Robyn Haines et al.

Patent Trials and Appeals Board

Mar 31, 2021

2020006456 (P.T.A.B. Mar. 31, 2021)

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 03/31/2021
Robert B. Aylor
9502 Bluewing Terrace
Cincinnati, OH 45241
EXAMINER
WEARE, MEREDITH H
ART UNIT PAPER NUMBER
3791
MAIL DATE DELIVERY MODE
03/31/2021 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 2020-006456
Application 12/925,221
Technology Center 3700
Before MICHAEL L. HOELTER, BRETT C. MARTIN, and
CARL M. DEFRANCO, Administrative Patent Judges.
MARTIN, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 96–111. See Final Act. 1. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as Robyn A. Haines and
Robert B. Aylor. Appeal Br. 1.
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CLAIMED SUBJECT MATTER
The claims are directed to a diagnostic testing. Claims 96 and 106,
reproduced below, are illustrative of the claimed subject matter:
96. A digital health record for a living entity comprising the
results obtained by collecting at least one sample of volatile
headspace material given off from said living entity at a specific
time; electron-ionization of said volatile headspace material
using a head space-mass spectrometer to obtain mass spectral
channel signals (m/z); and storing said mass spectral channel
signals to create said digital health record.

106. A method of determining whether the health of an
individual living entity has changed wherein the digital health
record of said individual entity at a time in the past as in Claim
96 is compared with the digital health record of the same
individual entity as in Claim 96 at the present time using pattern
recognition software to determine if there has been a change.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Fletcher US 4,003,257 Jan. 18, 1977
Braun US 7,101,340 B1 Sep. 5, 2006
Agus US 2004/0096896 A1 May 20, 2004
Cotter US 2008/0258054 A1 Oct. 23, 2008
Al US 2011/0105339 A1 May 5, 2011

REJECTIONS
Claims 106–111 are rejected under 35 U.S.C. § 112(b) or pre-AIA
35 U.S.C. § 112, second paragraph, as being indefinite for failing to
particularly point out and distinctly claim the subject matter which the
inventor or a joint inventor, or for pre-AIA the applicant regards as the
invention. Final Act. 2.
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Claims 96–111 stand rejected under 35 U.S.C. § 101 as directed to
non-statutory subject matter. Final Act. 3.
Claims 96–105 and 108–111 stand rejected under pre-AIA 35 U.S.C.
§ 103(a) as unpatentable over Agus and Fletcher. Final Act. 9.
Claims 96–98, 100, and 106–108 stand rejected under pre-AIA 35
U.S.C. § 103(a) as unpatentable over Braun, Fletcher, and Cotter. Final Act.
14.
Claims 96–105 and 108–111 stand rejected under pre-AIA 35 U.S.C.
§ 103(a) as unpatentable over Braun, Fletcher, and Agus. Final Act. 16.
OPINION
Patent Eligibility
In issues involving subject matter eligibility, our inquiry focuses on
whether the claims satisfy the two-step test set forth by the Supreme Court in
Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014). The Supreme Court
instructs us to “first determine whether the claims at issue are directed to a
patent-ineligible concept,” id. at 216–18, and, in this case, the inquiry
centers on whether the claims are directed to an abstract idea. If this initial
condition is met, we then move to the second step, in which we “consider
the elements of each claim both individually and ‘as an ordered
combination’ to determine whether the additional elements ‘transform the
nature of the claim’ into a patent-eligible application.” Id. at 217 (quoting
Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 79, 78
(2012)). The Supreme Court describes the second step 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
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than a patent upon the [ineligible concept] itself.’” Id. (quoting Mayo, 566
U.S. at 72–73).
The USPTO published revised guidance on the application of § 101.
2019 Revised Patent Subject Matter Eligibility Guidance (“Guidance”), 84
Fed. Reg. 50 (Jan. 7, 2019).2 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
human activity such as a fundamental economic practice, and
mental processes) (“Step 2A, Prong One”); and
(2) additional elements that integrate the judicial exception into a
practical application (see MPEP § 2106.05(a)–(c), (e)–(h) (9th ed.
Rev. 08.2017, Jan. 2018)) (“Step 2A, Prong Two”).
Only if a claim (1) recites a judicial exception and (2) does not integrate that
exception into a practical application, do we then look, under “Step 2B,” to
whether the claim:
(3) adds a specific limitation beyond the judicial exception that is 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.

