Ex Parte Haines et al

Patent Trials and Appeals Board

Jun 28, 2019

12925221 - (D) (P.T.A.B. Jun. 28, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
12/925,221
7590
Robert B. Aylor
FILING DATE
10/13/2010
06/28/2019
9502 Bluewing Terrace
Cincinnati, OH 45241
FIRST NAMED INVENTOR
Robyn Aylor Haines
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
AYLOR-US4 8371
EXAMINER
WEARE, MEREDITH H
ART UNIT PAPER NUMBER
3791
MAIL DATE DELIVERY MODE
06/28/2019 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
Appeal2019-000481
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 61-
79.1 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM.
1 The claims addressed by the Examiner in the Final Action contained claim
numbering informalities, in that the newly presented claims began with
claim 60, but should have started with claim 61, as claims 1--60 had been
canceled. See Final Act. 2. Further, Appellants skipped "75" in numbering
that claim set. See id. Appellants corrected the claim numbering problems
subsequent to the Final Action. See Ans. 2. Thus, the rejections applied to
claims 60--74 and 76--79 in the Final Action now apply to claims 61-79,
respectively, before us in this appeal. See id.
Appeal2019-000481
Application 12/925,221
THE CLAIMED SUBJECT MATTER
Claims 61 and 79 are independent. Claim 61, reproduced below, is
illustrative of the claimed subject matter.
61. A method for aiding and improving the speed of
determining the condition of a subject living entity at a
particular time comprising:
1. a step of collecting at least one headspace material
comprising volatile material or materials, either directly from
around said subject living entity, or from around one or more
samples of non-volatile material obtained from said subject
living entity;
2. a step of analyzing said headspace material using a
headspace-mass spectrometry test method to provide test results
that are the mass spectral channel signals (m/z) after electron-
ionization of the said volatile material in said headspace
material; and
3. a step of comparing said test results from said
subject living entity at a particular time to at least one of:
A. similar reference test results created when
said headspace-mass spectrometry test method is used
on corresponding headspace material from said subject
living entity at a time when said subject living
entity's condition was known: or
B. similar reference test results created when
said headspace-mass spectrometry test method is used
on corresponding headspace material obtained from at
least one reference individual living entity or
reference population of individual living entities where
each reference individual living entity or individual
living entity in a reference population of living entities
shares one or more basic characteristics with said subject
living entity, including similar genetic background,
allergies, family history of susceptibility to diseases, and
diet and also has at least one known or unknown
condition of interest, to provide reference set test
results representative of said known or unknown
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condition or conditions, all of the said test results being
stored in digital form and said comparison of the test
results from the said subject living entity at said
particular time with at least one of the said similar
reference test results being accomplished by data mining
software to determine at least one of:
a. based on the reference test results A., at
least one of whether:
1. there is a change in the condition of
the said subject living entity, or
2. what change has occurred in the
condition of the said subject living entity: or
3. what is responsible for any
change that has occurred in the condition of
said subject living entity
b. based on the reference test results B.,
which reference set or sets, of test results,
obtained from at least one of said reference set
living entities or population of living entities
contains one or more patterns that match one or
more patterns found within the test results from the
subject living entity at said particular time.
REJECTIONS
I. Claims 61-79 stand rejected under 35 U.S.C. § 112, second
paragraph, as being indefinite.
II. Claims 61-79 stand rejected under 35 U.S.C. § 101 as being
directed to a judicial exception without significantly more.
III. Claims 61-72, 74, 75, 78, and 79 stand rejected under
35 U.S.C. § I03(a) as unpatentable over Braun (US 7,101,340 Bl,
issued Sept. 5, 2006), Fletcher (US 4,003,257, issued Jan. 18,
1977), and Hitt (US 2003/0004402 Al, published Jan. 2, 2003).
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IV. Claim 73 stands rejected under 35 U.S.C. § I03(a) as unpatentable
over Braun, Fletcher, Hitt, and Butler (US 2005/0245835 Al,
published Nov. 3, 2005).
V. Claims 76 and 77 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Braun, Fletcher, Hitt, and Appel (Lawrence J.
Appel et al., A Clinical Trial of the Effects of Dietary Patterns on
Blood Pressure, 336 N Engl J Med 1117 (1997)).
DISCUSSION
Rejection I-Indefiniteness2
Principles of Law Pertaining to Indefiniteness
"As the statutory language of 'particular[ity]' and 'distinct[ness]'
indicates, claims are required to be cast in clear-as opposed to ambiguous,
vague, indefinite-terms." In re Packard, 751 F.3d 1307, 1313 (Fed. Cir.
2014) (citation omitted).
Id.
At the same time, this requirement is not a demand for
unreasonable precision. The requirement, applied to the real
world of modem technology, does not contemplate in every
case a verbal precision of the kind found in mathematics. Nor
could it do so in a patent system that actually works, in practice,
to provide effective protection for modem-day inventions.
Rather, how much clarity is required necessarily invokes some
standard of reasonable precision in the use of language in the
context of the circumstances.
2 Appellants' claim amendments subsequent to the Final Action have
overcome many, but not all, of the rejections under 35 U.S.C. § 112, second
paragraph. See Ans. 2-3.
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Claims, when read in light of the specification, must "reasonably
apprise those skilled in the art both of the utilization and scope of the
invention" using language "as precise as the subject matter permits." Id. In
determining whether a claim is definite under 35 U.S.C. § 112, second
paragraph, "[t]he USPTO, in examining an application, is obliged to test the
claims for reasonable precision according to [this principle]." Id.
"[I]f a claim is amenable to two or more plausible claim constructions,
the USPTO is justified in requiring the applicant to more precisely define the
metes and bounds of the claimed invention by holding the claim
unpatentable under 35 U.S.C. § 112, second paragraph, as indefinite." Ex
parte Miyazaki, 89 USPQ2d 1207, 1211 (BP AI 2008) (precedential).
Analysis
The Examiner determined that the terminology "headspace material"
in the claims is unclear because gases, such as breath ( one of the possible
samples identified in the Specification), "do not appear to have a 'headspace
material' according to [the] art-recognized definition" of "headspace" "as
the gaseous volume above a liquid or solid, e.g., in a closed container."
Final Act. 3. Thus, according to the Examiner, "it is unclear if the
'headspace material' as recited in claim 6 [ 1] is intended to be limited to [the]
art-recognized definition noted above (e.g., the gaseous volume above a
liquid or solid), or is intended to include gaseous samples, such as breath,
obtained directly from the living entity." Id.
Appellants explain that, in accordance with "standard terminology,"
gaseous samples "are collected from the space around a subject for use in
analysis and then converted into a liquid, placed in a container having a
headspace, and the sample for analysis [is] taken from that headspace."
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Appeal Br. 4. Thus, Appellants contend that their use of the terminology
"headspace material" in connection with breath samples is consistent with
"standard terminology." Id. The Examiner does not specifically dispute that
persons of ordinary skill in the art would understand "headspace material" in
this context in association with gaseous samples such as breath, much less
provide evidence to the contrary.
Accordingly, we do not sustain the rejection of any of the claims as
being indefinite on the basis that "headspace material" is unclear.
