Ex Parte Haines et al

Patent Trial and Appeal Board

Feb 23, 2017

12925221 (P.T.A.B. Feb. 23, 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.
12/925,221 10/13/2010 Robyn Aylor Haines AYLOR-US4 8371
7590 02/24/2017
Robert B. Aylor
9502 Bluewing Terrace
Cincinnati, OH 45241
EXAMINER
WEARE, MEREDITH H
ART UNIT PAPER NUMBER
3735
MAIL DATE DELIVERY MODE
02/24/2017 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte ROBYN AYLOR HAINES and
ROBERT BENSON AYLOR
____________________

Appeal 2016-002832
Application 12/925,221
Technology Center 3700
____________________

Before JENNIFER D. BAHR, WILLIAM A. CAPP, and
SEAN P. O’HANLON, Administrative Patent Judges.

BAHR, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Robyn Aylor Haines and Robert Benson Aylor (Appellants) appeal
under 35 U.S.C. § 134(a) from the Examiner’s decision rejecting claims 21–
40, which are the only claims pending in the application. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

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THE CLAIMED SUBJECT MATTER
Claim 21, reproduced below, is illustrative of the claimed subject
matter.
21. A method for determining the condition of a living
entity comprising the steps of analyzing at least one material
given off from said living entity using at least one multivariate
analytical test method that is either vapor phase mass
spectrometry, nuclear magnetic resonance spectrometry, or both
vapor phase mass spectrometry and nuclear magnetic
resonance spectrometry to provide test results and then
comparing those results to reference sets comprising the
test results from the same multivariate analytical test method or
methods used to analyze the said material given off from said
living entity on either the same entity at a time when the entity's
condition is known, or the results from the same multivariate
analytical test method or methods on one or more
reference individuals or reference populations of similar entities
having a known condition, the comparison of the said test results
from the said living entity with the said reference sets being
accomplished using a digital expression of the said test results
and the reference sets, a computer, and pattern recognition
software, and then determining by using said comparison if:
a. there is a change in the condition of said individual entity,
b. which of said reference populations results are most similar to
the results from said individual entity, or both a. and b.

REJECTIONS
I. Claims 21–40 stand rejected under 35 U.S.C. § 101 as directed to a
judicial exception (i.e., a law of nature) without significantly
more.1
II. Claims 21–23, 25–30, 32, 34, 37, 38, and 40 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Fletcher (US 4,003,257,

1 This is a new ground of rejection made in the Examiner’s Answer. Ans. 2.
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iss. Jan. 18, 1977) and Braun (US 7,101,340 B1, iss. Sept. 5,
2006).
III. Claims 24, 31, 35, and 36 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Fletcher, Braun, and Mirov
(US 2007/0064748 A1, pub. Mar. 22, 2007).
IV. Claim 33 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Fletcher, Braun, and Butler (US 2005/0245835 A1, pub. Nov.
3, 2005).
V. Claim 39 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Fletcher, Braun, and Appel (Lawrence J. Appel et al., A
Clinical Trial of the Effects of Dietary Patterns on Blood Pressure,
336 New Eng. J. Med. 16:1117, 1117–1123 (1997)).

DISCUSSION
Rejection I—Patent Eligibility under 35 U.S.C. § 101
The Supreme Court has set forth “a framework for distinguishing
patents that claim laws of nature, natural phenomena, and abstract ideas
from those that claim patent-eligible applications of those concepts.” Alice
Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2355 (2014) (citing Mayo
Collaborative Servs. v. Prometheus Labs, Inc., 566 U.S. 66, 72–73 (2012)).
According to the Supreme Court’s framework, we must first determine
whether the claims at issue are directed to one of those concepts (i.e., laws of
nature, natural phenomena, and abstract ideas). Id. If so, we must secondly
“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.” Id. The Supreme
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Court characterizes the second step of the 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 [ineligible concept] itself.’” Id. (brackets in original)
(quoting Mayo, 566 U.S. at 72–73).
With respect to the first step, the Examiner explained:
The pattern of VOCs in the sampled material(s) is a result of
natural processes occurring in the living entity, and is therefore
naturally dependent on the entity's condition (as acknowledged
by Appellant in the originally filed specification, pg. 10, lines
8-15). The claimed method utilizes this relationship between
patterns of VOCs in a material given off from an entity and the
condition of the entity, which itself exists in principle apart from
any human action, and is thus, like the claims in Mayo, directed
toward a law of nature.
Ans. 3.
The Examiner correctly determined that claims 21–40 are directed to
laws of nature—namely, the relationship between the VOCs (i.e., volatile
organic compounds) in a material given off from a living entity and the
condition of that living entity. As explained in Appellants’ Specification,
“[v]olatile materials are created as a result of natural processes in living
entities.” Spec. 10:8. Further, the condition or health of living entities
affects the natural processes in such living entities. This is also a law of
nature. Thus, as also explained in Appellants’ Specification, “the results of
multivariate analytical tests [such as vapor phase mass spectrometry tests]
on . . . samples of such volatile materials . . . collected from a living entity
can provide useful information relative to the health of that living entity.”
Id. at 10:9–11. Just as the relationship at issue in Mayo was “a consequence
of the ways in which thiopurine compounds are metabolized by the body—
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entirely natural processes,” Mayo, 566 U.S. at 77, so too is the correlation
here between the VOCs in a material given off from a living entity and the
condition of that living entity a consequence of naturally occurring
processes. Appellants’ claimed method merely analyzes data by exploiting
that relationship (a law of nature). Accordingly, the claims are directed to a
law of nature.
Appellants argue that “[p]rior to [Appellants’] invention, there was no
appreciation of the correlation that could be found between patterns found in
the data provided by the specifically identified analytical methods and any
disease or condition.” Reply Br. 4. This argument is not persuasive because
evidence in the record contradicts this contention. See, e.g., Fletcher 4:58–
61, 8:20–37; Braun 3:60–65, 10:37–50. Moreover, even assuming the
correlation were newly discovered by Appellants, patent claims focusing on
a newly discovered fact about human biology have been held patent-
ineligible subject matter as being directed to laws of nature. See, e.g.,
Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1373–74, 1376
(Fed. Cir. 2015); Genetic Techs Ltd. v. Merial LLC, 818 F.3d 1369, 1376
(Fed. Cir. 2016). Whether appreciated prior to Appellants’ discovery or not,
the correlation is nonetheless a law of nature.