2 In response to received public comments, the Office issued further
guidance on October 17, 2019, clarifying the 2019 Revised Guidance.
USPTO, October 2019 Update: Subject Matter Eligibility,
https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_
update.pdf.
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See generally Guidance.
Our reviewing court has warned that “the Office Guidance is not,
itself, the law of patent eligibility” and “does not carry the force of law.” In
re Rudy, 956 F.3d 1379, 1382 (Fed. Cir. 2020); see also cxLoyalty, Inc. v.
Maritz Holdings Inc., No. 2021-1307, 2021 WL 416719, *6 n.1 (Fed. Cir.
Feb. 8, 2021); Cleveland Clinic Found. v. True Health Diagnostics LLC, 760
F. App’x 1013, 1020 (Fed. Cir. 2019). Rather, “it is our [reviewing court’s]
caselaw, and the Supreme Court precedent it is based upon, that must
control.” Rudy, 956 F.3d at 1383 (citation omitted). Thus, although our
analysis may be framed in terms of the 2019 Revised Guidance, our decision
is based upon governing precedent of the United States Supreme Court and
our reviewing court’s interpretation and application thereof.
ANALYSIS
Claim Grouping
Appellant argues the claims as a group for the purpose of the rejection
under a judicial exception to § 101. Appeal Br. 6–15. As to this rejection,
we select claims 96 and 106 as representative of the group, and the
remaining claims stand or fall with these claims. See 37 C.F.R.
§ 41.37(c)(1)(iv).
Examiner’s Findings and Conclusion
In the first step of the Alice inquiry, the Examiner first rejects claims
96 as not directed to statutory subject matter. Final Act. 3. Regarding
claims 106, the Examiner finds that these claims are directed to a judicial
exception without significantly more, namely mental processes. Final Act.
4. At Alice step 2, the Examiner additionally finds that the claims do not add
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a meaningful limitation to the abstract idea so as to amount to significantly
more than the judicial exception. Id.
Analysis According to the Guidance
Step One: Do Claims 96 and 106 Fall within a Statutory Category of
§ 101?
We first examine whether the claim recites one of the enumerated
statutory classes of subject matter, i.e., process, machine, manufacture, or
composition of matter, eligible for patenting under 35 U.S.C. § 101. Claim
96 is directed to nothing more than a record, which as the Examiner notes is
nothing more than data. Data is not one of the statutory classes and as such,
the claims are not patent eligible. Claim 106 is directed to a method, which
is one of the statutory classes (i.e., a process) under 35 U.S.C. § 101.
Step 2A, Prong One: Does Claim 106 Recite a Judicial Exception?
We next look to whether the claim recites any judicial exceptions,
including certain groupings of abstract ideas, i.e., mathematical concepts,
certain methods of organizing human activity such as a fundamental
economic practice, and mental processes.
In this instance, claim 106 recites steps that amount to mental
processes. Specifically, the claim recites: “determining whether the health
of an individual living entity has changed,” comparing a past digital health
record to a present health record, “using pattern recognition software to
determine if there has been a change.”
Although these steps are claimed as being done by a computer, the
activities themselves are all capable of being performed by a human without
a computer, and fall into the abstract idea of mental processes. See, e.g.,
CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1375 (Fed. Cir.
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2011) (“That purely mental processes can be unpatentable, even when
performed by a computer, was precisely the holding of the Supreme Court in
Gottschalk v. Benson.”). We therefore determine that claim 106 recites the
abstract idea of mental processes, which is a judicial exception to patent-
eligible subject matter.
Step 2A, Prong Two: Does Claim 106 Recite Additional Elements that
Integrate the Judicial Exception into a Practical Application?
Following our Office guidance, having found that claim 106 recites a
judicial exception, we next determine whether the claim recites “additional
elements that integrate the exception into a practical application” (see MPEP
§§ 2106.05(a)–(c), (e)–(h)). See Guidance, 84 Fed. Reg. at 54. As noted
above, each of the claimed steps is recited as being performed by a computer