The Examiner determined that the use of the term "similar"
throughout the claims renders the claims indefinite because this "is a relative
term which renders the claims indefinite[, t ]he term 'similar' is not defined
by the claim[s], the [S]pecification does not provide a standard for
ascertaining the requisite degree, and one of ordinary skill in the art would
not be reasonably apprised of the scope of the invention." Final Act. 3.
Thus, according to the Examiner, "it is unclear what test results and/or
genetic backgrounds fall within the scope of 'similar' results/backgrounds."
Id.; see also id. at 6 ( addressing the terms "similar" and "basically similar"
in claim 68).
Appellants submit that the term "'similar' in the context of the
claim[ s] clearly refers to the need that the reference results should be
obtained from reference individuals having both the same identified
condition and, preferably similar characteristics so as to make the
comparison as meaningful as possible." Appeal Br. 5. Appellants add that
"[t]he invention's scope is not defined by the degree of similarity and there
is ample disclosure relating to how to improve similarity," and that, "[b ]y its
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nature, 'similar' is variable with various degrees of similarity being better
depending on the degree of similarity." Id.
Appellants acknowledge that the term "similar," in the context of their
claims, has some degree of variability, and that the degree of similarity may
affect the accuracy of the results of the comparisons made. However,
Appellants' Specification does discuss extraneous variables that should be
minimized or eliminated to the degree possible, depending on what the
investigator hopes to learn from the tests. See Spec. 10:26-12: 18. It may
not be possible to assign a precise, quantitative definition to the term
"similar" that would apply in all cases in the context of the claimed
invention. However, a person having ordinary skill in the art would have a
reasonable understanding of the degree to which variables such as diet,
geography, age, gender, ethnic background, and the like might influence test
results, especially with respect to particular conditions or diseases. Thus, we
are not persuaded that a person having ordinary skill in the art would be
unable to ascertain, with reasonable precision, taking into account the types
of conditions or diseases that would be of concern for a subject living entity,
given the characteristics ( diet, geography, age, gender, ethnic background,
observed state of health at time of testing, etc.) of the subject living entity,
how similar the reference tests or populations must be to those of the subject
living entity in order to fall within the intended scope of the claimed
invention.
Accordingly, we do not sustain the rejection of any of the claims on
the basis that the term "similar" is unclear.
The Examiner determined that the term "corresponding" in clause B
of claim 61 is indefinite because "it is unclear to what the headspace
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material corresponds, at least one reference living entity, a reference
population of individual entities, etc." Final Act. 4. The Examiner explains
that one reasonable interpretation of "corresponding" is that the "headspace
material" of clause B of claim 61 "corresponds to the recited 'at least one
reference individual living entity[' or] 'reference population of individual
living entities,"' and another reasonable interpretation is that the headspace
material collected from the reference individual/population corresponds to
the headspace material collected from the subject living entity in the sense of
having to be of the same type of material, e.g., breath samples. Ans. 6. The
Examiner also determined that the term "corresponding" in claim 65 is
likewise unclear. Final Act. 5.
Appellants respond that "[ c ]learly the sample from a patient will
correspond ( share the same essential parameters) with both the reference
entity and entities in order for the comparison to be relevant." Reply Br. 4. 3
The Examiner has identified an ambiguity, namely, two reasonable
interpretations of the term "corresponding" in claim 61, and Appellants'
response is unavailing to resolve that ambiguity. Accordingly, we sustain
the rejection of claims 61 and 65, as well as claims 62---64 and 66-78, which
depend from claim 61, and, thus, inherit the aforementioned ambiguity. 4
3 The Reply Brief does not include page numbers. Thus, for convenience,
we refer herein to the pages of the Reply Brief as if numbered consecutively
beginning with the page captioned "REPLY BRIEF BEFORE THE BOARD
OF PATENT APPEALS AND INTERFERENCES" as page 1.
4 Notably, the Examiner did not reject independent claim 79, which recites
"using corresponding reference headspace samples taken from at least one of
... said subject living entity at a time when the said subject living entity's
condition was known" or at least one reference living entity, on this
particular basis. See Final Act. 2-7; Ans. 4--7; Appeal Br. 41--42 (Claims
App.). In the event of future prosecution of the claimed subject matter, the
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The Examiner determined that the limitation "specific time" in
claim 62 renders claim 62 indefinite because it is unclear whether "specific
time" is the same as the "particular time" recited in claim 61, or whether this
limitation is intended to recite additional testing at a different time from the
"particular time" of claim 61. Final Act. 4. In response, Appellants submit
that "[s]ince the action is the same at either time, 'specific' and 'particular'
can be used interchangeably," and "[t]here is no difference." Appeal Br. 7.
According to Appellants, "[i]t all depends upon what answer is sought and
what time is selected." Id.
The Examiner states, and we agree, that "[i]f the terms are
interchangeable and/or mean the same thing, the claim(s) should be amended
to use one of 'particular time' or 'specific time' consistently to clarify this
intention." Ans. 7. Appellants state that they "stand ready to make the
change to a consistent term if this rejection is upheld." Reply Br. 5.
For the above reasons, Appellants do not apprise us of error in the
Examiner's determination that the term "specific time" renders claim 62
further indefinite. Accordingly, we sustain the rejection of claim 62 on this
additional basis.
The Examiner additionally determined that, in claim 71, "the
limitation 'a data base herein' (in the limitation labeled 'ii') is indefinite, as
it is unclear to what 'herein' refers." Final Act. 6. Appellants respond that
"the data base 'herein' is any data base that is created as part of the
invention," and that "[t]he term is not limiting in any way." Appeal Br. 10.
In response, the Examiner points out that "there is no recitation of a data
Examiner may wish to consider whether the term "corresponding" in claim
79 renders claim 79 indefinite.
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base being created in the claims prior to the limitation 'adding to a data base
herein' of claim 71, such that it is not readily apparent to what data base(s)
this step refers." Ans. 7.
The Examiner is correct that there is no antecedent basis in claim 71
for a "data base" prior to the "a data base herein" limitation, but claim 71
does reference "a data bank" and "and individual data bank or a central data
bank" prior to the "a data base herein" recitation. Thus, it is not clear
whether "a data base herein" refers to the previously-recited "data bank" or
"individual data bank or ... central data bank" or whether the "adding to a
data base herein" requires a data base distinct from the "data bank" or
"individual data bank or ... central data bank."
Accordingly, we sustain the rejection of claim 71 as indefinite on the
additional basis that the limitation "a data base herein" is unclear.
In summary, we sustain the rejection of claims 61-78 as indefinite as
indicated above, but we do not sustain the rejection of claim 79 as indefinite
on any basis set forth by the Examiner.
Rejection II-Patent Eligibility
Principles of Law Pertaining to Patent Eligibility5
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 long interpreted 35 U.S.C. § 101 to include
implicit exceptions: "[l]aws of nature, natural phenomena, and abstract
ideas" are not patentable. E.g., Alice Corp. v. CLS Bank Int 'l, 573 U.S. 208,
216 (2014).
