Haines, Robyn Aylor. et al.

Patent Trials and Appeals Board

Dec 30, 2019

12925221 - (R) (P.T.A.B. Dec. 30, 2019)

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 12/30/2019
Robert B. Aylor
9502 Bluewing Terrace
Cincinnati, OH 45241
EXAMINER
WEARE, MEREDITH H
ART UNIT PAPER NUMBER
3791
MAIL DATE DELIVERY MODE
12/30/2019 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
Appeal 2019-000481
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 REQUEST FOR REHEARING
STATEMENT OF THE CASE
On August 13, 2019, Appellant1 filed a Request for Rehearing
(hereinafter “Request” or “Req. Reh’g) under 37 C.F.R. § 41.52 of the
Decision on Appeal (hereinafter “Decision” or “Dec.”) dated June 28, 2019.
In the Decision, the Board affirmed the Examiner’s rejection of claims
61–78 under 35 U.S.C. § 112, second paragraph, but reversed the rejection
of claim 79 under 35 U.S.C. § 112, second paragraph. The Board also
affirmed the Examiner’s rejections of claims 61–79 under 35 U.S.C. § 101

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a).
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as claiming patent-ineligible subject matter and under 35 U.S.C. § 103(a).
The Request seeks reconsideration of the Board’s Decision on the rejections
under 35 U.S.C. §§ 101 and 103(a). See Req. Reh’g 13 (requesting “reversal
of the rejections based upon unpatentable subject matter and the prior art”).
REQUIREMENTS FOR REQUEST FOR REHEARING
A Request for Rehearing must comply with the following
requirements:
The request for rehearing must state with particularity the
points believed to have been misapprehended or overlooked by
the Board. Arguments not raised, and Evidence not previously
relied upon, pursuant to §§ 41.37, 41.41, or 41.47 are not
permitted in the request for rehearing except as permitted by
paragraphs (a)(2) through (a)(4) of this section.
37 C.F.R. § 41.52(a)(1). Accordingly, apart from specific exceptions,
“[a]rguments not raised in the briefs before the Board and evidence not
previously relied upon in the brief and any reply brief(s) are not permitted in
the request for rehearing.” MPEP § 1214.03 (9th ed. rev. 08.2017
Jan. 2018); see also Cooper v. Goldfarb, 154 F.3d 1321, 1331 (Fed.
Cir. 1998) (“A party cannot wait until after the Board has rendered an
adverse decision and then present new arguments in a request for
reconsideration.”).
OPINION
Patent Eligibility
Appellant argues that the specificity of the steps recited in claim 61
“is clearly concrete,” in that the claimed method “is a solution for real life
problems involving aiding in the diagnosis of a patient’s condition.” Req.
Reh’g 4; see also id. at 10 (arguing that “[t]he method provides clear
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guidance leading to the identification of possible problems” and “is clearly a
very practical application”). Thus, according to Appellant, the recited steps
“cannot be characterized as an ‘abstract idea.’” Id. at 4. The fact that a
claimed method might aid in diagnosing a patient’s condition is not enough,
by itself, to render the claimed invention patent eligible. See, e.g., Ariosa
Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379–80 (Fed. Cir.
2015) (holding that, even where a claimed method “may have been a
significant contribution to the medical field, that alone does not make it
patentable”).
Following the USPTO’s 2019 Revised Patent Subject Matter
Eligibility Guidance, 84 Fed. Reg. 50 (January 7, 2019) (“2019 Eligibility
Guidance”), the Board’s Decision explains that claim 61 recites mental
processes (i.e., “comparing one thing (headspace-mass spectrometry data
from the subject living entity) to another thing (reference headspace-mass
spectrometry data),” and making a determination based on the comparison),
which fall within one of the groupings of abstract ideas. Dec. 13–15; see In
re BRCA1 & 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”). The Board, following the 2019 Eligibility Guidance,
further determined 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,” and, thus, “claim 61 is ‘directed to’ an abstract
idea.” See Dec. 16–21. With respect to Appellant’s query on page 10 of the
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Request as to what is meant by “practical application,” the 2019 Eligibility