or storage device specified at a high level of generality and, does not result
in an improvement in the functioning of a computer or other technology or
technological field. The recitations of the generic structures with which the
recited steps are performed are merely instructions to use a generic computer
system as a tool to perform the abstract idea. Thus, claim 106 does not
apply, rely on, or use the mental process steps in a manner that imposes a
meaningful limit on those steps. Rather, the claim is simply a drafting effort
designed to monopolize the mental process steps of claim 106. See MPEP
§ 2106.05(f) (“Use of a computer or other machinery in its ordinary capacity
for . . . tasks (e.g., to receive, store, or transmit data) or simply adding a
general purpose computer or computer components after the fact to an
abstract idea . . . does not . . . provide significantly more.”).
In short, the additional elements discussed above: (1) do not result in
an improvement to the functioning of a computer or other technology; (2)
are not any particular machine; (3) do not effect a transformation of a
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particular article to a different state; and (4) are not applied in any
meaningful way beyond generally linking the use of the judicial exception to
a particular technological environment. See MPEP §§ 2106.05(a)–(c),
(e)–(h). Consequently, the claimed invention does not integrate the abstract
idea into a “practical application.”
For these reasons, the additional elements of claim 106 do not
integrate the judicial exception into a practical application. Thus, claim 106
is directed to an abstract idea, which is a judicial exception to patent-eligible
subject matter under 35 U.S.C. § 101.
Step 2B: Does Claim 106 Recite an Inventive Concept?
We next consider whether claim 106 recites any additional elements,
individually or as an ordered combination, that transform the abstract idea
into a patent-eligible application, e.g., provide an inventive concept. Alice,
573 U.S. at 217–18. The only additional elements are a computer, a
database, and pattern recognition software. Ans. 3. These additional
elements do not provide, either individually or as a combination,
improvements to another technology or technical field or the functioning of
the computer itself, but merely are conventional computing components
included to perform the method.
According to Office guidance, under Step 2B, “examiners should . . .
evaluate the additional elements individually and in combination . . . to
determine whether they provide an inventive concept (i.e., whether the
additional elements amount to significantly more than the exception itself).”
See Guidance, 84 Fed. Reg. at 56 (emphasis added). Thus, the second step
of the inquiry (Step 2B) looks at the additional elements in combination.
See BSG Tech LLC v. BuySeasons, Inc., 899 F.3d 1281, 1290 (Fed. Cir.
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2018) (“It has been clear since Alice that a claimed invention’s use of the
ineligible concept to which it is directed cannot supply the inventive concept
that renders the invention ‘significantly more’ than that ineligible concept.”).
As noted above, the storage device, computer, database, and software
are invoked as conventional tools. Apart from being used to perform the
abstract idea itself, the generic computer system components only serve to
perform well-understood functions (e.g., retrieving, determining, presenting,
providing, etc.). See FairWarning IP, LLC v. Iatric Sys., Inc., 839 F.3d
1089, 1096 (Fed. Cir. 2016) (“[T]he use of generic computer elements like a
microprocessor or user interface do not alone transform an otherwise
abstract idea into patent-eligible subject matter.”). In our view, claim 106
fails to add a specific limitation beyond the judicial exception that is not
“well-understood, routine, conventional” in the field, but 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 Guidance, 84 Fed. Reg. at 56. That is, claim 106 is not
directed to a specific application designed to achieve an improved
technological result, as opposed to being directed to merely ordinary
functionality of the above-recited additional elements to apply an abstract
idea. For the reasons discussed above, we find no additional element, alone
or in combination, recited in claim 106 that contains any “inventive concept”
or adds anything “significantly more” to transform the abstract concept into