Having determined that the Examiner correctly determined that the
claims are directed to laws of nature in accordance with the Supreme Court’s
framework, we turn next to the question of whether the Examiner erred in
applying the second step—namely, determining that the additional
elements/steps recited in the claims considered both individually and as an
ordered combination do not transform the nature of the claim into a patent-
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eligible application. On the record before us, we answer this question in the
negative.
Referring to the second step, “[p]urely ‘conventional or obvious’
‘[pre]-solution activity’ is normally not sufficient to transform an
unpatentable law of nature into a patent-eligible application of such a law.”
Mayo, 566 U.S. at 79 (second brackets in original) (citing Parker v. Flook,
437 U.S. 584, 590 (1978)).
Appellants contend that the claimed method involves “specific
analytical methods” and that “[t]he value of the output of the claimed
analytical methods per se has never been appreciated.” Reply Br. 4.
However, as correctly determined by the Examiner, the step of analyzing
using vapor phase mass spectrometry and/or nuclear magnetic resonance
spectrometry involves
technology [that] is conventional, well-known, and routine in the
art, and the step is recited at a high level of generality, without
any limit to: what the analyzing can comprise; the manner in
which the vapor phase mass spectrometry and/or nuclear
magnetic [resonance] spectrometry are used in the analyzing;
what type of results are produced, etc.
Ans. 4.; see Spec. 9:11–17 (admitting that an instrument for performing such
analysis is commercially available); Fletcher 8:20–37 (disclosing several
analytical instruments/techniques, including a mass spectrometer and
nuclear magnetic resonance spectrometry, known in the art for analyzing
collected organic volatiles), 4:58–61 (disclosing using the output of such
analytical techniques on body fluids by “comparing a profile of the organic
volatiles with standard profiles for the detection and monitoring of metabolic
disorders”).
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“[C]omparing one thing to another” is an abstract idea. See Blue
Spike, LLC v. Google Inc., No. 14-CV-01650-YGR, 2015 WL 5260506
(N.D. Cal. Sept. 8, 2015), aff’d, No. 2016-1054, 2016 WL 5956746 (mem)
(Fed. Cir. Oct. 14, 2016). The Examiner also determined that the
“comparing step is likewise recited at a high level of generality” and “is not
limited to any particular type of pattern recognizing algorithm,” and there
are no limits “placed on what types of ‘conditions’ the reference individuals
or populations are known to have.” Ans. 4. As also correctly determined by
the Examiner, the “computer” used in the “comparing” step is merely a
general purpose computer manipulating digital data (i.e., a digital expression
of the test results and reference sets). Id. As explained by the Examiner,
“[t]he computer is recited at a high level of generality and performs the basic
functions of a computer, in this case, comparing test results to reference data
using highly generic software, that would be needed to apply the judicial
exception via computer.” Id.
Appellants assert that the claimed method differs from that in Mayo in
that “[a] doctor could not perform the task in the present application by
taking the data and finding patterns in the data mentally.” Reply Br. 3.
According to Appellants, the facts in Mayo “were very simple and
everything involved in the claimed subject matter had been done before by
doctors acting in their normal practices.” Id. Appellants’ assertion amounts
to unsupported attorney argument and, thus, is entitled to little, if any,
weight. In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). Moreover,
Appellants’ Specification discloses that, as an alternative to maintaining the
data from the individual and reference sets in digital form and using a
computer and pattern recognition software, “a health care professional
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makes a determination of the individual’s health using the data, its
comparison with available reference sets, and the other information and
observations obtained in the normal course of treatment. E.g., the method is
carried out by a doctor.” Spec. 34:7–11. Appellants’ Specification also
discloses that “[s]ince the comparison of so much information is time
consuming, it is highly desirable” that the test method provide the results in
machine-readable (digital) form, “that the operation of the analytical testing
apparatus be done using a computer program in machine-readable form to
avoid human variables,” and “that the comparison of results be done using a
computer and pattern recognition software.” Spec. 23:7–11 (emphasis
added). These disclosures contemplate that the comparison could be done
by a doctor without a computer, albeit perhaps less efficiently and/or
accurately than with a computer. Further, the “striking visual difference
between the chromatographic profiles of the urine sample of a normal or
healthy human being and that of the diabetic” described in column 13, lines
11–14 of Fletcher and illustrated in Figure 5 of Fletcher further suggests that
the comparison called for in Appellants’ claim 21 could be performed
mentally.
Moreover, even accepting Appellants’ premise that a doctor could not
perform the task disclosed in the present application by taking the data and
finding patterns in the data mentally, this would not be dispositive of patent
eligibility because “the inability for the human mind to perform each claim
step does not alone confer patentability.” FairWarning IP, LLC v. Iatric
Sys. Inc., 839 F.3d 1089, 1098 (Fed. Cir. 2016). As our reviewing court has
explained, “the fact that the required calculations could be performed more
efficiently via a computer does not materially alter the patent eligibility of
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the claimed subject matter.” Bancorp Servs., L.L.C. v. Sun Life Assur. Co. of
Can. (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012). Thus, the fact that the
comparison of the test data to the reference sets could be performed more
quickly or efficiently via a computer does not materially alter the patent
eligibility of Appellants’ claims.
Even when the steps of claim 21 are considered as an ordered
combination, they do not add anything significant to the laws of nature that
are not already present when the steps are considered individually. In other
words, the claimed method does nothing more than instruct the practitioner
to exploit the natural relationship between volatiles given off by a living
entity and the condition or health of that entity by employing conventional
and routine analysis techniques and a general purpose computer to compare
test results to reference data using highly generic software. Appellants have
not disclosed any new or inventive analysis instrument or technique or
computer software to perform the claimed method; instead, Appellants
employ a commercially available instrument (“the Gerstel ChemSensor 4440
Chemical Sensor system”), functioning in a conventional manner, with a
general purpose computer, to perform the analyzing and comparing steps of
claim 21. Spec. 9:11–16.
Appellants argue that “applying the judicial exception requires that
someone already knew what needed to be done” and “[t]he prior art does not
teach what is recited in the claims and [Appellants] have argued against
what is presumed to be the closest possible art.” Reply Br. 5. This line of
argument is unavailing because, as the Supreme Court has stated, “[t]he
‘novelty’ of any element or steps in a process, or even of the process itself, is
of no relevance in determining whether the subject matter of a claim falls
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within the § 101 categories of possibly patentable subject matter.” Diamond
v. Diehr, 450 U.S. 175, 188–89 (1981). Moreover, as explained in more
detail below, the Examiner determined that the subject matter of claims 21–
40 would have been obvious and Appellants fail to apprise us of error in
those determinations.
For the above reasons, we agree with the Examiner that the additional
elements/steps recited in claim 21, both individually and as an ordered
combination, do not transform the nature of claim 21 into a patent-eligible
application.
With regard to the Examiner’s determination that the remainder of
Appellants’ claims “do not include additional elements that are sufficient to
amount to significantly more than the judicial exception” (Ans. 5),
Appellants argue that “[t]he limitations in the dependent claims are clearly
not based on . . . ‘law of nature’ factors’” and “are well known in general,
but not as part of the practice of this invention.” Reply Br. 6. Appellants
“submit that the dependent claims relate to advantages and modifications
that could not be ‘obvious’ as applied to the invention prior to the disclosure
of the present method.” Id. Appellants’ arguments do not dispute the
Examiner’s findings that “[a]dditional steps of the dependent claims simply
append well-understood, routine and conventional activities previously
known to the industry, specified at a high level of generality to the judicial
exception and/or add insignificant post-solution activity to the judicial
exception.” Ans. 4–5.
For the above reasons, Appellants’ arguments do not apprise us of
error in the Examiner’s determination that claims 21–40 are directed to
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patent-ineligible subject matter. Accordingly, we sustain the rejection of
claims 21–40 under 35 U.S.C. § 101.
Rejection II—Obviousness based on Fletcher and Braun
In contesting this rejection, Appellants present separate arguments for
claim 21, claims 23 and 26, claim 27, claim 29, claim 32, claim 34, claim
38, and claim 40. Appeal Br. 3–13. Appellants do not present any separate
arguments for patentability of claims 22, 28, 30, and 37 apart from claim 21,
from which they depend. Id. Thus, these claims stand or fall with claim 21.
See 37 C.F.R. § 41.37(c)(1)(iv). Appellants likewise do not present any
separate arguments for patentability of claim 25 apart from claim 23, from
which it depends. Thus, claim 25 stands or falls with claim 23. We address
separately the arguments presented for claims 23 and 26, claim 27, claim 29,
claim 32, claim 34, claim 38, and claim 40.
Claims 21, 22, 28, 30, and 37:
Appellants allege error in the Examiner’s finding that Braun discloses
pattern recognition software. Appeal Br. 3, 6; see Final Act. 4; Ans. 11. In
response, the Examiner construes “pattern recognition” in accordance with a
dictionary definition “as ‘the process by which a computer, the brain, etc.,
detects and identifies structures in data or in visual images or other sensory
stimuli.’” Ans. 11. The Examiner finds that Braun’s disclosure of
“producing a ‘profile’ (alternatively referred to as a ‘template,’ or ‘pattern’)
representative of a patient’s condition or representative of the presence of a
particular compound or set of compounds (col. 9, lines 1-5)” and comparing
these profiles/patterns “to known reference set profiles/patterns to classify
the individual’s profile based on match/non-match characteristics (col. 8,
lines 36-53)” satisfies the Examiner’s cited definition of “pattern
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recognition” and “is carried out through software.” Id. Thus, the Examiner
finds that “the computer program disclosed by Braun ‘to produce a template
or pattern representative of a patient’s condition or representative of the
presence of a particular computer or set of compounds’ reasonably
encompasses ‘pattern recognition software.’” Id. The Examiner further
points out that this disclosure by Braun is consistent with the description of
pattern recognition in Appellants’ Specification. Id.
Appellants’ Specification describes “[p]attern recognition and
clustering software” as “capable of differentiating and grouping samples
according to their unique mass spectral pattern or ‘fingerprint.’” Spec. 9:21–
23. The Specification also describes use of a computer with pattern
recognition software for comparing patterns of many volatile materials to the
same type of information derived from the same entity or similar entities
having known conditions. Id. at 6:1–5. Further, “pattern recognition” is
defined in IEEE 100 The Authoritative Dictionary of IEEE Standards Terms
(7th ed. 2000) as “(1) The identification of shapes, forms, or configurations
by automatic means” or “(2) (image processing and pattern recognition)
The analysis, description, identification, and classification of objects or other
meaningful regularities by automatic or semiautomatic means.”
Accordingly, the Examiner’s construction of “pattern recognition software”
is consistent with the use of that terminology in Appellants’ Specification
and with the conventional use of that terminology in the art.
Braun discloses storing data from the spectroscopic analyzer in a
database in computer 124 and comparing that data (i.e., “[t]he data resulting
from the analysis”) “to a database of spectroscopic breath profiles
characteristic of one or more medical conditions” to alert “the user to a
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‘match’ or ‘nonmatch.’” Braun 3:8–13, 4:55–56, 6:51–55, 8:42–47. Braun
also discloses combining the output of multiple tests using pattern
recognition methods and techniques to produce a template or pattern. Id.
9:1–34. We have considered Appellants’ arguments on pages 3 and 6 of the
Appeal Brief and on pages 16–17 of the Reply Brief, but they do not
persuasively explain why Braun’s disclosure of producing templates or
patterns using pattern recognition and comparing the spectroscopic breath
profile for a patient to spectroscopic profiles characteristic of one or more
medical conditions does not satisfy the claimed step of comparing the test
results from the spectroscopy analysis to test results from other
spectroscopic analysis using a computer and pattern recognition software.
Appellants argue that Fletcher requires generation of profiles of
volatile organic compounds, rather than using the “raw results” of the
analytical test method, in contrast to Appellants’ invention, which does not
require identification of compounds. Appeal Br. 5; see also Reply Br. 15.
Even assuming that Fletcher processes the raw data from its spectrometry
analysis to generate profiles of organic compounds identified in the sample
to produce processed test results, before comparing those processed test
results to similarly produced test results from spectrometry analysis of
materials from the same or other living entities, we agree with the Examiner
(Ans. 6) that the argued distinction is not set forth in claim 21. Claim 21
does not restrict the form of the claimed “test results” to raw, unprocessed
spectrometric data; rather, claim 21 specifies only that the test results are
provided by one or both of vapor phase mass spectrometry and nuclear
magnetic resonance spectrometry. Profiles of organic compounds identified
in the spectrometry data are test results provided by the spectrometry test
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method. Appellants’ discussion emphasizing the claim language “those
results” and “then” on page 12 of the Reply Brief does not apprise us of
error in the Examiner’s construction of claim 21.
Moreover, as the Examiner points out, “Fletcher discloses at least one
example of the use of ‘profiles of organic volatiles’ without identifying any
particular ‘important’ compounds to distinguish between healthy/normal
individuals and those having a disease and/or progression of a disease over
time.” Ans. 9, 22 (citing Fletcher 15:10–19). Further, even assuming that
Fletcher’s disclosure were limited to examples in which compounds are
identified, as Appellants assert, Appellants’ argument attacks Fletcher
individually, rather than as combined with Braun. “Non-obviousness cannot
be established by attacking references individually where the rejection is
based upon the teachings of a combination of references.” In re Merck &
Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (citing In re Keller, 642 F.2d 413,
425 (CCPA 1981). The Examiner reasons that “there is still sufficient
motivation to utilize ‘pattern recognizing’ software [as taught by Braun] in
order to establish reference profiles, each characteristic of a disease, by
which to compare the identified list of compounds for the purposes of
determining presence/absence and/or progression/regression of a disease.”
Ans. 23. Appellants do not specifically identify any flaw in the Examiner’s
reasoning in this regard.
Appellants contend that because Fletcher discloses only gas
chromatography and Braun teaches only light absorption chromatography,
“[t]he software that would be used by Braun would not have the capability
of detecting patterns in the data from Fletcher.” Reply Br. 15. This
contention mischaracterizes Fletcher and Braun, neither of which restricts its
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teachings to one particular type of detector. See Fletcher 8:20–37
(disclosing a multitude of suitable detectors, including mass spectrometer,
infrared or ultra violet spectroscopy, magnetic resonance analysis, and the
like); Braun 3:3–13 (disclosing, in addition to a laser spectrometer or cavity
ring down spectrometer, any “other sensitive spectroscopic analyzer” as a
suitable analyzer). Moreover, the contention presumes that the same
particular software contemplated by Braun for use with laser spectrometry
would be bodily incorporated into Fletcher’s method for use with mass
spectrometry or nuclear magnetic resonance spectrometry. “It is well-
established that a determination of obviousness based on teachings from
multiple references does not require an actual, physical substitution of
elements.” In re Mouttet, 686 F.3d 1322, 1332 (Fed. Cir. 2012) (citations
omitted); see also Keller, 642 F.2d at 425 (stating “[t]he test for obviousness
is not whether the features of a secondary reference may be bodily
incorporated into the structure of the primary reference”).
Appellants argue that Fletcher’s observation of a “striking visual
difference between the chromatographic profile of urine samples of a
healthy human being and that of the diabetic” (Fletcher 13:10–14) shows
that “the results are not subjected to pattern recognition software, but merely
graphed” and that “this example would teach away from any need for using
such software if a simple inspection is sufficient.” Reply Br. 21–22. We do
not agree with Appellants that Fletcher teaches away from using a computer
and pattern recognition software. In fact, to the contrary, as noted by the
Examiner (Final Act. 4), Fletcher recognizes that mass spectrometry
provides “an excellent fingerprint or profile of a chemical substance” and
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that “[t]his technique lends itself to computerizing with all its inherent
advantages.” Fletcher 1:24–29.
Appellants additionally argue that the Altomare reference (D.F.
Altomare et al., Exhaled volatile organic compounds identify patients with
colorectal cancer, Br J Surg 100:144–150 (2013), hereinafter “Altomare”) is
evidence of unobviousness. Appeal Br. 21, 42 (Evidence App.). More
specifically, Appellants contend that Altomare, which was published after
Appellants’ “priority date,” teaches that combination of Appellants’
analytical methods with patterning software is sufficient “after the selection
of what compounds that are present might be of interest” and, thus, does not
appreciate that raw data could be used within the test results for comparison
with similar patterns within reference sets. Id. at 24. Appellants further
emphasize that the references cited in the footnotes of Altomare likewise do
not recognize the use of raw data in the comparison. Id. at 24–25.
Appellants contend that the footnotes in Altomare “show that even the more
recent efforts to solve [Appellants’] problem did not utilize [Appellants’]
approach despite the clear benefits that it provides,” thereby establishing
long-felt need. Id. at 26; see also Reply Br. 22. Appellants’ argument and
proffered evidence is not commensurate in scope with claim 21, which, as
already pointed out above, does not require that raw data be used in the
comparison without first identifying what compounds might be of interest.
Moreover, establishing long-felt need requires objective evidence of
three elements. First, the need must have been a persistent one that was
recognized by those of ordinary skill in the art. Orthopedic Equip. Co. v. All
Orthopedic Appliances, Inc., 707 F.2d 1376, 1382 (Fed. Cir. 1983); see also
In re Gershon, 372 F.2d 535, 539 (CCPA 1967). Second, the long-felt need
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must not have been satisfied by another before the invention by the
applicant. Newell Companies v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed.
Cir. 1988) (“[O]nce another supplied the key element, there was no long-felt
need or, indeed, a problem to be solved.”) Third, the invention must in fact
satisfy the long-felt need. In re Cavanagh, 436 F.2d 491 (CCPA 1971).
“[L]ong-felt need is analyzed as of the date of an articulated identified
problem and evidence of efforts to solve that problem.” Texas Instruments,
Inc. v. U.S. Int’l Trade Comm’n, 988 F.2d 1165, 1178 (Fed. Cir. 1993).
While Altomare and the references cited in the footnotes alluded to in
Appellants’ Appeal Brief may establish a long-felt need for improved
simplicity and performance of breath testing techniques as a screening tool
for various medical conditions, Appellants do not point to evidence in the
record before us that establishes either that the contributions of Braun do not
satisfy such need or that Appellants’ claimed invention in fact satisfies such
need.
For the above reasons, Appellants fail to apprise us of error in the
Examiner’s determination that the subject matter of claim 21 would have
been obvious. Accordingly, we sustain the rejection of claim 21 and claims
22, 28, 30, and 37, which fall with claim 21, under 35 U.S.C. § 103(a) as
unpatentable over Fletcher and Braun.
Claims 23, 25, and 26:
Appellants argue that “[i]f one were to make a digital record of
Fletcher’s results, it would be of the compounds, not the raw data.” Appeal
Br. 8. This argument is predicated on a distinction between “raw data” and
the profiles of organic volatiles resulting from the analysis of body fluids
disclosed in Fletcher that is not set forth in claims 23 and 26. Thus, for
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essentially the same reasons as the similar argument addressed above in
connection with claim 21, this line of argument fails to show error in the
rejection of claims 23, 25, and 26.
Appellants also contend that “Braun’s method does not generate
independent data points but rather generates a single result (a spectrum) so
that there is no possibility of finding any other pattern than the one that is
generated by Braun’s apparatus” and that “Fletcher’s apparatus first
generates the raw data in digital form but then either uses all of the data or
requires a further step of converting the raw data to determine what
compounds are present.” Id. (underlining omitted). Thus, according to
Appellants, “[t]here is no reason taught for determining patterns within the
data for a patient and then finding a similar pattern within one or more of
reference sets of data.” Id.
This line of argument is not persuasive, as Fletcher expressly
discloses “comparing a profile of the organic volatiles with standard profiles
for the detection and monitoring of metabolic disorders” (Fletcher 4:58–61)
and Braun discloses spectroscopic analysis of gases in expired breath “for
obtaining a patient’s breath concentration profile,” storing “spectroscopic
breath analysis profiles” in a database stored within a memory component of
a computer, and using “a computer program for comparing the obtained
patient’s breath profile to the stored database of spectroscopic breath
profiles” (Braun 2:42–51). The profiles disclosed by Fletcher and Braun for
comparison using a computer program comprise multiple data points and
reference data sets, which would be stored or converted to digital form for
manipulation by the computer program.
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For the above reasons, Appellants fail to apprise us of error in the
rejection of claims 23, 25, and 26. Accordingly, we sustain the rejections of
claims 23, 25, and 26 under 35 U.S.C. § 103(a) as unpatentable over
Fletcher and Braun.
Claim 27:
Appellants take issue with the Examiner’s determination that it would
have been obvious to modify Fletcher’s method by “storing the results of the
analyses with at least the identity of the specific entity in order to provide
the predictable results of associating test results with the correct patient,
thereby increasing the accuracy of the determination of progress and the
efficacy of the entity’s treatment” (Final Act. 7). Appeal Br. 8–9.
Appellants contend that “[p]atient privacy could . . . result in the desire to
avoid associating the identity with the results in the same data base absent
some reason relating to obtaining the diagnosis.” Id. at 9.
This argument is unpersuasive. The Examiner has articulated a reason
for associating the test results with the patient’s identity—namely, to
facilitate associating those results with the correct patient for comparison to
results from subsequent samples taken from the same patient to assess
progress and efficacy of the patient’s treatment. Final Act. 7 (citing Braun
7:24–51).
Appellants also argue that “Braun would not suggest that anyone use
any analytical method except that of Braun,” and, thus, “would not suggest
storing Fletcher’s results for any reason.” Appeal Br. 9. This argument
appears to be predicated on Appellants’ position that the teachings of
Fletcher are restricted to gas chromatography and those of Braun are
restricted to light absorption chromatography, which, as discussed above, is
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not correct. Thus, for the same reasons set forth above, this line of argument
does not show error in the rejection.
Accordingly, we sustain the rejection of claim 27 under 35 U.S.C.
§ 103(a) as unpatentable over Fletcher and Braun.
Claim 29:
Appellants contend that the Examiner’s rejection “does not address
the copyrighting of a database.” Appeal Br. 9. This contention is correct,
but it does not show error in the rejection because claim 29 does not require
copyrighting of a database. Rather, claim 29 requires “at least one of: (1)
the step in which at least one database or reference set is copyrighted . . . or
(2) the step of providing a standard food diet for test subjects to minimize
differences resulting from diets.” Appeal Br. 39 (emphases added) (Claims
App.). The Examiner’s rejection addresses alternative (2)—providing a
standard food diet to minimize differences related to diet. Final Act. 7–8.
Appellants submit that “there is no suggestion of any reason given for
incurring the extra work and expense of providing a standard food diet” and
contend that “[o]ne does not add complexity without some reason for
expecting a benefit and there is no such benefit disclosed in either [Fletcher
or Braun].” Appeal Br. 9. The Examiner points to Braun’s disclosure that
“an individual’s diet can affect acute changes in the individual’s breath
profile (col. 8, lines 54-62)” and determines that “one of ordinary skill in the
art would recognize that providing a standard diet would reduce such acute
changes and increase accuracy of subsequent diagnoses from the test
results.” Ans. 15. The Examiner adds that one of ordinary skill in the art
would appreciate from Braun’s disclosure of “monitoring disease
progression and/or treatment efficacy (col. 8, lines 23-36)” and suggestion
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that “treatment of an individual can include diet control (col. 7, lines 52-62)”
that “providing a standard diet treatment would permit monitoring the
efficacy of said diet on the individual’s disease.” Id. The Examiner notes
that “Braun discloses providing a diet as a form of treatment . . . and further
suggests acute changes in data samples can be influenced by diet, which
would suggest . . . that controlling an individual’s diet can facilitate
controlling said acute changes, and thereby provide a more accurate
diagnosis and/or determination of disease progression or regression.” Id.
at 16.
Appellants do not dispute the Examiner’s finding with respect to the
teachings of Braun, but they challenge the reasonableness of expensive and
difficult diets and take issue with the Examiner’s reasoning that the
teachings of Braun regarding the influence of a patient’s diet on test results
would suggest that controlling an individual’s diet can facilitate controlling
acute changes, thereby providing more accurate diagnoses or determinations
of disease progression/regression. Reply Br. 17–18.
Appellants’ arguments fail to persuade us the Examiner’s reasoning
lacks rational underpinnings. Appellants do not direct our attention to any
evidence supporting their assertion that the standard diets are necessarily
expensive and difficult; as such, the assertion is entitled to little, if any
weight. Moreover, even assuming such controlled diets are expensive
and/or difficult, the Examiner correctly points out that such considerations
are not dispositive of nonobviousness. Ans. 15 (citing Advisory Action
dated Sept. 26, 2014 (p. 11)). “The fact that the motivating benefit comes at
the expense of another benefit . . . should not nullify its use as a basis to
modify the disclosure of one reference with the teachings of another.
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Instead, the benefits, both lost and gained, should be weighed against one
another.” Winner Int'l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8
(Fed. Cir. 2000). We agree with the Examiner that a person having ordinary
skill in the art would have readily appreciated from Braun’s teachings of the
influence of an individual’s diet on breath profile, as well as the use of diet
to treat some diseases or conditions, that controlling diet would be a useful
means of minimizing diet related influences that might skew the results,
thereby permitting more accurate/normalized diagnoses and monitoring of
disease progression or regression. “A person of ordinary skill is also a
person of ordinary creativity, not an automaton.” KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 421(2007). A conclusion of obviousness must be
supported by explicit findings and analysis establishing an apparent reason
to combine the known elements in the manner required in the claim at issue.
Id. at 418. However, “the analysis need not seek out precise teachings
directed to the specific subject matter of the challenged claim, for [the
Examiner] can take account of the inferences and creative steps that a person
of ordinary skill in the art would employ.” Id.
For the above reasons, Appellants’ arguments do not apprise us of
error in the rejection of claim 29 under 35 U.S.C. § 103(a) as unpatentable
over Fletcher and Braun, which we, thus, sustain.
Claim 32:
Claim 32 depends from claim 21 and further recites that “the entity is
an animal.” Appeal Br. 40 (Claims App.). The Examiner’s rejection of this
claim is grounded in part on the Examiner’s construction of the term
“animal” as encompassing humans. See Final Act. 8 (stating, “Fletcher . . .
teaches the entity is an animal (e.g., humans; . . . urine samples from
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humans, human breath, etc.)”); Ans. 16–17 (construing “animal” in
accordance with the definition “a living organism which feeds on organic
matter, typically having specialized sense organs and a nervous system and
able to respond rapidly to stimuli; any living creature, including man”).
Appellants take issue with the Examiner’s construction as being
inconsistent with their Specification. Appeal Br. 10. According to
Appellants, the treatment of the terms “human” and “animal” in the
Specification “as being separate” and the “separation of the two terms” in
original claim 19 “clearly indicates a separation of the scopes of their
definitions.” Id. Appellants contend that “[t]he term ‘animal’ can be used to
define only non-human animals.” Id. Appellants additionally cite a
different dictionary definition (i.e., “[i]n ordinary or non-technical use: any
such living organism other than a human being”) than the one cited by the
Examiner in support of their position. Id. (underlining omitted).
The Examiner states that “Appellant has not set forth a particular
definition of ‘animal’ that specifically excludes humans” and, thus,
maintains that the dictionary definition of “animal” cited by the Examiner,
which encompasses “any living creature, including man,” “is the broadest
reasonable definition of the term of record.” Ans. 16–17. In response,
Appellants submit that “[w]hile it may be necessary for an applicant acting
as his own lexicographer to fully define the scope of a brand new term, it is
not necessary when all that is required is the choice between two accepted
definitions of the term.” Reply Br. 18.
Appellants’ Specification uses the terms “humans” (or “people”) and
“animals” separately in numerous places. See, e.g., Spec. 1:12, 1:18, 2:26,
5:22–23, 6:22, 12:7, 25:21, 26:32, 28:13. Thus, we agree with Appellants
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that this suggests that the terms “animals” and “humans” have different
scopes. However, this does not mean that the two terms are mutually
exclusive, and Appellants do not point to any disclosure in their
Specification that effectively defines the term “animals” as excluding
“humans.” The Specification states that “‘[a]nimals’ especially comprises
pets, food animals, laboratory animals, etc.” Spec. 1:15–16. However, this
open-ended language does not exclude other unnamed entities, such as
humans, from the scope of “animals.” Moreover, the Specification states
that “[s]amples of the breath of individuals from healthy populations of
humans, dogs, cats, cows, horses, etc. are analyzed . . . to create reference
sets for each different animal.” Spec. 32:7–9. This sentence treats humans
as falling within the scope of animals.
Thus, after considering the use of the terms “humans” and “animals”
in Appellants’ Specification and the positions of both the Examiner and
Appellants, we perceive no error in the Examiner’s construction of the term
“animal” in claim 32, under its broadest reasonable interpretation, as
encompassing a human. Accordingly, Appellants fail to apprise us of error
in the rejection of claim 32 under 35 U.S.C. § 103(a) as unpatentable over
Fletcher and Braun, which we, thus, sustain.2

2 Although not specifically relied upon by the Examiner, we note that
Fletcher explicitly addresses the “need for a relatively simple, fast,
inexpensive and reproducible method for detecting diseases, determining the
progress of disease, and measuring effectiveness of treatment of disease in
humans and animals.” Fletcher 2:8–12 (emphasis added). Thus, even if the
term “animal” in claim 32 were construed as excluding humans, Fletcher
seemingly contemplates application of its teachings to non-human animals,
as well as humans.
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Claim 34:
Claim 34 recites “[a] method for monitoring the health of many
entities for public health purposes comprising the method of claim 21.”
Appeal Br. 41 (Claims App.). In addressing this claim, the Examiner
acknowledged that Fletcher does not explicitly teach “monitoring the health
of many entities for public health purposes,” but found that Fletcher teaches
that “the disclosed method lends itself to massive screening for disease.”
Final Act. 8 (citing Fletcher 2:8–13). In light of this teaching, the Examiner
determined:
[I]t would have been obvious . . . to utilize[e] the method of
Fletcher for monitoring the health of many entities for public
health purposes in order to provide the predictable results of
providing a relatively simple, fast, inexpensive and reproducible
method for detecting diseases, determining the progress of
disease, and measuring effectiveness of treatment of disease in
humans and animals.
Id.
Appellants counter that “[t]he concept of using either of the analytical
methods for public health reasons is not obvious” and that “[c]onsidering the
value of this use, it is surprising that the references fail to mention the use if
it is obvious.” Appeal Br. 11. Appellants add that the portion of Fletcher
relied upon by the Examiner “does not state that Fletcher’s method does
provide [the benefits cited therein] or suggest how that would occur.” Reply
Br. 18. According to Appellants, “[a]t most, it suggests that Fletcher’s
method might be useful in pursuing that goal.” Id.
Appellants’ argument is not persuasive. A person having ordinary
skill in the art would have recognized that Fletcher contemplates applying
the method disclosed therein in a widespread manner to broad segments of
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the population to screen for and monitor disease and to assess efficacy of
treatments for disease; the benefits to public health from such screening are
self-evident.
Appellants also assert, without further elaboration, that “the
combination of the references is not supported.” Appeal Br. 11. We
understand this to be a reiteration of the argument that because Fletcher and
Braun disclose different analytical testing techniques, the teachings of these
references are not applicable to one another. This argument is unpersuasive,
for the reasons discussed above.
Appellants’ arguments fail to apprise us of error in the rejection of
claim 34. Accordingly, we sustain the rejection of claim 34 under 35 U.S.C.
§ 103(a) as unpatentable over Fletcher and Braun.
Claim 38:
The Examiner found that Fletcher discloses using the disclosed
method on one or more entities under controlled conditions over time during
treatment to assess the progress and effect of such treatment. Final Act. 9
(citing Fletcher 14:60–15:7). The Examiner acknowledged that Fletcher
“does not explicitly teach the ‘treatment’ comprises food or medicine,” but
found that “it is well known in the art that medical treatment often includes a
restrictive diet or medicine regime.” Id. Thus, the Examiner determined “it
would have been obvious . . . to modify the method of Fletcher to evaluate[]
the effect of food or medicine using the method of claim 21 in order to
provide the predictable results of determining the efficacy of the food or
medicine on the medical condition of the living entity.” Id.
Appellants do not specifically dispute the Examiner’s findings or
reasoning; instead, Appellants submit, in essence, that the benefit of doing
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so would have been so great that “it would already have been adopted if it
was ‘obvious.’” Appeal Br. 11; see also Reply Br. 18–19. This argument is
unpersuasive. As pointed out by the Examiner, Fletcher explicitly teaches
use of the method to monitor the progress of treatment, but simply does not
specify that the treatment involves food or medicine. Final Act. 8. The
Examiner additionally points out that “Braun discloses providing a treatment
including a diet (i.e., food) and discloses monitoring disease progression or
regression for an individual over time via the individual’s exhaled breath.”
Ans. 18 (citing Braun 7:24–39). According to the Examiner, this “provides
. . . an accurate, timely, and painless indicator of the health of the individual
(i.e., ‘without resorting to double blind tests involving large numbers of
people,’ as asserted by Appellant[s]).” Id. (citing Braun 1:25–40). As
already noted, Appellants do not dispute the Examiner’s finding that
restrictive diets and medicine regimens were well-known medical
treatments. Thus, applying the concept taught by Fletcher to monitor the
progress of treatments involving consumption of food or medicine involves
no innovation, and would have been obvious to one of ordinary skill in the
art.
Appellants do not apprise us of error in the rejection of claim 38 under
35 U.S.C. § 103(a) as unpatentable over Fletcher and Braun, which we, thus,
sustain.
Claim 40:
In contesting this rejection, Appellants essentially merely reiterate
their argument that the teachings of Fletcher and Braun are not combinable
because they disclose different analytical techniques. Appeal Br. 12. This
line of argument is not convincing for the reasons set forth above.
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Appellants submit that “[t]here is nothing that suggests that the method of
Fletcher should replace the method of Braun in the disclosure of Braun.” Id.
This argument is unavailing because it does not address the rejection
articulated by the Examiner, which does not propose to replace the method
of Braun with the method of Fletcher in Braun’s disclosure.
Accordingly, Appellants do not apprise us of error in the rejection,
and, thus, we sustain the rejection of claim 40 under 35 U.S.C. § 103(a) as
unpatentable over Fletcher and Braun.
Rejection III—Obviousness based on Fletcher, Braun, and Mirov
Claim 24:
Appellants argue that “Mirov is not properly combined with Fletcher”
and “clearly would not suggest any modification of Fletcher and would
support the necessity of determining what compounds are present as an
essential intermediate step.” Appeal Br. 14. These lines of argument are not
persuasive of error, for the reasons set forth above in discussing the rejection
of claim 21.
Appellants also submit that Mirov lacks disclosure “of combining
individual results into a generic result that represents all entities having the
same situation.” Id. In paragraph 110, cited by the Examiner (Final Act.
10), Mirov suggests use of “the ‘optical nose’” technology, “which is
capable of detecting all organic compounds present in exhaled breath,” for
“quantifying a large number of known and novel biomarkers for lung cancer,
thereby creating specific recognition patterns or ‘fingerprints’ for the
disease.” The Examiner’s finding that this entails “combining reference sets
from a group of individuals sharing a known similar condition (e.g., lung
cancer)” appears to be grounded on the Examiner’s understanding “that test
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results from at least two similar entities would be required to recognize and
create a ‘pattern’ as disclosed by Mirov/Fletcher as modified.” Final Act.
10–11. This reasoning by the Examiner has rational underpinnings, in that
recognition patterns for a disease (such as lung cancer) cannot be established
or created from a single data point (i.e., test results from a single patient)
but, rather, reflect something that happens in a regular and repeated way
(i.e., is observed in patients having that disease but not in patients not having
that disease). As such, the Examiner’s finding reflects a reasonable
inference drawn from the teachings of Mirov, Braun, and Fletcher.
Nevertheless, in the alternative, the Examiner adds that “it would have been
obvious . . . to further modify the method of Fletcher with utilizing multiple
reference sets of similar individuals (e.g., sharing the same condition) in
order to provide the predictable results of facilitating the generation of a
pattern specific to the similar condition.” Id. at 11. Appellants do not
present persuasive argument explaining why the Examiner’s reasoning lacks
rational underpinnings.
For the above reasons, Appellants fail to apprise us of error in the
rejection of claim 24 under 35 U.S.C. § 103(a) as unpatentable over
Fletcher, Braun, and Mirov, which we, thus, sustain.
Claim 31:
Appellants argue that Mirov’s “spectrum recognition algorithm is not
the pattern recognition software of the present invention.” Appeal Br. 15
(citing Mirov ¶ 63). According to Appellants, a spectrum recognition
algorithm “is merely a program for comparing a specific pattern to a library
of spectra and preferably requires knowledge of what compounds are
markers” and pattern recognition software “looks for similar patterns in two
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separate data sets where there may be no matches and certainly where there
is no library of specific spectra that are markers in [Appellants’] method.”