Guidance provides discussion, including “exemplary considerations that an
additional element (or combination of elements) may have integrated the
exception into a practical application,” to explain what it means. See 2019
Eligibility Guidance, 84 Fed. Reg. at 55. Finally, following the 2019
Eligibility Guidance, the Board found “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.” See Dec. 21–23.
Appellant argues that “[l]ooking for patterns within results is not a
comparison,” but, rather, “involves discarding most of the test results and
only looking for patterns found within the results in both the patient’s test
and one or more comparative test data bases.” Req. Reh’g 12. Appellant’s
argument is not persuasive. Claim 61 positively recites a step of “comparing
said test results from said subject living entity at a particular time to at least
one of” similar reference test results from the subject living entity at a time
when the subject living entity’s condition was known and similar reference
test results “from at least one reference individual entity or reference
population of individual living entities.” Appeal Br. 37 (Claims App.)
(emphasis added). This clearly requires comparing one or more attributes of
the test data with the reference test results. Further, the argument’s focus on
patterns is not commensurate with the scope of claim 61, which does not
explicitly require looking for patterns in the claimed option “a” and only
requires that the comparison be accomplished “to determine at least one of”
“a.” and “b.” Thus, claim 61 covers embodiments that do not require
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looking for patterns. Nevertheless, even assuming that claim 61 requires
looking for patterns, and that looking for such patterns “involves discarding
most of the test results and only looking for patterns found within both the
patient’s test results and one or more reference test results,” as Appellant
contends, it is not apparent how that would integrate the judicial exception
(mental processes) into a practical application or provide an “inventive
concept” or add “significantly more” to transform the abstract concept into a
patent-eligible application. Alice, 573 U.S. at 217–18; see Content
Extraction and Transmission LLC v. Wells Fargo Bank, Nat. Ass'n, 776 F.3d
1343, 1347 (Fed. Cir. 2014) (holding ineligible claims “drawn to the abstract
idea of 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.”).
Appellant takes issue with the Board’s statement, on page 16 of the
Decision, that “the Examiner also correctly determined that claim 61 recites
a law of nature, which is also a judicial exception.” Req. Reh’g 4. In
particular, Appellant asserts that “[t]here is no inevitability about the
relationship between the volatile materials and the condition of the patient
that is sufficient to reach the level of a ‘law of nature.’” Id. (emphasis
added). Appellant’s assertion does not identify any point that the Board
misapprehended or overlooked, or otherwise show error in the Board’s
Decision, because the Board did not find that there was an inevitable
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relationship between the volatile materials and the condition of the patient.
Rather, the Board stated:
[T]he 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.
Dec. 16; see id. at 15 (citing Spec. 10:8-15 in support of this statement). As
the Board stated, “[t]his 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.” Id. at 15 (citing Mayo Collaborative
Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 77 (2012)).
Appellant contends that “[t]here has been no response or comment on
Evidence Appendix B” of the Appeal Brief, which, according to Appellant,
cites a reference that states there is no “relationship between the volatile
compounds found in a headspace sample taken from around a patient and the
condition of the patient.” Req. Reh’g 5. This contention and the subsequent
discussion on pages 5–7 of the Request are nothing more than an attempt to
rehash the arguments presented on pages 12–13, 18, and 25 of the Appeal
Brief and page 7 of the Reply Brief, which the Board considered and found
unpersuasive. See Dec. 16.2 Nothing in Exhibit B or in Hitt in any way
refutes that the relationship between the patterns in the headspace-mass