a patent-eligible application. See Alice, 573 U.S. at 221.
Appellant’s Contentions
Regarding claim 96, Appellant asserts that “[t]he claims cannot be
read as covering data per se” because “[t]he data is tied to a patient or it is
not a health record.” Reply Br. 7. This argument does not rebut the
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Examiner’s findings, and, in fact, confirms that claim 96 is directed to a
health record, which is nothing more than a specific type of data. It does not
matter that the data at issue “have to be in a form that can be used for
computer comparisons” because all that means is that the data is in a
computer readable form. Id. The records are still nothing more than data,
which is not a statutory category of eligible subject matter.
As to claim 106, Appellant asserts that “no one could seriously
believe that any human mind is equipped to practically perform a
comparison of health records using pattern recognition software.” Reply Br.
10. This argument misunderstands the eligibility analysis. It does not
matter if the claim utilizes computers, programming, software, etc. to
perform what is otherwise a mental process. In this case, as identified by the
Examiner, the abstract idea in claim 106 is the comparing of records to
determine a difference between a past and a present record. A computer
may be used to speed up the process, but a comparison of two medical
records is something that may be done by the human mind. Again, it does
not matter that the health record is claimed as being digital because, first, a
digital record in and of itself is not patent eligible, and second a digital
record is just a digital representation of something that could also be printed
out onto paper as was done before computers. Similarly, a doctor having a
past record and a present record could review the paper records and do a
comparison to determine if any change had occurred. As such, the claims do
nothing more than perform on a computer what may otherwise be performed
in the human mind.
Obviousness
Regarding the § 1.131 declaration, the Examiner is correct that such a
declaration “is not appropriate for the Cotter reference,” because “Cotter was
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published more than a year before the effective filing date of the present
application.” Ans. 13. Appellant appears to misunderstand the availability
of a declaration to rebut obviousness. A § 1.131 declaration may only be
used to remove a reference from consideration if that reference is within a
year of the filing of the application. Because Cotter is more than a year prior
to Appellant’s filing date, it is ineffective as a tool to overcome Cotter.
As to Fletcher, the Examiner is correct that “[t]he output of a mass
spectrometer, by definition, is the mass-to-charge ratio (m/z) of ions
following [the] ionization of a sample.” Ans. 13. Accordingly, Appellant’s
argument that “[i]t is clear that Fletcher does not teach appellants’ mass
spectral channel signals (m/z)” is not persuasive.
Regarding the combination of Braun and Fletcher, Appellant argues
that the motivation to combine the references “ignores the simple fact that
Fletcher does not disclose any use of the mass spectral signals per se and
discloses only patterns based upon compounds that have no extraneous data
present.” Appeal Br. 16. This argument misunderstands the Examiner’s
rejection. According to the Examiner, Braun teaches the use of the medical
record that comprises saving a profile of compounds produced by a
spectrometer. Ans. 14. The Examiner admits that Braun does not explicitly
disclose the use of a mass spectrometer as the source of the record and
points to Fletcher as specifically disclosing that “a mass spectrometer is a
sensitive analyzer that can be used to produce a profile of a headspace
volatile material.” Id. Accordingly, the Examiner uses the teaching of the
use of the medical record in Braun with the specific disclosure of a record
containing data obtained from a mass spectrometer, which falls within the
general class of spectrometers described in Braun.
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As to Cotter, Appellant asserts that “[t]he Cotter samples are derived
from blood or plasma which are not volatile materials.” Appeal Br. 16–17.
The Examiner, however, states that Cotter is not used for the specific
“disclosure of using a volatile material or its sample preparation,” rather