5 Additional principles of law appear below in the analysis as applicable.
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In determining whether a claim falls within an excluded category, we
are guided by the Supreme Court's two-step framework, described in Mayo
and Alice. Id. at 217-18 ( citing Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66, 75-77 (2012)). In accordance with that framework,
we first determine what concept 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. Kappas, 561 U.S. 593, 611 (2010) ("Claims 1 and 4
in petitioners' application explain the basic concept of hedging, or protecting
against risk.").
Concepts determined to be abstract ideas, and thus patent ineligible,
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 (Gottschalkv. Benson, 409 U.S. 63, 69 (1972)). Concepts
determined to be patent eligible include physical and chemical processes,
such as "molding of rubber products" (Diamond v. Diehr, 450 U.S. 175, 192
(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))).
In Diehr, the claim at issue recited 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 176; see also id. at 191 ("We
view respondents' claims as nothing more than a process for molding rubber
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products and not as an attempt to patent a mathematical formula."). Having
said that, the Supreme Court also indicated 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 tum to the second
step of the Alice and Mayo framework, where "we must 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 ( 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).
"[M]erely requir[ing] generic computer implementation[] fail[ s] to transform
that abstract idea into a patent-eligible invention." Id.
The PTO published revised guidance on the application of§ 101.
USPTO's 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed.
Reg. 50 (January 7, 2019) ("2019 Eligibility Guidance"). Under that
guidance, we first look to whether the claim recites:
( 1) any judicial exceptions, including certain groupings of abstract
ideas (i.e., mathematical concepts, certain methods of organizing
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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)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that
exception into a practical application, do we then look to whether the claim:
(3) adds a specific limitation beyond the judicial exception that are not
"well-understood, routine, conventional" 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 2019 Eligibility Guidance.
Analysis
In contesting the rejection under 35 U.S.C. § 101, Appellants argue
claims 61-79 together. Appeal Br. 10-14. We select claim 61 to decide the
appeal of this rejection, with claims 62-79 standing or falling with claim 61.
See 37 C.F.R. § 41.37(c)(l)(iv) (permitting the Board to select a single claim
to decide the appeal as to a single ground of rejection of a group of claims
argued together).
(1) Does claim 61 recite ajudicial exception?
The Examiner found that claim 61 recites a law of nature, namely, that
there is a correlation between natural processes occurring in the living entity
dependent on the entity's condition, and the pattern of volatile organic
compounds (VOCs) given off from the living entity. Final Act. 8. The
Examiner also found that the claims recite an abstract idea, namely,
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comparing the entity's test results to reference data to determine the living
entity's condition. Id. at 8-9.
Claim 61 recites a step of comparing test results obtained from
headspace-mass spectrometry test method analysis of headspace material
comprising volatile materials from a subject living entity to at least one of
reference test results from the subject living at a time when the subject living
entity's condition was known or reference test results from at least one
reference individual living entity or reference population of individual living
entities. Appeal Br. 37 (Claims App.). Comparing one thing (headspace-
mass spectrometry data from the subject living entity) to another thing
(reference headspace-mass spectrometry data) is an evaluation that can be
performed in the human mind, or with pen and paper. In re BRCAJ &
BRCA2-Based Hereditary Cancer Test Pat. Litig., 774 F.3d 755, 763 (Fed.
Cir. 2014) (concluding that the concept of "comparing BRCA sequences and
determining the existence of alterations" is an "abstract mental process").
Thus, the comparing step of claim 61 is a mental process, which is one of the
groupings of abstract ideas identified in the 2019 Eligibility Guidance.
Claim 61 also recites that the comparing step is performed to
determine at least one of: a. whether there is a change in the condition of the
subject living entity, what change has occurred, or what is responsible for
any change that has occurred in the condition of the subject living entity
(based on a comparison with reference test results from the subject living
entity at a time when the condition of the subject living entity was known) or
b. which reference set, or sets, of test results obtained from at least one
reference living entity or reference population of living entities contains one
or more patterns that match one or more patterns found within the test results
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of the subject living entity (based on a comparison with reference test results
from at least one reference individual living entity or reference population of
individual living entities). Making a determination based on the comparison
is an evaluation, judgment, or opinion as to changes or similarities in
observed patterns in the data, which could be performed in the human mind,
or with pen and paper. Thus, the "to determine" recitation in claim 61 is a
mental process ( a concept which could be performed in the human mind),
which is one of the groupings of abstract ideas identified in the 2019
Eligibility Guidance. See 2019 Eligibility Guidance, 84 Fed. Reg. at 52.
Accordingly, the Examiner correctly determined that claim 61 recites
a judicial exception, namely, an abstract idea.
The aforementioned "to determine" recitation also correlates patterns,
and changes in patterns, in the headspace-mass spectrometry data, created by
amounts and relative amounts of volatile organic materials from the subject
living entity and/or reference living entities, with conditions in the living
entities. See Spec. 10:8-15 (stating that "[v]olatile materials are created as a
result of natural processes in living entities" and "vapor phase mass
spectrometry tests[] provide information about the amounts and relative
amounts of the volatile organic materials created by an entity which then can
be used to assist in the evaluation of the health of the entity" and "can also
provide early warning of mutations in, e.g., diseases, when the pattern
changes"). This correlation, or relationship, is a law of nature, much like the
"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" in Mayo. Mayo, 566 U.S. at 77. The Court in Mayo explained,
"[t]he relation is a consequence of the ways in which thiopurine compounds
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are metabolized by the body----entirely natural processes. And so a patent
that simply describes that relation sets forth a natural law." Id. Similarly, in
claim 61, the relationship between the patterns in the headspace-mass
spectrometry test data of the subject living entity at the particular time and
the headspace-mass spectrometry test data of the subject living entity at a
time when the condition of the subject living entity was known is a
consequence of natural processes in the living entity, and changes in these
patterns is a consequence of changes that can be a sign of a change in the
subject living entity's condition, e.g., disease. Thus, the Examiner also
correctly determined that claim 61 recites a law of nature, which is also a
judicial exception. See Alice, 573 U.S. at 216. Appellants' arguments
disputing that there is a correlation between volatiles and a living entity's
condition are unpersuasive. See Appeal Br. 12-13, 20, 25; Reply Br. 7.
However, we do not go into them in further detail here because, as discussed
above, this recitation is also another judicial exception, namely, an abstract
idea, and our analysis below is predicated on the Examiner's determination
that claim 61 recites an abstract idea.
(2) Does claim 61 recite additional elements that integrate the judicial
exception into a practical application?
Following our Office guidance, having found that cfaim 61 recites a
judicial exception, namely, mental processes, which are abstract ideas, we
are instructed next to determine whether the claim recites "additional
elements [that] integrate the exception into a practical application" (see
MPEP § 2106.05(a}-(c), (e}-(h)). See 2019 Eligibility Guidance, 84 Fed.
Reg. at 54. This evaluation requires us to determine whether an additional
element or a combination of additional elements in the claim applies, relies
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on, or uses the judicial exception in a manner that imposes a meaningful
limit on the judicial exception, such that the claim is more than a drafting
effort designed to monopolize the exception. If the recited judicial
exception is integrated into a practical application, the claim is not "directed
to" the judicial exception.
The additional limitations in claim 61 include a step of collecting at
least one headspace material, either directly from around the subject living
entity or from around one or more samples obtained from the subject living
entity; a step of analyzing the headspace material "using a headspace-mass
spectrometry test method to provide test results that are the mass spectral
channel signals (m/z) after electron-ionization of the said volatile material in
said headspace material"; storing the test results in digital form; and using
"data mining software" to perform the comparing step. See Appeal Br. 37
(Claims App.).
The step of collecting the headspace material is simply a generic step
of data collection, which is insignificant extra-solution activity. See, e.g.,
CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1370 (Fed.
Circ. 2011) ("We have held that mere '[data-gathering] step[s] cannot make
an otherwise nonstatutory claim statutory."' (alterations in original) ( quoting
In re Grams, 888 F.2d 835, 840 (Fed. Cir. 1989))); see also 2019 Eligibility
Guidance, 84 Fed. Reg. at 55 (identifying "add[ing] insignificant extra-
solution activity to the" abstract idea as an example of when an abstract idea
has not been integrated into a practical application).
The step of analyzing the headspace material using a headspace-mass
spectrometry test method is recited in a generic manner, without any
specifics about any particular mass spectrometer used in the method. A
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headspace-mass spectrometer is certainly not a generic computer. However,
our reviewing court has held "consistently ... that claims are not saved from
abstraction merely because they recite components more specific than a
generic computer." BSG Tech LLC v. BuySeasons, Inc., 899 F.3d 1281,
1286-87 (Fed. Cir. 2018) (stating, "the recitation of a database structure
slightly more detailed than a generic database does not save the asserted
claims at step one"); see, e.g, In re TL! Commc 'ns LLC Patent Litig., 823
F.3d 607, 612-13 (Fed. Cir. 2016) (holding claims were directed to an
abstract idea despite the claims' recitation of telephone units and servers);
Content Extraction & Transmission LLC v. Wells Fargo Bank, Nat 'l Ass 'n,
776 F.3d 1343, 1347 (Fed. Cir. 2014) (holding claims were directed to an
abstract idea despite the claims' recitation of a scanner). In essence, the
analyzing step simply provides the mass spectral channel signal data to be
used in the comparing step. There is no indication in the record before us
that the recited headspace-mass spectrometry test method invokes any
assertedly inventive programming, requires any specialized computer
hardware or other inventive computer components, i.e., a particular machine,
or that the claimed invention is implemented using other than generic
headspace-mass spectrometry components to perform generic mass
spectrometry functions. Rather, to the contrary, Appellants' Specification
identifies a commercially-available apparatus ("the Gerstel ChemSensor
4440 Chemical Sensor system") for introducing the headspace material(s),
performing the mass spectrometry, and providing pattern recognition
capability for analyzing the data. Spec. 9:8-26.
Storing data in digital form, and processing data in digital form, is one
of the most basic functions of a computer, and, thus, is insufficient to
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integrate the judicial exception into a practical application. See Alice, 573
U.S. at 225 (describing "electronic recordkeeping" as "one of the most basic
functions of a computer"). Claim 61 recites the data mining software
generically, without any specifics regarding any assertedly inventive
programming or use of any specialized computer hardware or other
inventive computer components to perform the data mining function. See
Content Extraction, 776 F.3d at 1347 (holding ineligible claims drawn
to "1) collecting data, 2) recognizing certain data within the collected data
set, and 3) storing that recognized data in a memory" and stating: "The
concept of data collection, recognition, and storage is undisputedly well-
known. Indeed, humans have always performed these functions. And banks
have, for some time, reviewed checks, recognized relevant data such as the
amount, account number, and identity of account holder, and stored that
information in their records.").
Further, we find no indication in the Specification that the claimed
invention effects a transformation or reduction of a particular article to a
different state or thing. Nor do we find anything of record that attributes any
improvement in computer technology and/or functionality to the claimed
invention or that otherwise indicates that the claimed invention integrates the
abstract idea into a "practical application," as that phrase is used in the 2019
Eligibility Guidance.
Appellants argue that "[t]he claims would not control the use of any
'law of nature' that might exist as required by the rejection" because "[t]hey
would only control the specific limited way of analyzing and using samples
of volatiles taken from around individuals that [ A ]ppellants have disclosed
and claimed." Appeal Br. 13. Appellants misapprehend the controlling
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precedent to the extent they maintain that the claims are patent-eligible
because there is no risk of preemption. The Supreme Court has described
"the concern that drives [the exclusion of abstract ideas from patent eligible
subject matter] as one of pre-emption," Alice, 573 U.S. at 216
( characterizing preemption as a driving concern for patent eligibility is not
the same as characterizing preemption as the sole test for patent eligibility).
However, "[t]he Supreme Court has made clear that the principle of
preemption is the basis for the judicial exceptions to patentability" and "[ fJor
this reason, questions on preemption are inherent in and resolved by the
§ 101 analysis." Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371,
1379 (Fed. Cir. 2015) (citing Alice, 134 S. Ct. at 2354). "[P]reemption may
signal patent ineligible subject matter, [but] the absence of complete
preemption does not demonstrate patent eligibility." Id.
Appellants also argue that claim 61 "defines and utilizes 'significantly
more than the judicial exception' if one exists," in that "[t]he determination
of a relationship between the volatiles from around an individual and a
condition in the prior art depended, when it could be determined, upon the
identity and amount of specific compounds in the volatiles ('markers')."
Appeal Br. 14. Appellants' argument appears to be directed to the
comparing step of claim 61, which, as discussed above, is a mental process,
which is an abstract idea, that is, the judicial exception itself. However, it
could not be clearer from Alice, that under step two of the Mayol Alice
framework, the elements of each claim are considered both individually and
"as an ordered combination" to determine whether the additional elements,
i.e., the elements other than the abstract idea itself, "transform the nature of
the claim" into a patent-eligible application. Alice, 573 U.S. at 217; see
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Mayo, 566 U.S. at 72-73 (requiring that "a process that focuses upon the use
of a natural law also contain other elements or a combination of elements,
sometimes referred to as an 'inventive concept,' sufficient to ensure that the
patent in practice amounts to significantly more than a patent upon the
natural law itself' ( emphasis added)).
For the above reasons, we determine that no additional element or
combination of additional elements in claim 61 applies, relies on, or uses the
judicial exception (mental processes) in a manner that imposes a meaningful
limit on the judicial exception, such that the claim is more than a drafting
effort designed to monopolize the exception. In other words, claim 61 is
"directed to" an abstract idea.
(3) Does claim 61 add any specific limitations beyond the judicial
exception that are not "well-understood, routine, and conventional"
in the field?
Because we determine that claim 61 fails to recite additional elements
that integrate the judicial exception into a practical application, in
accordance with the 2019 Eligibility Guidance, we next consider whether the
claim adds a specific limitation beyond the judicial exception that is not
"well-understood, routine, conventional" in the field or instead "simply
appends well-understood, routine, conventional activities previously known
to the industry, specified at a high level of generality, to the judicial
exception." See 2019 Eligibility Guidance, 84 Fed. Reg. at 56.
Turning first to the step of collecting headspace material, Appellants
admit that "the sampling is a conventional part of sample preparation and is
not part of the essential steps that constitute the invention." Appeal Br. 4
( emphasis added). Similarly, the step of analyzing the headspace material
using a headspace-mass spectrometry method is a well-known, routine, and
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conventional process for analyzing and identifying patterns in volatile
organic compounds. As discussed above, Appellants' Specification
identifies a commercially-available apparatus ("the Gerstel ChemSensor
4440 Chemical Sensor system") for introducing the headspace material( s ),
performing the mass spectrometry, and providing pattern recognition
capability for analyzing the data. Spec. 9:8-26.
As discussed above, storing data in digital form, and using data
mining software to compare the data, amount to using a computer,
performing its most basic functions, to store and process data. There is no
indication in the record before us that the recited data mining software
invokes any assertedly inventive programming, requires any specialized
computer hardware or other inventive computer components, i.e., a
particular machine, or that the claimed invention is implemented using other
than generic computer components to perform generic computer functions.
As for Appellants' argument that claim 61 is an improvement in the
analysis of volatile materials or in the diagnostic process, in that "[t]he
determination of a relationship between the volatiles from around an
individual and a condition in the prior art depended, when it could be
determined, upon the identity and amount of specific compounds in the
volatiles ('markers')" (Appeal Br. 14), any such improvements reside in the
comparing step, which is the judicial exception itself (i.e., the abstract idea,
namely, mental processes). However, as discussed above, the inventive
concept under step two of the Mayo/Alice test cannot be the abstract idea
itself:
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It is clear from Mayo that the "inventive concept" cannot be the
abstract idea itself, and Berkheimer . .. leave[s] untouched the
numerous cases from this court which have held claims
ineligible because the only alleged "inventive concept" is the
abstract idea.
Berkheimer v. HP, Inc., 890 F.3d 1369, 1374 (Fed. Cir. 2018)
(Moore, J., concurring); see also BSG, 899 F.3d at 1290-91 ("Our precedent
has consistently employed this same approach. If a claim's only 'inventive
concept' is the application of an abstract idea using conventional and well-
understood techniques, the claim has not been transformed into a patent-
eligible application of an abstract idea.").
For the reasons discussed above, we find no element or combination
of elements recited in claim 61 beyond the judicial exception that is not
"well-understood, routine, conventional" in the field or that contains any
"inventive concept" or adds anything "significantly more" to transform the
abstract concept into a patent-eligible application. Alice, 573 U.S. at 221.
Accordingly, we sustain the rejection of claim 61, as well as claims 62-79,
which fall with claim 61, under 35 U.S.C. § 101 as being directed to patent-
ineligible subject matter.
Rejection III-Obviousness: Braun, Fletcher, and Hitt
Principles of Law Pertaining to Obviousness6
Rejections on obviousness grounds must be supported by "some
articulated reasoning with some rational underpinning" to combine the
known elements in the manner required in the claim at issue. In re Kahn,
6 Additional principles of law appear below in the analysis as applicable.
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441 F.3d 977, 988 (Fed. Cir. 2006), cited with approval in KSR Int'! Co. v.
Teleflex Inc., 550 U.S. 398,418 (2007).
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR, 550 U.S. at 416.
Claims 61 and 64:
The Examiner found that Braun discloses most of the elements of
claim 61. See Final Act. 11-13. However, the Examiner found that
although "Braun discloses the multivariate analytical test method used to
provide the test results can include any 'sensitive spectroscopic analyzer'
(col. 3, lines 8-13), Braun does not expressly teach the multivariate
analytical test method is headspace-mass spectrometry." Id. at 13.
Additionally, the Examiner found that although "Braun discloses the
'headspace material' can be a gaseous breath sample, Braun does not teach
collecting at least one headspace material comprising volatile material or
materials from around one or more samples of non-volatile material obtained
from said subject living entity." Id. Further, the Examiner found that Braun
"does not teach the comparison is accomplished by data mining software."
Id. at 14.
The Examiner found that Fletcher teaches a similar method
comprising collecting "volatile material either directly from around the
subject living entity (e.g., breath) or from around one or more samples of
non-volatile material obtained from the subject living entity ( e.g., headspace
of urine, saliva, etc.)," and analyzing the material using "headspace-mass
spectrometry, which provides mass spectral channel signals (m/z) after
electron-ionization of the volatiles in the headspace over the sample, to
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provide test results." Id. at 13-14 (citing Fletcher 4:58-5:3; 8:20-37). The
Examiner determined it would have been obvious to modify Braun's method
by "alternatively/additionally collecting the at least one headspace material
from around one or more samples of non-volatile material obtained from
said subject living entity and the multivariate analytical test method
comprising headspace-mass spectrometry," as taught by Fletcher, "in order
to facilitate alternatively/additionally producing a VOC profile
representative of a patient's condition." Id. at 14. According to the
Examiner, "[t]his is a simple substitution of one known sensitive
spectroscopic analyzer and one known biological material comprising
volatile material( s) for another to yield no more than predictable results."
Id.
The Examiner found that Hitt teaches
a method comprising analyzing at least one material given off
from a living entity with mass spectrometry to provide test
results that are the mass spectral channel signals (m/z) (e.g.,
claims 59-60, generating or inputting a normalized data stream
that describes a biological sample; ,r [0019] where the data
stream can include mass spectra data); comparing said test
results from said subject living entity at a particular time to
similar reference test results created when said test method is
used on corresponding material obtained from at least one
reference individual living entity or reference population of
individual living entities where each reference individual living
entity or individual living entity in a reference population of
living entities shares one or more basic characteristics with said
subject living entity, including similar genetic background,
allergies, family history of susceptibility to diseases, and diet,
and also has at least one known or unknown condition of
interest (e.g., ,r [0070]; ,r [0075]; ,r [0077]; etc.) to provide
reference set test results representative of said known or
unknown condition or conditions (e.g., ,r [0018]; elm. 45; etc.),
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all of the test results being stored in digital form and said
comparison of the test results from the said subject living entity
at said particular time with at least one of the said similar
reference test results being accomplished by data mining
software (throughout document, detecting subtle, if not totally
hidden, patterns in the expression of certain molecules in
biological samples that are potentially diagnostic in nature, or
predictive of a biological state) to determine which reference
set or sets, of test results, obtained from at least one of said
reference set living entities or population, of living entities
contains one or more patterns that match one or more patterns
found within the test results from the subject living entity at
said particular time ( claims 59-60, assigning to the sample a
diagnosis based on an identified diagnostic cluster).
Final Act. 14--15.
The Examiner determined it would have been obvious
to modify the method of Braun with the test results being the
mass spectral channel signals (m/z) after electron-ionization of
the said volatile material in said headspace material and the
comparing step being accomplished using data mining software
as taught/suggested by Hitt in order to assess a biological
state(s) of the living entity without prior knowledge of specific
markers or the relationship of molecules present in the
biological sample.
Id. at 15 ( citing Hitt ,r 15).