2 The Decision inadvertently referred to page 20 of the Appeal Brief instead
of page 18 of the Appeal Brief. See Dec. 16.
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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, as the Board stated in
the Decision.
Appellant argues that “[t]he assertion that an individual could practice
the claimed invention is clearly illogical.” Req. Reh’g 8. Appellant asserts
that “[t]he data sets herein are large enough to qualify as ‘big data’ requiring
a super computer” and that a single human being would not be able to
analyze this amount of data within an individual’s lifetime. Id. According
to Appellant, “[a] human brain is not able to handle this much data.” Id. To
the extent that this line of argument attempts to refute the Board’s
determination that claim 61 recites mental processes in the comparing step,
it is unpersuasive, for the reasons that follow. See id. at 11 (asserting, “The
statement that the comparing step is a mental process is also clearly
incorrect. A human could not make the comparison.”).
As pointed out above, as well as in the Decision, our reviewing court
has held that the concept of comparing one set of data to another to identify
similarities or differences between them is an abstract mental process. See,
e.g., In re BRCA1 & BRCA2-Based Hereditary Cancer Test Pat. Litig., 774
F.3d at 763 (concluding that the concept of “comparing BRCA sequences
and determining the existence of alterations” is an “abstract mental
process”).
Moreover, Appellant’s argument is not commensurate with the scope
of claim 61, which does not specify the size or amount of data, and does not
recite specific details with respect to the patterns to be compared or the
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manner of, or algorithm for, performing such a comparison. Appellant’s
Specification discloses using “multivariate analytical techniques to quickly
diagnose many different changes in living entities” by analyzing volatile
materials from other samples “to create reference sets comprising a large
amount of data” and comparing this data to reference data sets of similar
data. Spec. 6:8–12. The Specification states that “[t]his large amount of
data would normally overwhelm the health care provider or researcher,” and
that “[t]he method works best when the data is in digital form so that
computers can be used to compare and analyze the data.” Spec. 6:12–17
(emphasis added). In other words, the Specification expresses a preference
for using computers to analyze the data, and contemplates creating data sets
comprising an amount of data that would be overwhelming for a health care
provider or researcher, but claim 61 does not specify either the extent to
which the data is analyzed and compared or the size or number of data sets.
Thus, claim 61 is not necessarily limited to methods involving the “large
amount of data” that the Specification indicates would overwhelm
individuals. Further, the description of the method as working best when
computers are used to compare and analyze the data suggests that the
method would work, albeit perhaps not as well or as quickly, without
computers. See also id. at 18:29–31, 22:13–14, 25:25–26 (touting that the
method can be performed in a matter of minutes). Appellant’s Specification,
therefore, does not support Appellant’s assertion that a human being could
not perform the claimed comparing step mentally or with pen and paper, nor
does Appellant provide any persuasive objective evidence that this would be
the case.
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Moreover, even accepting Appellant’s premise that a human being
could not perform the task disclosed in the present application by taking the
data and comparing it to reference data sets mentally, this would not be
dispositive of patent eligibility because “the inability for the human mind to
perform each claim step does not alone confer patentability.” FairWarning
IP, LLC v. Iatric Sys. Inc., 839 F.3d 1089, 1098 (Fed. Cir. 2016). As our
reviewing court has explained, “the fact that the required calculations could
be performed more efficiently via a computer does not materially alter the
patent eligibility of the claimed subject matter.” Bancorp Servs., L.L.C. v.
Sun Life Assur. Co. of Can. (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012).
Thus, the fact that the comparison of the test data to the reference data sets
could be performed more quickly or efficiently via a computer does not
materially alter the patent eligibility of Appellant’s claims.
Appellant argues that “the invention is not based solely on a
‘comparing step’. There can be no comparing step without the proper data
bases and without the proper software.” Req. Reh’g 11. Appellant submits
that “[o]nly ‘pattern mining software’ and large computers can be used for
large data sets like the ones created in the claimed method.” Id. The Board
did not overlook or ignore this limitation. See Dec. 19 (pointing out that
claim 61 recites the data mining software generically). As the Examiner
pointed out, although claim 61 recites that the comparing step “is
accomplished by a computer and data mining software, the step is not
limited to any particular type of data mining algorithm; there is no limit
placed on what types of ‘conditions’ the reference individuals or populations
are known to have; etc.” Final Act. 9 (italics omitted). Thus, the data
mining software limitation, considered individually and in combination with
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the other elements of claim 61, does not apply, rely on, or use 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 so as to integrate claim 61 into a
practical application. See Dec. 16–17, 21.
Appellant’s arguments, therefore, do not apprise us of error in the
Board’s determination that “claim 16 is ‘directed to’ an abstract idea.” See
Dec. 21.
Appellant cites some principles set forth in Vanda Pharms. Inc. v.
West-Ward Pharms. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018), but does not
cogently explain how they relate to the present claims, which do not recite a
treatment method that practically applies natural relationships. See October
2019 Update: Subject Matter Eligibility, (available at https://www.uspto.gov
/sites/default/files/documents/peg_oct_2019_update.pdf), 13–14 (Oct. 17,
2019) (“The 2019 [Eligibility Guidance] includes a ‘treatment/prophylaxis’
consideration, under which a claim can integrate a judicial exception into a
practical application by applying or using the judicial exception to effect a
particular treatment or prophylaxis for a disease or medical condition. . . .”).
Moreover, the claims do not apply a specific compound at specific doses to
treat a particular medical condition for specific patients in a manner
analogous to the eligible treatment method in Vanda. See Vanda, 887 F.3d
at 1136 (“At bottom, the claims here are directed to a specific method of
treatment for specific patients using a specific compound at specific doses to
achieve a specific outcome.”). In contrast, claim 61, considered as a whole,
is directed to comparing collected test data to reference data sets to
determine either whether there are differences between them or whether
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there are similarities between them. As indicated in the preamble of claim
61, the method can be used to facilitate determining the condition of a
subject living entity at a particular time, but claim 61 does not recite any
steps of treating any determined condition. See Appeal Br. 37 (Claims
App.). To the extent that the Vanda principles cited by Appellant are
applicable generally to all claims, not just to methods of treating a medical
condition, Appellant does not state with particularity how the Board
misapprehended or overlooked these principles in the Decision.
For the above reasons, Appellant does not persuade us that the Board
erred in sustaining the rejection of claims 61–79 under 35 U.S.C. § 101.
Obviousness
Appellant acknowledges that “headspace mass spectrometry generates
[Appellant’s] claimed data,” but contends that the applied prior art,
particularly Fletcher, does not save the mass spectral channel signals, much
less use them to form any data base. Req. Reh’g 1. Rather, Appellant
submits that, in the prior art, this “data exists for only so long as it takes to
convert it into the identity of the compounds and their amounts in the
headspace sample.” Id. This line of argument merely rehashes the
arguments set forth on pages 17–21 of the Appeal Brief, which the Board
addressed on pages 25–28 of the Decision.
Appellant submits that
Braun’s disclosure is directed solely to Braun’s preferred
method in which the absorption of wavelengths of light are
measured using a sample containing compounds that are initially
collected from around a patient, the absorption results being
plotted in a line graph and compared with standard line graphs
representing know[n] conditions.
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Req. Reh’g 8–9. Appellant asserts that “Braun clearly teaches that his
analytical method is preferred as compared to all other methods” and that
“[t]his amounts to a ‘teaching away.’” Id. at 9. The Board addressed this
point on pages 26–27 of the Decision. See Dec. 27 (stating, “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.” (citing Ans. 10)). A
reference does not teach away if it merely expresses a general preference for
an alternative invention from amongst options available to the ordinarily
skilled artisan, and the reference does not discredit or discourage
investigation into the invention claimed. See In re Fulton, 391 F.3d 1195,
1201 (Fed. Cir. 2004) (“mere disclosure of alternative designs does not teach
away”). We are further guided by instructions from our reviewing court that
“[w]e will not read into a reference a teaching away from a process where no
such language exists.” DyStar Textilfarben GmbH & Co. Deutschland KG
v. C.H. Patrick Co., 464 F.3d 1356, 1364 (Fed. Cir. 2006).
Appellant argues that Fletcher does not teach Appellant’s “claimed
data sets” (i.e., “test results that are the mass spectral channel signals (m/z)
after electron-ionization of the said volatile material in said headspace
material” (Appeal Br. 37 (Claims App.))) because “[n]either the term ‘mass
spectral channel signals (m/z)’ or any equivalent appears anywhere in
Fletcher or in any other cited art.” Req. Reh’g 9. This argument is not
persuasive. As the Board stated:
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
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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 provide test results.” Id. at 13–14 (citing
Fletcher 4:58–5:3; 8:20–37).
Dec. 24–25 (citing Final Act. 13–14). Further, as the Board emphasized in
the Decision, the Examiner pointed out, and Appellant did 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.” Dec. 27 (citing Ans. 11). In fact, as mentioned above, Appellant
expressly states, “Of course headspace mass spectrometry generates
[Appellant’s] claimed data.” Req. Reh’g. 1.
The remaining points regarding Fletcher made on page 9 of the
Request attack Fletcher individually, rather than the combination, and, thus,
do not apprise of error in either the Examiner’s obviousness rejections or the
Board’s decision to sustain these rejections. Nonobviousness cannot be
established by attacking the references individually when the rejection is
predicated upon a 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)).
Appellant submits that the “[t]he claimed method is a practical way to
assist a physician in making a determination of what may be wrong with a
simple single test that takes only minutes to run” and asserts that “[t]he
rejections ignore the clear limits of the claims.” Req. Reh’g 2. Appellant’s
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vague statement regarding “the clear limits of the claims” fails to state with
particularity any point believed to have been misapprehended or overlooked
by the Board.
For the above reasons, Appellant’s Request does not persuade us that
the Board erred in sustaining the obviousness rejections.
CONCLUSION
Appellant’s Request has been granted to the extent that we have
reconsidered our Decision in light of the arguments in Appellant’s Request,
but is denied with respect to our making any modification to the Decision.
Outcome of Decision on Rehearing:
Claims 35 U.S.C § Reference(s)/Basis Denied Granted
61–79 101 Eligibility 61–79
61–72, 74,
75, 78, 79
103(a) Braun, Fletcher,
Hitt
61–72, 74,
75, 78, 79

73 103(a) Braun, Fletcher,
Hitt, Butler
73
76, 77 103(a) Braun, Fletcher,
Hitt, Appel
76, 77
Overall
Outcome
61–79

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Final Outcome of Appeal after Rehearing:
Claims 35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
61–79 112,
second
paragraph
Indefiniteness 61–78 79
61–79 101 Eligibility 61–79
61–72, 74,
75, 78, 79
103(a) Braun, Fletcher,
Hitt
61–72, 74,
75, 78, 79

73 103(a) Braun, Fletcher,
Hitt, Butler
73
76, 77 103(a) Braun, Fletcher,
Hitt, Appel
76, 77
Overall
Outcome
61–79

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).
DENIED