Cotter is merely used for disclosing “the use of pattern recognition software
to perform a comparison(s) of a patient profile/mass spectrum to a reference
profile/mass spectrum.” Ans. 15. The Examiner is correct that Appellant
attacks Cotter as lacking something for which it was not used to teach.
The Examiner is also correct that “Appellant’s assertion that ‘there is
no need for using pattern recognition software [in Cotter],’ appears in direct
opposition to the disclosure of Cotter” in that Cotter teaches the use of a
pattern recognition system throughout its disclosure. Ans. 15. We also
agree with the Examiner that Cotter discloses a comparison to a known
antigen merely as an optional step. Ans. 16. As the Examiner states, Cotter
“further discloses the pattern recognition is performed directly on the mass
spectrum (i.e., signals from the mass spectrometer) to identify patterns
therein.” Id. (citing Cotter ¶ 30). Accordingly, Cotter adequately teaches
the use of pattern recognition software for the comparison as claimed. As
such, we are not persuaded of error in the Examiner’s rejection of claims
96–98, 100, and 106–108 as unpatentable over Braun, Fletcher, and Cotter.
Regarding Agus, as with Cotter above, a § 1.131 declaration is not
effective against a reference that is more than one year prior to Appellant’s
filing date. Additionally, as with the previous rejection, Appellant attacks
the Examiner’s use of Agus for aspects not alleged to be taught by Agus.
The Examiner is correct that “Agus expressly discloses saving mass spectral
signals (i.e., mass spectrum) as a health record along with other patient data
for subsequent pattern recognition and comparison to reference profiles.”
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Ans. 17 (citation omitted). As the Examiner states, “[t]he examiner does not
contend that Agus alone teaches/suggests collecting the headspace from said
materials, only that one of ordinary skill in the art would recognize at least
some of the body fluids disclosed by Agus are materials that emit VOCs.”
Id. It is Fletcher that is used to disclose “producing a record/profile for a
volatile headspace material using a mass spectrometer.” Id. Appellant’s
arguments attack the references for aspects they were not alleged to have
taught for the purpose of the rejection. Accordingly, we are not persuaded
of error in the Examiner’s rejection of claims 96–105 and 108–111 as being
obvious over Braun, Fletcher, and Agus.
Indefiniteness
The Examiner rejects claim 106 for failing to claim a positively
recited method step. Ans. 5. The Examiner is correct that claim 106 uses
passive voice, which is not a preferred manner of claiming a method step.
Although we urge Appellant to address this issue in any further prosecution,
we conclude that one of ordinary skill in the art would understand what is
meant and therefore do not sustain the rejection on this basis.
The Examiner is also correct that claim 106 lacks a clear transitional
phrase. We agree with the Examiner that “because of the numerous
‘wherein’ clauses and use of passive voice and/or past participles, the metes
and bounds of the claimed invention were unable to be determined.” Ans. 6.
Appellant states that there is no requirement of a transitional phrase, but we
note that the claims should include a preamble ending in “comprising,”
“consisting of,” or “consisting essentially of.” Such phrases signal to the
public whether the claim is open-ended (i.e., may contain more than the
claim), closed-ended (i.e., may contain only what is claimed), or closed-
ended but allowing for insignificant additional elements. Appellant appears
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to concede the indefiniteness by stating that he would be amenable to
changing the claims as recommended. See, e.g., Appeal Br. 8. Appellant
will be able to correct these drafting errors in any further prosecution.
Accordingly, we sustain the Examiner’s rejection regarding the lack of a
clear transitional phrase.
CONCLUSION
The Examiner’s rejections are AFFIRMED.
More specifically,
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
96–111 101 Eligibility 96–111
96–105,
108–111
103(a) Agus, Fletcher 96–105,
108–111

96–98, 100,
106–108
103(a) Braun, Fletcher,
Cotter
96–98, 100,
106–108

96–105,
108–111
103(a) Braun, Fletcher,
Agus
96–105,
108–111

106–111 112 Indefiniteness 106–111
Overall
Outcome
96–111

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED