
Appellants’ claims. In Mayo, the patent at issue also set forth a law 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. 132 S.Ct. at 1296. The Supreme Court found that
these additional steps consisted of well-understood, routine, conventional
activity already engaged in by the community of practitioners, and that those
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steps, when viewed as a whole, added nothing significant beyond the sum of
their parts taken separately. Id. at 1298.
The remaining steps recited in Appellants’ claims involve calculating
and summing various values arising from the measurements made by the
practitioner and devising a diet and/or exercise plan based upon those
measurements. With respect to the calculating and summing steps,
Appellants’ Specification states that: “[A]n improved weight management
algorithm is desired that is more tailored to an individual’s genetic profile
and how it governs their responses to macro and micro nutrients.” Spec. 4.
Appellants’ Specification discloses such an algorithm that assigns values to
the various polymorphisms (i.e., “gene scores”) and calculates a summed
score. Spec. 11—20. The algorithm is then used to determine a diet and/or
exercise plan for the client. Spec. 22—27. The Supreme Court has
consistently held that algorithms are also unpatentable as being directed to
abstract ideas. See Alice, 134 S.Ct. 2355 (citing Gottschalk v. Benson, 409
U.S. 63, 71-72 (1972); Parker v. Flook, 437 U.S. 584, 59A-595 (1978)).
Furthermore, the recited steps of determining values via the algorithm
disclosed in the Specification are such that they could be performed mentally
or with a paper and pencil by a skilled artisan, and are therefore “directed to
a mental process ... ‘a subcategory of unpatentable abstract ideas.’” Alice',
see Summary Judgment Order, 78 F.Supp.3d at 961, 963. We consequently
conclude that the steps of the claims reciting the calculating and summing
steps are directed to mental processes and are thus directed to an abstract
idea within the judicial exception to Section 101.
Finally, with respect to the steps of devising a diet and/or exercise
plan based upon the calculations and summations obtained from the prior
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steps, we find that the devising of diets and exercise plans constitute little
more than are “well-understood, routine, conventional activities]”
previously known to the industry. Mayo, 132 S.Ct., at 1294; Alice, 134 S.Ct.
2359. Similarly, the use of a generic computer to perform the calculations as
well as providing food in conformance with the scheduled dietary plan are
also well-understood and routine in the weight management field of
endeavor and do not add significantly more to the claim so as to render the
claim patentable. See Alice, 134 S.Ct. 2359 (use of a generic computer to
perform generic computer functions does not add significantly more to a
patent claiming a judicial exception).
We consequently agree with, and adopt, the Examiner’s conclusion
that Appellants’ claims are unpatentable under 35 U.S.C. § 101 as being
directed to nonstatutory subject matter, and we affirm the Examiner’s
rejection of the claims.
DECISION
The Examiner’s rejection of claims 1, 2, 9, 10, and 13 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)(1). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
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