Appellants argue that Braun's test results "are single lines (spectra)
indicating the amount of absorption of various wave lengths of light" and
that Braun's reference to a "sensitive spectroscopic analyzer" should be
interpreted to be limited to test methods "of the same general type as
Braun's and will involve spectra based on light absorption." Appeal Br. 17.
Appellants' argument attacks Braun individually, and, thus, does not inform
us of error in the rejection. Nonobviousness cannot be established by
attacking the references individually when the rejection is predicated upon a
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combination of prior art disclosures. See In re Merck & Co., 800 F.2d 1091,
1097 (Fed. Cir. 1986) (citing In re Keller, 642 F.2d 413,425 (CCPA 1981)).
We agree with the Examiner that Braun's disclosure of a laser spectrometer
is "a 'particular embodiment[,]' ... rather than a specific requirement of the
disclosed system/method." Ans. 10. As the Examiner points out, although a
laser spectrometer may be the preferred spectroscopic analyzer of Braun,
Braun does not specifically discourage the use of a headspace-mass
spectrometry test method. Id.
Appellants argue that, even if Braun were combined with Fletcher,
"[t]he combination still does not teach [A]ppellants' approach of using
'mass spectral channel signals'" because Fletcher characterizes the invention
disclosed therein as an improved system for analyzing "trace amounts of a
large number of organic volatile compounds." Appeal Br. 17 (quoting
Fletcher 1: 13-15 ( emphasis added)). In response, the Examiner points out,
and Appellants do not specifically dispute, that "mass spectrometry is, by
definition, an analytical technique that ionizes chemical species and sorts the
ions based on their mass-to-charge ratio. Therefore, Fletcher, in disclosing
the use of mass spectrometry, inherently teaches producing mass spectral
channel signals after electron-ionization of the said volatile material in the
collected sample." Ans. 11.
Appellants contend that Hitt's disclosure is limited to "compounds
and possibly parts of compounds." Appeal Br. 18. Appellants argue:
There is no teaching in any of the references that would expand
the "obvious" teaching of Hitt to include a specific use with
respect to any of the claimed intermediate "mass spectral
channel signals data" that is created by the claimed analytical
methods as opposed to studying the molecular structures found
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in the samples. There certainly is no teaching of the use of the
claimed "mass spectral channel signals data" for any purpose.
Id. at 20-21.
This argument is unsound for the reasons set forth on pages 11-12 of
the Examiner's Answer. Hitt emphasizes that the analytical methods
disclosed therein "discover hidden discriminatory biological data patterns ..
. that are subsets of the larger data stream" and that the patterns "can be
defined without any knowledge of the identity or relationship between the
individual data points in the biological data or any knowledge of the identity
or relationship between the molecules in the biological samples." Hitt ,r,r 3,
5; see also id. ,r 15 (reiterating that "[n]o prior knowledge of specific tumor
markers or the relationship of molecules present in the biological sample to
each other is required or even desired"), ,r,r 19, 32, 52, 68 (discussing "high
throughput data stream[s]," such as data streams generated by mass
spectroscopy or mass spectrometry analysis).
For the above reasons, Appellants fail to apprise us of error in the
rejection of claim 61 as unpatentable over Braun, Fletcher, and Hitt.
Accordingly, we sustain the rejection of claim 61, as well as claim 64, for
which Appellants do not present any separate arguments and which, thus,
falls with claim 61, as unpatentable over Braun, Fletcher, and Hitt. See
Appeal Br. 23.
Claim 62:
In contesting the rejection of claim 62, Appellants contend that there
is no disclosure in the prior art "of [ A ]ppellants' 'mass spectral channel
signals'" and that "the collection of the raw data is easier and less time
consuming and when one wants to diagnose a patient there is a clear
advantage in not having to go through the step of determining what
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molecules (usually a substantial number of molecules) are present and in
what amounts." Appeal Br. 22. Appellants add that "Braun is limited to
absorption spectra which are inherently obtained from a single sample," and,
thus, Hitt' s teaching to use populations "would have no relevance in the
method of Braun." Id.
Appellants' arguments are unavailing. Fletcher teaches using
headspace-mass spectrometry, which the Examiner finds, and Appellants do
not specifically dispute, produces "mass spectral channel signals after
electron-ionization of the said volatile material in the collected sample."
Ans. 11. As for relevance to Braun's method, Braun discloses comparison
of test results to reference profiles of a database, but does not disclose how
such reference profiles are created. See Braun 3:29-37; Ans. 13. The
Examiner finds that Hitt teaches a method for creating such a reference
profile. Ans. 13 ( citing Hitt ,r 18). Thus, the modification proposed by the
Examiner is nothing more than the simple substitution of one known element
for another or the mere application of a known technique to a piece of prior
art ready for the improvement. See KSR, 550 U.S. at 417. Further, the
Examiner finds that Hitt teaches a data mining technique that offers the
advantage of not requiring any knowledge of specific molecules or their
relationship prior to creating a reference profile and is less costly and time
consuming to perform. Ans. 13; see Hitt ,r,r 3, 4, 13, 15.
For the above reasons, Appellants do not apprise us of error in the
rejection of claim 62 as unpatentable over Braun, Fletcher, and Hitt, which
we, thus, sustain.
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Claim 63:
Appellants state that they "respectfully disagree" with the Examiner's
statement that Braun as modified in view of Fletcher and Hitt renders
obvious the additional limitations of claim 63, but do not elaborate on why
they disagree or specifically identify any flaw in the Examiner's findings or
reasoning in reaching this conclusion. Appeal Br. 22. This vague statement
of disagreement does not constitute a separate argument for the patentability
of dependent claim 63 pursuant to 37 C.F.R. § 4I.37(c)(l)(iv). See In re
Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) (holding that the Board had
reasonably interpreted 37 C.F.R. § 4I.37(c)(l)(vii) (the predecessor to
§ 4I.37(c)(l)(iv)) as requiring "more substantive arguments in an appeal
brief than a mere recitation of the claim elements and a naked assertion that
the corresponding elements were not found in the prior art"). Accordingly,
for the reasons discussed above in regard to claim 61, we also sustain the
rejection of claim 63 as unpatentable over Braun, Fletcher, and Hitt.
Claims 65 and 66:
In contesting the rejections of claims 65 and 66, Appellants argue that
"[t]here is no basis for modifying Braun by using Hitt's disclosure of
combining results from a reference population," and that "Braun can only
create and use single individual results since each spectrum is of a specific
individual's sample and there is no disclosure of how one would combine
the results of individuals in the context of Braun's method." Appeal Br. 23.
Appellants add that "Braun has already created a pattern" and, thus, "[t]here
would be no need to combine results from Braun's method to obtain a
pattern that already exists." Id.
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This line of argument is similar to that presented in contesting the
rejection of claim 62, and fails to apprise us of error for the reasons
discussed above in regard to claim 62. Braun discloses comparison of test
results to reference profiles of a database, but does not disclose how such
reference profiles are created. See Braun 3:29-36; Ans. 13. The Examiner
finds that Hitt teaches a method for creating such a reference profile. Ans.
13 ( citing Hitt ,r 18). We sustain the rejection of claims 65 and 66 as
unpatentable over Braun, Fletcher, and Hitt.
Claim 67:
The Examiner found that Braun discloses compiling condition history
for particular patients by analyzing samples and storing test results over
extended periods of time in order to detect conditions based on a patient's
specific data history, and determined it would have been obvious to store the
test results in the database "with at least the identity of the entity in order to
associate results with the correct patient, thereby increasing the accuracy of
the determination of progression/regression of the entity's condition,
efficacy of the entity's treatment, etc." Final Act. 18 (citing Braun 7:24--51).
Appellants argue that "Braun's disclosure is specific to a single individual,
the patient," and, thus, storing the individual's identity would not improve
results or increase accuracy, but, rather, would be used "just to make sure
the proper comparison is made." Appeal Br. 24.
Appellants' arguments are unavailing. As Appellants admit, storing
the patient's identity with the test results in Braun's method would ensure
the proper comparison is made later. Although Braun may not specifically
discuss storing the results of more than one patient in a single database or on
a single computer, persons of ordinary skill in the art would have readily
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appreciated that medical providers and facilities typically do not limit their
services to a single patient and would have readily envisaged storing the test
results of multiple patients in a database for later comparison of current test
results of a particular patient to historical test results stored in the database.
Storing the test result data with at least the identity of patient associated with
the test results would help ensure a comparison is made to the correct test
results in the database, thereby increasing accuracy in assessing a patient's
condition and/or efficacy in treatment.
For the above reasons, Appellants do not apprise us of error in the
rejection of claim 67 as unpatentable over Braun, Fletcher, and Hitt, which
we, thus, sustain.
Claim 68:
Appellants argue that Hitt does not suggest "creating reference sets
based on [ A ]ppellants' data or one of [ A ]ppellants' identified
characteristics," and "[t ]here is no indication that Hitt is interested in
whether the markers are affected by any specific characteristic of an
individual." Appeal Br. 25. The Examiner points out, correctly, that claim
68 requires only that at least one of steps ( 1}-(10) be performed, and not all
of steps ( 1}-(10) require reference entities that share basic characteristics.
Ans. 14; see Appeal Br. 38-39 (Claims App.) (claim 68 reciting "[t]he
method of claim 61 further comprising at least one of" steps (1}-(10)
( emphasis added)). Thus, claim 68 may be satisfied without a reference
entity or population sharing basic characteristics. Moreover, the Examiner
cites disclosure in Hitt of reference populations that share a relevant
characteristic, such as a shared confirmed diagnosis/condition. Ans. 14
( citing Hitt ,r,r 64, 70).
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For the above reasons, Appellants do not apprise us of error in the
rejection of claim 68 as unpatentable over Braun, Fletcher, and Hitt, which
we, thus, sustain.
Claim 69:
The Examiner found that Braun teaches requesting the user to enter
information, such as diet information, which might affect the accuracy of the
obtained result, thereby indicating "the entity's diet may affect the results of
a performed analysis." Final Act. 20 (citing Braun 8:54---62). Thus, the
Examiner determined it would have been obvious to further modify Braun
by "providing a standard food diet for the test subjects in order to reduce
changes due to diet in the test result(s), thereby increasing the accuracy of
subsequent diagnosis therefrom." Id.
Appellants argue that "[t]here is no suggestion that there is need in
Braun's method for a consistent standard diet. The rejection changes the
mere notation of the diet into a 'standard' diet where the most that might be
inferred is that Braun may want a different reference for a different diet."
Appeal Br. 26.
As we pointed out in the Decision on the first appeal in the present
application,
[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.
Ex parte Haines, Appeal 2016-002832, 2017 WL 745106, at *12 (PTAB
Feb. 24, 2017); see also Ans. 15 (quoting from our Decision). Thus,
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Appellants do not apprise us of error in the rejection of claim 69 as
unpatentable over Braun, Fletcher, and Hitt, which we, thus, sustain.
Claim 70:
In contesting the rejection of claim 70, Appellants argue that none of
the applied references discloses the reference populations sharing one of the
characteristics recited in the claim. Appeal Br. 26. This argument is
unavailing because claim 70 only requires that the test results for the specific
living entity at a particular time be compared to a reference set of the same
kind of test results representative of the history of the specific living entity
itself or one or more reference populations sharing the same health condition
and basic characteristics of the specific living entity. Id. at 39--40 (Claims
App.). The Examiner's rejection is predicated on a finding that Braun
discloses the first alternative recited in claim 70, namely, comparison to test
results representative of the history of the entity itself. See Final Act. 20-21
(citing Braun 8:22-35); Ans. 16.
Appellants fail to apprise us of error in the rejection of claim 70 as
unpatentable over Braun, Fletcher, and Hitt, which we, thus, sustain.
Claim 71:
Appellants argue that any data mining software in Hitt "does not use
the data from the analytical method, but rather the compounds and/or
amounts of compounds identified by the analytical method." Appeal Br. 27.
This argument essentially reiterates a similar argument asserted against the
rejection of claim 61, which, for the reasons discussed above, is not
persuasive.
Appellants do not apprise us of error in the rejection of claim 71 as
unpatentable over Braun, Fletcher, and Hitt, which we, thus, sustain.
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Claim 72:
In rejecting claim 72, the Examiner found that Braun does not
expressly teach the entity being an animal other than a human, but Fletcher
teaches that the disclosed analytical methods are applicable to both humans
and non-human animals. Final Act. 22 (citing Fletcher 2:8-13). The
Examiner determined it would have been obvious to modify Braun's method
by applying it to an animal other than a human "in order to provide an
accurate, timely, and painless indicator of the health of said animal." Id.
(citing Braun 1:25--40; Fletcher 2:8-13).
Appellants assert that the Fletcher only mentions animals in the
background section and "[t]here is no follow up in the remainder of the
disclosure that indicates that the invention of Fletcher actually has any
relevance to animals." Appeal Br. 27. This argument is unpersuasive. A
person having ordinary skill in the art would have readily understood from
Fletcher's identification of "a 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" that the disclosed methods would be applicable to
both humans and non-human animals. See Fletcher 2:8-12.
Appellants do not apprise us of error in the rejection of claim 72 as
unpatentable over Braun, Fletcher, and Hitt, which we, thus, sustain.
Claim 74:
In contesting the rejection of claim 74, Appellants assert that Braun's
method "as modified does not provide [ A ]ppellants' speed and without the
speed it is very unlikely that anyone would use Braun for public health
reasons." Appeal Br. 28. This argument is not persuasive. As the Examiner
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points out, Fletcher teaches that "the method lends itself to massive
screening for disease." Ans. 18; see Fletcher 2: 12-13. Further, Hitt teaches
data mining techniques performed on a mass spectrum data stream that
reduce the time required. See Hitt ,r,r 13-14; Ans. 18. Appellants'
arguments that the method of the combination proposed in the rejection
lacks the speed of Appellants' method and would be unlikely to be used by
those of ordinary skill in the art for massive screenings for disease amounts
to unsupported attorney argument and, thus, is entitled to little, if any,
weight. See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997).
For the above reasons, Appellants do not apprise us of error in the
rejection of claim 74 as unpatentable over Braun, Fletcher, and Hitt, which
we, thus, sustain.
Claim 75:
Claim 75, like claim 72, recites that the "subject living entity is an
animal other than a human." Appeal Br. 40-41 (Claims App.). The findings
and reasoning of the Examiner, and the arguments thereagainst, essentially
mirror those discussed above in regard to claim 72. See id. at 29; Final Act.
23. Appellants' arguments are unpersuasive for the reasons discussed
above. Appellants also argue, in essence, that the rejection is too complex.
Appeal Br. 29. This vague statement fails to identify error in the rejection.
For the above reasons, Appellants do not apprise us of error in the
rejection of claim 75 as unpatentable over Braun, Fletcher, and Hitt, which
we, thus, sustain.
Claims 78 and 79:
Appellants' arguments in contesting the rejections of claims 78 and 79
essentially reiterate arguments discussed above. See Appeal Br. 31-32. For
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the reasons discussed above, Appellants' arguments also fail to apprise us of
error in the rejections of claims 78 and 79 as unpatentable over Braun,
Fletcher, and Hitt, which we, thus, sustain.
Rejection IV-Obviousness: Braun, Fletcher, Hitt, and Butler
Claim 73 depends from claim 72, and further recites that "the animal
is confined in a box with ventilation and the air leaving the box is conveyed
to a collection point for volatile materials given off by the animal." Appeal
Br. 40 (Claims App.). The Examiner found that Braun's method, modified
as discussed above in regard to claim 72, still lacks a teaching of the animal,
from which headspace materials are collected and analyzed, being confined
in a box with ventilation air leaving the box being conveyed to a collection
point as recited in claim 73. Final Act. 28. The Examiner found that Butler
teaches a method for testing breath for studying animals, wherein the animal
studied is confined in a box with ventilation and air leaving the box is
conveyed to a collection point for volatiles given off by the animal. Id.
( citing Butler ,r,r 58, 198; Fig. 1; claim 21 ). The Examiner determined it
would have been obvious to further modify Braun's method by confining the
animal to be tested in a box with ventilation and conveying the air leaving
the box to a collection point as taught by Butler "in order to facilitate breath
collection from non-human animals for further analysis." Id.
In addition to incorporating the arguments presented against the
obviousness rejection of claim 72, Appellants argue that Butler does not
teach confining a single animal in a chamber for the purpose of being
diagnosed and asserts that "[ t ]he use of a chamber for a population of rats as
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test animals does not suggest any diagnostic use for samples taken from the
atmosphere around a single animal." Appeal Br. 33.
Appellants' argument does not apprise us of error in the rejection of
claim 73. As discussed above, Fletcher's teaching of the need for a method
for detecting diseases, determining progress of disease, and measuring
effectiveness of treatment in humans and animals would have suggested
applying the method of Braun, modified in view of Fletcher and Hitt, to non-
human animals. However, Fletcher does not provide any details as to how
volatile materials would be collected from such non-human animals. Butler
discloses a method for collecting volatile materials from breath given off by
animals, comprising confining the animals to a chamber and conveying
breath samples to a collection point outside the chamber, for diagnostic
purposes. See Butler ,r,r 1, 59---60; Fig. 1. Although Butler discloses
confining a plurality of rats, rather than a single non-human animal, in a
chamber and collecting volatile materials from the plurality of rats, one of
ordinary skill in the art would have readily appreciated that this sampling
technique would work suitably for collecting volatile materials from a non-
human animal in the method of Braun, as modified in view of Fletcher and
Hitt.
Appellants do not apprise us of error in the rejection of claim 73 as
unpatentable over Braun, Fletcher, Hitt, and Butler, which we, thus, sustain.
Rejection V----Obviousness: Braun, Fletcher, Hitt, and Appel
Claim 7 6 depends from claim 61, and further recites "using the
method of [ c ]laim 61 under controlled conditions at least over a period of
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time while the said living entity uses said food or medicine." Appeal Br. 41
(Claims App.). Claim 77 depends from claim 76. Id.
The Examiner found that Braun, as modified, lacks a teaching of
using the method under controlled conditions over a period of time while the
living entity uses the diet, food, or medicine. Final Act. 29. The Examiner
found that Appel teaches evaluating the effect of a diet, food, or medicine on
a living entity under controlled conditions at least over a time period while
the living entity uses the food or medicine. Id. ( citing Appel 1117
(Abstract), 1118). The Examiner determined it would have been obvious to
further modify Braun by using the method under controlled conditions while
the living entity uses a diet, food, or medicine as taught by Appel "in order
to ensure/increase the likelihood that any changes in the patient's condition
are a result of the food or medicine being evaluated, thereby increasing the
accuracy of said evaluation." Id.
Appellants first incorporate the arguments attacking the combination
of Braun, Fletcher, and Hitt, which, for the reasons discussed above, do not
apprise us of error in the rejection of claim 61, and, likewise, fail to apprise
us of error in the rejection of claims 76 and 77. Appeal Br. 34. Appellants
then argue that there is no indication in any of the references of using the
diagnostic methods disclosed therein in studying the effects of diet,
medicine, etc. Id. Appellants' argument appears to insist upon an explicit
teaching, suggestion, or motivation in one or more of the prior art references
to make the modification. However, "[t]he obviousness analysis cannot be
confined by a formalistic conception of the words teaching, suggestion, and
motivation, or by overemphasis on the importance of published articles and
the explicit content of issued patents." KSR, 550 U.S. at 419. Instead, as
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discussed above, the relevant inquiry is whether the Examiner has set forth
"some articulated reasoning with some rational underpinning to support the
legal conclusion of obviousness." Kahn, 441 F.3d at 988, cited with
approval in KSR, 550 U.S. at 418. Further, as the Examiner points out,
Braun discloses utilizing the disclosed diagnostic method
to determine progression or regression of a medical condition
(col. 8, lines 22-36), and discloses diet control as a form of
treatment ( col. 7, lines 52-63). Appel teaches/suggests
monitoring the effect of a controlled diet on an individual's
medical condition (i.e., effects of diet on progression/regression
of a condition, such as hypertension). In light of these
teachings, it would have been obvious to one of ordinary skill
in the art to evaluate the effects of said treatment/controlled diet
by comparing changes in the individual's breath profile over the
time period in which said treatment/controlled diet is being
utilized in order to determine the effects of said
treatment/controlled diet on the progression or regression of the
individual's medical condition.
Ans. 19-20. Appellants' remarks on pages 34--36 do not identify any error
or deficiency in the findings or reasoning of the Examiner in this regard.
Thus, Appellants fail to apprise us of error in the rejection of claims 76 and
77 as unpatentable over Braun, Fletcher, Hitt, and Appel, which we, thus,
sustain.
DECISION
The Examiner's decision rejecting claims 61-79 under 35 U.S.C.
§ 112, second paragraph, is AFFIRMED as to claims 61-78, and
REVERSED as to claim 79.
The Examiner's decision rejecting claims 61-79 under
35 U.S.C. § 101 is AFFIRMED.
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The Examiner's decision rejecting claims 61-79 under
35 U.S.C. § 103(a) 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)(l )(iv).
AFFIRMED
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