Id. at 15–16. Appellants’ description of a spectrum recognition algorithm
and pattern recognition software does not cogently explain why a computer-
based spectrum recognition algorithm for identifying and quantifying
molecules in absorption spectra is not “pattern recognition software” as
described in Appellants’ Specification. See Spec. 9:21–23 (describing
“[p]attern recognition and clustering software” as “capable of differentiating
and grouping samples according to their unique mass spectral pattern or
‘fingerprint’”), 6:1–5 (describing use of a computer with pattern recognition
software for comparing patterns of many volatile materials to the same type
of information derived from the same entity or similar entities having known
conditions). The distinction emphasized by Appellants appears to be
directed not to the algorithm or software itself, but to the contents of the data
reference sets processed by the algorithm or software (i.e., spectra of
identified biomarker compounds versus spectra of unspecified mixtures of
compounds).
However, the Examiner did not rely specifically on the “spectrum
recognition algorithm” disclosure in paragraph 63 of Mirov in addressing the
pattern recognition software limitation. Rather, taking into account Mirov’s
teaching to create “‘specific recognition patterns’ or ‘fingerprints’ based on
quantifying a large number of known and novel biomarkers for a disease” in
paragraph 110, the Examiner explains that “one of ordinary skill in the art
would readily recognize that software that creates ‘specific recognition
patterns’ from data including all organic compounds present in exhaled
breath reasonably comprises pattern recognition software.” Ans. 20.
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Appellants point out that Mirov does not explicitly mention “using
software to create (find) patterns.” Reply Br. 20. Appellants are correct that
paragraph 110 of Mirov does not mention using software, but, rather, merely
suggests an application for the disclosed technology. However, Appellants’
observation amounts to an attack on paragraph 110 of Mirov in isolation,
rather than in combination with the teachings of Fletcher, Braun, and the
remainder of Mirov, all of which teach the use of computers and pattern
recognition software for processing the type of data addressed in these
references. See, e.g., Fletcher 1:28–30 (noting that “[t]his technology lends
itself to computerization with all its advantages,” given the huge databases
of organic compounds); Braun 8:36–47 (disclosing use of a computer to
compare spectroscopic breath profile test data to a database of such profiles);
id. 9:1–35 (describing pattern recognition techniques for permitting “a wider
range of conditions or compounds [to be] identified by correlating the data
pattern or changes in the data pattern over time”).
For the above reasons, Appellants do not apprise us of error in the
rejection of claim 31.
We note, moreover, that step “i” recited in claim 31 need not be
performed to satisfy claim 31. Rather, claim 31 may be satisfied by
performing any one of (i.e., “at least one of”) steps “i” through “xv.”
Appeal Br. 40 (Claims App.). In addressing claim 29, the Examiner
determined:
It would have been obvious to one of ordinary skill in the art at
the time of the invention to modify the method of Fletcher with
providing a standard food diet for the test subjects in order to
provide the predictable results of reducing changes in the
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determined test result due to diet, thereby increasing the accuracy
of subsequent diagnosis from the test results.
Final Act. 8 (citing Braun 8:54–62).
For the reasons set forth above in discussing the rejection of claim 29,
Appellants fail to apprise us of error in this determination. Thus, even
assuming arguendo that the Examiner’s determination that it would have
been obvious in view of the combined teachings of Fletcher, Braun, and
Mirov to perform step “i” of claim 31 in Fletcher’s method is deficient, this
does not show that the Examiner’s ultimate conclusion of obviousness of the
subject matter of claim 31 is incorrect.
For the above reasons, we sustain the rejection of claim 31 under
35 U.S.C. § 103(a) as unpatentable over Fletcher, Braun, and Mirov.
Claims 35 and 36:
Appellants’ arguments on pages 17 and 18 of the Appeal Brief
contesting the rejection of claims 35 and 36 essentially reiterate arguments
already addressed above, and fail to apprise us of error in the rejection for
the reasons set forth above.3 Accordingly, we sustain the rejection of claims
35 and 36 under 35 U.S.C. § 103(a) as unpatentable over Fletcher, Braun,
and Mirov.
Rejection IV—Obviousness based on Fletcher, Braun, and Butler
In contesting this rejection, Appellants merely reiterate the arguments
already addressed above. See Appeal Br. 19 (stating only that “[f]or the

3 We note, additionally, that Appellants’ arguments directed to “pattern
recognition software” are not germane to the rejection of claim 35, which
incorporates only the “at least one multivariate analytical test method
according to claim 21,” and not the comparing step of claim 21, and, thus,
does not require digital test results, a computer, or pattern recognition
software. Appeal Br. 41 (Claims App.).
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reasons given before, [Appellants] take issue with this rejection” and that
“Fletcher is not properly modified by Braun”). For the same reasons set
forth above in addressing claims 21 and 32, these arguments also fail to
apprise us of error in the rejection of claim 33 under 35 U.S.C. § 103(a) as
unpatentable over Fletcher, Braun, and Butler, which we, thus, sustain.
Rejection V—Obviousness based on Fletcher, Braun, and Appel
In contesting this rejection, Appellants reiterate the arguments already
addressed above. See Appeal Br. 20 (stating that “[f]or the reasons given
hereinbefore, Fletcher and Braun are not properly combined”). For the same
reasons set forth above, these arguments also fail to apprise us of error in the
rejection of claim 39.
Appellants add that “[t]here is no indication in any reference that
using any other analytical method as disclosed in this application could
provide any benefit over and above the benefit obtained by the specific
measurements in the Appel reference.” Id. This argument does not identify
error in the rejection articulated by the Examiner because the rejection does
not propose to modify the analytical method or specific measurements used
in Appel, nor does the rejection propose to use spectroscopic analysis in
monitoring conditions which do not lend themselves to spectroscopic
analysis. Rather, the rejection proposes to incorporate the broad concept of
performing and repeating testing on groups of individuals having an
abnormal health condition and following different diet regimens to
determine the effects of diet on the abnormal health condition, as taught by
Appel, into the method of Fletcher (as modified in view of Braun) “in order
to provide the predictable results of determining the effect of a particular
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diet and/or medication on medical conditions capable of being diagnosed by
spectroscopic profile analysis.” Final Act. 17.
For the above reasons, Appellants do not apprise us of error in the
rejection of claim 39 under 35 U.S.C. § 103(a) as unpatentable over
Fletcher, Braun, and Appel, which we, thus, sustain.

DECISION
The Examiner’s decision rejecting claims 21–41 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). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED