Mark A. Hayes et al.

Patent Trials and Appeals Board

Apr 29, 2020

14474267 - (D) (P.T.A.B. Apr. 29, 2020)

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.
14/474,267 09/01/2014 Mark A. Hayes HT-002 9343
40654 7590 04/29/2020
JACK S. EMERY, P.A.
2081 NW Everett #101
Portland, OR 97209
EXAMINER
MAHATAN, CHANNING S
ART UNIT PAPER NUMBER
1636
NOTIFICATION DATE DELIVERY MODE
04/29/2020 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
jack@jacksemerypa.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

Ex parte MARK A. HAYES and THOMAS J. TAYLOR1
________________

Appeal 2019–000486
Application 14/474,267
Technology Center 1600
________________

Before: JEFFREY N. FREDMAN, JOHN G. NEW, and
JAMIE T. WISZ, Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION ON APPEAL

1 We use the word “Appellant” to refer to the “applicant” as defined in
37 C.F.R. § 1.142. Appellant identifies the inventors, Mark A. Hayes and
Thomas J. Taylor, as the real parties-in-interest. App. Br. 2.
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SUMMARY
Appellant files this Appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 1–20. Specifically, claims 1–3, 5, 6, 8,
9, 11, and 122 stand rejected as unpatentable under 35 U.S.C. §101 as being
directed to nonstatutory subject matter.
Claims 1–3, 5, 6, 8, 9, 11, and 13 stand rejected as unpatentable under
35 U.S.C. § 103(a) as being obvious over Ecker et al. (US 8,822,156 B2,
September 2, 2014) (“Ecker”) and Kasif et al (US 7,047,137 B1, May 16,
2006) (“Kasif”).
Claims 1–6, 8, 9, 11, and 13 stand rejected as unpatentable under 35
U.S.C. § 103(a) as being obvious over Ecker, Kasif, and R. Tellier, Review
of Aerosol Transmission of Influenza A Virus. 12(11) EMERGING INFECT.
DIS. 1657-1662 (2006) (“Tellier”).
Claims 1–3, 5–13, and 16–19 stand rejected as unpatentable under 35
U.S.C. § 103(a) as being obvious over Ecker, Kasif, and Chou et al. (US
2004/0072278 A1, April 15, 2004) (“Chou”).3
Claims 1–3, 5–13, and 16–20 stand rejected as unpatentable under 35
U.S.C. § 103(a) as being obvious over Ecker, Kasif, Chou, and GE

2 The rejection of claims 4, 7, and 10 on this ground were withdrawn by the
Examiner. See Ans. 20.

3 Claims 14 and 15 are not included by the Examiner in the claims rejected
upon this ground (see Final Act. 18), but are expressly included in the
Examiner’s subsequent analysis. Id. at 22. We therefore include claims 14
and 15 in our analysis of this rejection, as they were inadvertently omitted
from the statement of rejection.
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Healthcare, Label-free Interaction Analysis in Real-time Using Surface
Plasmon Resonance, TECHNOLOGY NOTE 23, 1–8 (2007) (“Biacore”).
Claims 1–3, 5–13, and 16–20 stand rejected as unpatentable under 35
U.S.C. § 103(a) as being obvious over Ecker, Kasif, Chou, and R.J. Whelan
et al., Surface Plasmon Resonance Detection for Capillary Electrophoresis
Separations, 75 ANAL. CHEM. 1542–47 (2003) (“Whelan”).
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.

NATURE OF THE CLAIMED INVENTION
Appellant’s claimed invention is directed to methods and apparatus
for identifying the source of bioparticles, such as bioparticles shed by an
organism. Abstr.

REPRESENTATIVE CLAIM
Independent claim 1 is representative of the claims on appeal
and recites:
1. A method for identifying a biological source, the method
comprising:

collecting from the environment a plurality of bioparticles
shed by a biological source organism;

selecting one or more information-rich bioparticles from
the plurality of bioparticles;

restricting the movement of the one or more information-
rich bioparticles;

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detecting a plurality of bioparticle signatures from the one
or more information-rich bioparticles;

processing the plurality of said bioparticle signatures into
a multi-dimensional vector by combining bioparticle
signatures; and

identifying the biological source based upon comparison
of said multi-dimensional vector to a standard multi-
dimensional vector using a pattern recognition strategy.

App. Br. 24. Independent claim 13 is directed to an apparatus, and
recites:
13. An apparatus for identifying a biological source organism
from bioparticles shed by the organism into the environment, the
apparatus comprising:

a particle collector configured to collect a sample
containing a plurality of bioparticles;

a selection and concentration system coupled to the
particle collector, configured to select one or more
information-rich bioparticles from the plurality of
bioparticles;

a bioparticle signature detector coupled to the selection
and concentration system, the bioparticle signature
detector comprising means for restricting the movement of
the information-rich bioparticles and means for detecting
a plurality of bioparticle signatures therefrom; and

a pattern recognition system linked to the bioparticle
signature detector and configured to derive a multi-
dimensional vector from the bioparticle signatures by
combining the bioparticle signatures and to compare said
multi-dimensional vector with a standard multi-
dimensional vector in order to identify, from the one or
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more information-rich bioparticles, the biological source
from which the bioparticles were shed.

Id. at 25.

ISSUES AND ANALYSES
We agree with and adopt, the Examiner’s findings, reasoning, and
conclusion that claims 1–3, 5, 6, 8, 9, 11, and 12 are directed to nonstatutory
subject matter, and that claims 1–4 and 7–12 are obvious over the combined
cited prior art. We decline to affirm the Examiner’s conclusion that claims
5, 6, and 13–20 are obvious over the combined cited prior art. We address
the arguments raised sequentially by Appellant below.

A. Rejection of the claims 1–3, 5, 6, 8, 9, 11, and 12 under 35 U.S.C.
§ 101

Issue
Appellant argues that the Examiner erred in concluding that the claims
ae directed to a patent-ineligible abstract idea. App. Br. 1–19.

Analysis
The Examiner finds that the claims are directed to a method for
identifying the biological source of bioparticles, comprising a combination
of “mental” and “physical” steps. Final Act. 3. The Examiner finds that the
steps reciting “processing the plurality of said bioparticle signatures into a
multi-dimensional vector by combining bioparticle signatures” and
“identifying the biological source based upon comparison of said
multidimensional vector to a standard multi-dimensional vector using a
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pattern recognition strategy” are “mental” steps evaluating and/or
interpreting data, by which detected bioparticle signatures are processed into
a multi-dimensional vector by some undefined methodology or algorithm,
and which is subsequently compared to a standard multi-dimensional vector,
also using an undefined pattern recognition strategy (i.e., an abstract idea).
Id. at 3–4.
The Examiner finds that the steps reciting: (1) “collecting”
bioparticles shed by a biological source; (2) “selecting one or more
information-rich bioparticles from the plurality of bioparticles”; (3)
“restricting the movement of information-rich bioparticles”; and (4)
“detecting bioparticle signatures from the information-rich bioparticles,” are
additional elements/steps. Final Act. 4. As such, they constitute well-
understood, routine, and conventional activity previously known to the
industry, and are therefore not sufficient to qualify as “significantly more”
than the recite judicial exception. Id.
By way of example, the Examiner points to Ecker, which teaches that
the “physical” steps recited in the claims all constitute well understood,
routine, and conventional activity. Final Act. 4. Specifically, the Examiner
finds that Ecker teaches the collection (e.g., via a swab and
collection/transport system such as a particle collector) of a biological
sample, comprising bioparticles that are shed (e.g., nucleic acids, proteins,
skin, hair, etc.) by a biological source organism (e.g., bioagent, virus,
bacteria, human, etc.), and that such shed bioparticles contain a plurality of
information-rich bioparticles (e.g., nucleic acids). Final Act. 4 (citing Ecker
col. 21, ll. 1–18, col. 28, ll. 30–36). The Examiner finds that Ecker also
teaches the selection and concentration of information-rich bioparticles by
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providing for the isolation of nucleic acids, amplification by PCR (e.g.,
selection by the application of primer/probe), and concentration (i.e.,
selecting and concentration system). Id. at 4–5 (citing Ecker col. 28, ll. 7–
36, col. 49, ll. 6–19, col. 50, ll. 6–18). The Examiner also finds that Ecker
teaches the restriction of information-rich bioparticles and detection of
bioparticle signatures by mass spectrometry (i.e., by a bioparticle signature
detector). Id. at 5 (citing Ecker cols. 28–30, ll. 42–3, col. 49, ll. 6–19, col.
51–58, ll. 60–28).
Appellant contends that the Examiner’s finding that claim 1 is
directed to the abstract idea of applying a pattern recognition strategy to
vectors overreaches the stated boundaries of the claim. App. Br. 19.
Appellant argues that claim 1 does not seek to tie up the classification of
vectors by pattern recognition; rather, it uses the technique in a very narrow
application domain (i.e., identification of sources of shed bioparticles) as a
tool for conducting a specific analysis on specific physical particles, leaving
the allegedly large universe of other possible applications of vector
classification by pattern recognition entirely open. Id. at 20.
Appellant contends that claim 1 is directly analogous to the example
given in MPEP § 2106.06(a).4 App. Br 20. Appellant asserts that merely
using a mathematical tool is not the same as attempting to monopolize it. Id.
Appellant argues that claim 1 (and its dependent claims) is therefore entitled
to a finding of eligibility under the “streamlined eligibility analysis” test of

4 MPEP § 2106.06(a) states: “As an example, a robotic arm assembly having
a control system that operates using certain mathematical relationships is
clearly not an attempt to tie up use of the mathematical relationships and
would not require a full analysis to determine eligibility.”
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the USPTO’s 2014 Guidance on Subject Matter Eligibility, 79(241) Fed.
Reg. 74618, 74625 (December 16, 2014) (the “2014 Guidance”). Id.
Appellant argues further that, even under the full two step subject
matter eligibility analysis of the 2014 Guidance, the first four physical steps
of Appellant’s claim 1 provide “significantly more” than an abstract idea,
thus satisfying Step 2B. App. Br. 20. Appellant notes that the sole reference
relied upon by the Examiner for the conclusion that these steps are “well
understood, routine, and conventional” is Ecker. Id. Appellant argues that
the problem with the Examiner’s characterization is that Ecker teaches the
analysis of nucleic acid sequences, but does not teach bioparticles at all,
much less bioparticles shed into the environment by a biological source. Id.
at 20–21. Nor, argues Appellant, do the methods taught by Ecker in any
way involve selecting information-rich bioparticles or detecting signatures
from bioparticles. Id. at 21. Appellant contends that the Examiner’s
allegedly conclusory statement that the method steps recited in the claim are
routine is insufficient to sustain the Examiner’s burden of making a prima
facie showing of ineligibility. Id.
Appellant argues further that it is submitted that, in evaluating
whether the first four steps of claim 1 provide “significantly more” than an
abstract idea, those steps must be considered, not in isolation, but in the
claimed combination. App. Br. 21. Appellant contends that the Examiner
cites no evidence to show that application of the physical steps of claim 1 to
shed bioparticles is in any way routine or conventional. Id. Appellant points
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to their expert Declarations5 as stating that the general belief in the field at
the time of Appellant’s filing was that such particles do not contain
sufficient information to make an identification of the source possible. Id.
Appellant further argues that the dependent claims, which add
considerable detail and specificity and take the physical steps of claim even
further, provide “significantly more” than the alleged abstract idea. App. Br.
21. Appellant asserts that the Examiner cites no evidence to support the
finding that these further details are routine or conventional. Id.
Appellant also points to dependent claim 6, which limits the
application of the method of claim 1 to the detection of a signature from “an
intact bioparticle shed from stratum corneum and/or hair.” App. Br. 21–22.
Appellant asserts that the Examiner has cited no evidence to support the
finding that application of the physical steps of claim 1 to such particles is in
any way routine or conventional. Id. at 22.

5 Appellant’s expert Declarations are the:

1. Declaration of Dr. Sarah J.R. Staton, filed January 13, 2016 (the “Staton
Declaration”)

2. Declaration of Dr. Thomas J. Taylor, filed January 13, 2016 (the “Taylor
Declaration”)

3. Declaration of Dr. Mark A. Hayes, filed January 14, 2016 (the “Hayes
Declaration”)

4. Declaration of Dr. Douglas Cochran, filed January 14, 2016 (the
“Cochran Declaration”)

5. Declaration of Dr. Vincent B. Pizziconi, filed January 15, 2016 (the
“Pizziconi Declaration”)
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In performing an analysis of patentability under Section 101, we
follow the framework set forth by the Supreme Court in Mayo Collaborative
Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012). We are also mindful
of, and guided by, the United States Patent and Trademark Office’s 2019
Revised Patent Subject Matter Eligibility Guidance, 84(4) Fed. Reg. 50–57
(January 7, 2019) (the “2019 Guidance”).
Appellant’s claim 1 recites: “A method for identifying a biological
source, the method comprising:….” Following the first step of the Mayo
analysis, we find that the claims are directed to a process, or method, and
therefore fall into one of the broad statutory categories of patent-eligible
subject matter under 35 U.S.C. § 101.
In the next step of the Mayo analysis, we determine whether the
claims at issue are directed to a nonstatutory, patent-ineligible concept, i.e., a
law of nature, a phenomenon of nature, or an abstract idea. Mayo, 566 U.S.
at 70–71. If the claims are so directed, we next consider the elements of
each claim both individually and “as an ordered combination” to determine
whether additional elements “transform the nature of the claim” into a
patent-eligible application. Id. at 78–79; see also Ariosa Diagnostics, Inc. v.
Sequenom, Inc., 788 F.3d 1371, 1375 (Fed. Cir. 2015). Specifically, the
Supreme Court considered this second step as determining whether the
claims recite an element or combination of elements that is “sufficient to
ensure that the patent in practice amounts to significantly more than a patent
upon the [ineligible concept] itself.” Mayo, 566 U.S. at 72–73.
More specifically, in this second step of the Mayo analysis, we look to
whether the claim recites one of the judicially-created exceptions to Section
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101, i.e., an abstract idea, a law of nature, or a natural phenomenon. See
2019 Guidance 54 (step 2A, prong 1).
If we determine that the claim recites a judicial exception, we then
determine whether the limitations of the claim reciting the judicial exception
are integrated into a practical application. Id. (Step 2A, Prong 2).
Finally, if we determine that the claim is directed to a judicially-created
exception to Section 101, we evaluate the claim under the next step of the
Mayo analysis, considering the elements of each claim both individually and
“as an ordered combination” to determine whether additional elements
“transform the nature of the claim” into a patent-eligible application. Mayo,
566 U.S. at 78–79; 2019 Guidance at 56 (Step 2B).
Claim 1 is directed to: “A method for identifying a biological source”
and recites the following steps: (1) collecting a plurality of bioparticles shed
by a biological source; (2) selecting one or more of the particles; (3)
restricting the movement of the one or more bioparticles; (4) detecting a
plurality of bioparticle signatures from the one or more bioparticles; (5)
processing the plurality of said bioparticle signatures into a multi-
dimensional vector by combining bioparticle signatures; and (6) identifying
the biological source based upon comparison of said multi-dimensional
vector to a standard multi-dimensional vector using a pattern recognition
strategy.
Put more succinctly, the claims are directed to collecting, detecting,
and isolating shed bioparticles, identifying individual characteristics of the
particles and deriving from them a multivariate vector (or tensor) and
comparing that against a reference multivariate vector as a means of
identifying the source of the bioparticle. See, e.g., Spec. ¶¶ 28–30.
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Steps (5) and (6) recite procedures that are essentially computational
in nature in that they involve deriving information from a sample concerning
the various properties of an isolated bioparticle or bioparticles, and
comparing them to a reference standard. See Spec. ¶¶ 28–30. Furthermore,
all of the steps recited in the claims may be performed by means that are
well understood in the art. See Spec. ¶ 67:
[S]ignals from the detector 400 generate bioparticle signatures
which are in tum processed into multi-dimensional vector 120.
The multidimensional vectors can be used to identify a
bioparticle source via one or more pattern classification and/or
recognition methods. These methods include binary tree
classifiers, (multilayer) neural network classifiers, Bayesian
network classifiers, support vector machine classifiers, Gaussian
process classifiers, k-nearest neighbor classifiers and Gaussian
mixture model classifiers, among others (see Duda R., et al.,
Pattern Classification, John Wiley & Sons, New York© 2001, the
contents of which are incorporated by reference herein).

Furthermore, it is not evident from Appellant’s Specification, nor does
Appellant argue, that the computational steps require any more specialized
processing steps than a general purpose computer processor. Because steps
(5) and (6) recited in the claim require nothing more than manipulation and
comparison of data (values) in a general purpose computer, according to
methods that are well understood in the art, we agree with the Examiner that
the claims recite an abstract idea, of the sort that could potentially be
performed mentally. Any such abstract idea, when coupled to a generic
computer performing functions that are within the regular repertoire of
computer functions, are not patent eligible. See CyberSource Corp. v. Retail
Decisions, Inc., 654 F.3d 1366, 1371 (Fed. Cir. 2011) (citing Parker v.
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Flook, 437 U.S. 584, 586 (1978)); see also CyberSource, 654 F.3d at 1372–
73.
Having determined that the claims recite an abstract idea, we next
look to see whether the claims are integrated into a practical application.
2019 Guidance at 54 (step 2A, prong 2). The Guidance provides additional
context for this analysis, stating that: “A claim that integrates a judicial
exception into a practical application will apply, rely on, or use 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 judicial exception.” Id. at 53.
In the present case, we find that the claims recite additional steps (1)–
(4), i.e., collecting, selecting, and restricting the movement of bioparticles,
and detecting, by any known methods, a plurality of bioparticle signatures.
We find that these steps involve the collection and processing of the
bioparticles (steps (1)–(3)) and detecting extant, inherent properties of the
bioparticles (step (4)). As such, we find that these steps recite data gathering
steps prior to the analytic steps (5) and (6) which, as we have explained,
embody the abstract idea of claim 1. Our reviewing court has held that
“mere ‘[data-gathering] step[s] cannot make an otherwise nonstatutory claim
statutory.’” Cybersource, 654 F.3d 1370 (citing In re Grams, 888 F.2d 835,
840 (Fed.Cir.1989) (quoting In re Meyer, 688 F.2d 789, 794 (C.C.P.A.
1982)).
As such, we find that the claims do not impose meaningful limits
upon the abstract idea recited in the claims.
We therefore turn to the next step of the Mayo analysis, considering
the elements of the claims both individually and “as an ordered
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combination” to determine whether the claims recite additional elements or
steps (i.e., “significantly more” than the abstract idea) that would suffice to
“transform the nature of the claim” into a patent-eligible application. Mayo,
566 U.S. at 78–79; 2019 Guidance at 56 (Step 2B).
Appellant disputes the Examiner’s finding that steps (1)–(4) of claim
1 do not recite “significantly more” than the abstract idea of steps (5) and
(6). See App. Br. 21. Appellant asserts that there is no evidence of record to
show that application of the physical steps (1)–(4) of claim 1 to shed
bioparticles is in any way routine or conventional. Id.
Our reviewing court has held that:
Whether something is well-understood, routine, and
conventional to a skilled artisan at the time of the patent is a
factual determination. Whether a particular technology is well-
understood, routine, and conventional goes beyond what was
simply known in the prior art. The mere fact that something is
disclosed in a piece of prior art, for example, does not mean it
was well-understood, routine, and conventional.

Berkheimer v. HP Inc., 881 F.3d 1360, 1369 (2018). We consequently look
to the evidence of record to make this factual determination.

Step (1): “collecting from the environment a plurality of bioparticles
shed by a biological source organism”

Appellant’s Specification discloses that:
In an embodiment of the method, a plurality of bioparticles (i.e.,
shed particulates) are first collected from the environment. The
environment from which the bioparticles are collected can be any
type of environment, including, for example, gaseous (i.e.,
airborne or aerosol bioparticles), liquid (e.g., bioparticles on or
suspended within a liquid), or solid or semi-solid (e.g.,
bioparticles on the surface of, or within, a solid or semi-solid).
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The bioparticles are collected by any suitable means. In a
preferred embodiment, the bioparticles are collected by a
particulate collection system. The particulate collection system
can comprise any of the collection systems known in the art. For
example, the particulate collection system may comprise a wet
cyclone, impact collector, electrostatic collector, or the like.

Spec. ¶ 42. Appellant’s Specification thus discloses that bioparticles may be
collected by any suitable means and collection systems for bioparticles are
generally known in the art.
Furthermore, none of Appellant’s expert Declarations opine that the
collection of bioparticles required any techniques or equipment that was not
well understood or not routine in the art. The Staton Declaration, by way of
example, states that:
In my opinion, an ordinary artisan at that time would have
regarded the identification of a biological source from shed
bioparticles as infeasible within the then-current state of the art,
and would have regarded shed particles collected from the
environment as not having sufficient information content to
make identification of the source organism possible.

Staton Decl. 1–2. Although Dr. Staton opines that a skilled artisan would
not have thought it feasible to obtain sufficient information from a shed
bioparticle to identify the source of the bioparticle, Dr. Staton does not attest
that the actual collection of such particles was not routine or conventional
activity. The other expert Declarations opine similarly.
Given the disclosure of Appellant’s Specification quoted supra, and
the lack of any testimony from Appellant’s experts to the contrary, we find
that that the collection of bioparticles was well understood, routine, or
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conventional, and that, consequently, this step does not add “significantly
more” to the claim.

Step (2): “selecting one or more information-rich bioparticles from
the plurality of bioparticles”

Appellant’s Specification discloses, with respect to this limitation,
that:
After collection of the bioparticles, one or more information-rich
bioparticles (i.e., “an information-rich bioparticle”) are selected
from the plurality of bioparticles and transferred to a bioparticle
signature detector (i.e., “the detector”). The information-rich
bioparticles are selected by any means known in the art. In a
preferred embodiment, a voltage source is used for selecting and
transferring a bioparticle of interest to the detector. The present
disclosure also contemplates transferring a bioparticle of interest
by known electric, magnetic or flow fields. It is understood in
accordance with the present disclosure that certain bioparticles
may be common to all samples and therefore may be non-
distinguishing. Other bioparticles will vary from sample to
sample and therefore will be indicative of those samples. Once
the sample composition is well characterized and understood,
only bioparticles which are distinguishing are selected and
processed for physical, chemical or biochemical assessment.

Spec. 44. Appellant’s Specification thus discloses that selection of
information-rich bioparticles can be selected “by any means known in the
art,” including (without elaboration) the use of a voltage source, implying
that such methods for selection are well understood, routine, and
conventional in the art. This implication is not contradicted by Appellant’s
expert Declarations, which are silent as to whether various selection methods
would have been routine and conventional in the art.
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Step (3): “restricting the movement of the one or more information-
rich bioparticles”

With respect to this limitation, Appellant’s Specification discloses
that:
In some embodiments, a bioparticle signature is generated by
first restricting or sequestering the movement of the bioparticle.
The movement of the bioparticle can be restricted or sequestered
by any suitable means, such as, for example, by use of an
electrical field, a physical flow, field gradient, isoelectric
focusing, and various mass spectrometry methods or
combinations thereof. In a particular embodiment, the
information-rich bioparticle is conventionally restricted or
sequestered by binding to a panel of compounds, e.g., antibodies
or peptides, including peptides prescreened for affinity to the
bioparticle source. The peptides can be generated by, for
example, phage display. Other types of compounds which would
interact with and bind or sequester bioparticles include but are
not limited to monomeric compounds, polymeric compounds,
aptamers, small molecules and the like. Such binding partners are
well known and appreciated by the skilled artisan.

In another embodiment, the movement of a bioparticle is
restricted by methods that utilize electrophoresis or
dielectrophoresis. The dielectrophoretic separation can be
achieved by any suitable means known in the art. For example,
dielectrophoretic separation can be achieved by placing
insulators into the electrophoretic field. Some other methods
known in the art for accomplishing dielectrophoresis include
flow separation, field-flow fractionation, stepped flow
fractionation, traveling wave dielectrophoresis, ratcheting
mechanisms including thermal ratchets and stacked ratchets, and
rotational dielectrophoresis, streaming dielectrophoresis, and
trapping dielectrophoresis. See, for example, Hughes, M. P., et
al., “Strategies for dielectrophoretic separation in laboratory-on-
a-chip systems,” Electrophoresis, 23(16) 2569-2582, (2002), the
contents of which are herein incorporated by reference.

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Spec. ¶¶ 46–47. Again, Appellant’s Specification discloses that means of
restricting the movement of the information rich bioparticles are known to
practitioners of the art, indeed, the use of binding compounds is “well
known and appreciated by the skilled artisan.”
Step (4): “detecting a plurality of bioparticle signatures from the one
or more information-rich bioparticles”

With respect to step (4), Appellant’s Specification discloses:
Once the movement of the bioparticle is restricted, a unique
bioparticle signature for the restricted bioparticle can be detected
using any suitable method, such as any spectroscopic,
electrochemical, mass spectroscopic or physical measurement.
In a preferred embodiment, a unique bioparticle signature for the
restricted bioparticle is detected by use of surface plasmon
resonance (SPR) on the restricted bioparticle. Any suitable type
of SPR technique can be used herein. For example, the SPR
technique can be a label-free and/or capillary electrophoresis
SPR technique. Surface plasmon resonance is a phenomena of
differential reflectance of light from a metallic gold-fluid
interface depending on the frequency of the light and the fluid
density within a few wavelengths of the surface; a shift in the
density, e.g.[,] from a binding particle or protein at the surface is
detectable as intensity change in reflected monochromatic light.
It is a commonly used method for detecting biomolecules, see,
e.g.[,] G. Ramsey, Commercial Biosensors: Applications to
Clinical, Bioprocess, and Environmental Samples (John Wiley
and Sons, New York, 1998) or H. Raether, “Surface Plasmons
on Smooth and Rough Surfaces and on Grating” (Springer-
Verlag, New York, 1988).

Spec. ¶ 48 (emphases added). The Specification thus discloses that methods
for detecting immobilized, information-rich bioparticles are known in the art
and, particularly, that surface plasmon resonance is, as a means of detecting
the bioparticles, “a commonly used method.”
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Appellant’s expert Declarations are silent with respect to whether
methods of information-rich bioparticle detection were known in the art to
be well understood, conventional, or routine. We therefore find that the
balance of evidence indicates that they were.
We therefore find that “physical steps” (1)–(4) of claim 1 recite no
more than steps of data gathering that would have been well understood,
routine and conventional by those practitioners skilled in the art. We
consequently conclude that these data gathering steps do not add
significantly more than the claimed abstract idea of steps (5) and (6).
Finally, we note that Appellant argues that “claim 1 does not seek to
tie up the classification of vectors by pattern recognition.” App. Br. 20. We
respond that, although avoidance of preemption of the claimed abstract ideal
is an object of the judicial exceptions to Section 101, it does not form a part
of our analysis as set forth by the Supreme Court in Mayo.
We conclude that the claims are directed to nonstatutory subject
matter, and we affirm the Examiner’s rejection of the claims.

B. The rejection of claims 1–3, 5, 6, 8, 9, and 11 as being obvious over
Ecker and Kasif

Issue
Appellant argues that the Examiner erred because Ecker fails to either
teach or suggest “identifying the biological source” of bioparticles “shed by
a biological source organism” and collected “from the environment.” App.
Br. 5.

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Analysis
The Examiner finds that Ecker teaches methods and apparatus for
identification of the source or origin (i.e., pathogen type) of an organism
from information-rich bioparticles in collected biological samples. Final
Act. 9 (citing Ecker Abstr., col. 21, ll. 1–18; col. 28, ll. 30–36). The
Examiner finds that Ecker teaches the collection of bioparticles that are shed
from an organism (e.g., from a swab and collection/transport system such as
a particle collector). Id. The Examiner finds that Ecker teaches that
bioparticles (e.g., nucleic acids, proteins, skin, hair, etc.) shed by a biological
source organism (e.g., bioagent, virus, bacteria, human, etc.) contain a
plurality of information-rich bioparticles (e.g., nucleic acids). Id. at 9–10.
The Examiner finds that Ecker further teaches that, by determining the
geographic origin of a bioagent, the identification of a criminal can be
facilitated. Final Act. 10 (citing Ecker col. 1, ll. 40–51). The Examiner
therefore finds that, employing the broadest reasonable interpretation of the
claim terms consistent with the Specification, Ecker teaches the
identification of a biological source. Final Act. 10–11.
The Examiner finds that Ecker does not expressly teach processing
detected bioparticle signatures into a multi-dimensional vector and
comparing it to a standard multi-dimensional vector. Final Act. 13.
However, the Examiner finds that Kasif teaches a representation of detected
sequences as objects in high-dimensional vector space. Id. at 13–14 (citing
Kasif Abstr., col. 2, ll. 42–54).
The Examiner concludes that it would have been obvious to a person
of ordinary skill in the art to have processed detected bioparticle signatures
into a multi-dimensional vector and generated a standard multi-dimensional
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vector for comparative analysis in a pattern recognition strategy as described
by Kasif, which teaches that high-dimensional/multi-dimensional vector
space permits the subsequent application of any number of statistical
learning techniques to train models for classification, clustering or indexing.
Final Act. 14–15 (citing Kasif col. 5, ll. 16–47, Fig. 2). The Examiner
further reasons that a person of ordinary skill would have been motivated to
combine the teachings of Ecker and Kasif because both are directed to
information-rich bioparticle analysis (e.g., DNA), and are therefore directed
to the same purpose and/or outcome. Id. at 15.
Appellant argues that bioparticles and the source of the bioparticles
are not the same thing. App. Br. 5. Appellant points, by way of example, to
one of its expert Declarations, which states:
In my opinion, an ordinary artisan would recognize the phrase
“bioparticles shed by a biological source organism,” as referring
to particles of a biological nature that have been shed from a
source organism. An ordinary artisan would understand the
“bioparticles” and the “source organism” to be distinct entities,
and would not consider merely identifying or characterizing
properties of the bioparticles to constitute “identifying the
biological source”, but would regard “identifying the biological
source” as referring to the source from which the bioparticles
were shed.

Hayes Decl. 1. Appellant acknowledges that Ecker teaches that
“determination of the geographic origin of a selected bioagent will facilitate
the identification of potential criminal identity.” App. Br. 6–7 (quoting
Ecker col. 1, ll. 43–45). However, Appellant argues, the only teaching in
Ecker of how to “determine geographic origin” consists of analyzing
samples that are taken from known geographic locations in the first place,
viz., “[b]y identifying a pathogen from samples acquired from a plurality of
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geographic locations, the spread of the pathogen to a given geographic
location can be determined.” Id. at 7 (quoting Ecker col. 6, ll. 33–36).
Appellant asserts that there is no teaching or suggestion in Ecker that would
enable a skilled artisan to identify the biological source of shed bioparticles,
not by already knowing the source from which they were obtained, but by
the claimed method of analyzing the bioparticles. Id.
Appellant next points to the Examiner’s finding that Ecker “indicates
identification of the biological source based upon detected bioparticle
signatures in comparison to a standard database.” App. Br. 7 (citing Final
Act. 13). Appellant contends, however, that the cited passages again relate
to the identification of pathogens, not to the identification of their sources.
Applicant contends that there is no teaching or suggestion in the passages of
Ecker cited by the Examiner (or in any other passage) that could be fairly
characterized as disclosing identification of the sources of shed particles. Id.
Appellant therefore submits that that the Examiner’ reliance on Ecker as
teaching “identifying the biological source,” as recited in the claims on
appeal, fundamentally mischaracterizes the subject matter of Ecker. Id.
We are not persuaded by the Examiner’s finding. Ecker summarizes
one embodiment of its invention thus:
The present invention is also directed to methods of predicting
the identity of a bioagent with a heretofore unknown base
composition signature by preparing a base composition
probability cloud plot from a plurality of base composition
signatures of the plurality of bioagents which includes the
heretofore unknown base composition, inspecting the base
composition probability cloud for overlap of the heretofore
unknown base composition with the cloud of a known bioagent
such that overlap predicts that the identity of the bioagent with a
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heretofore unknown base composition signature equals the
identity of the known bioagent.

Ecker col. 6, ll. 57–67. Ecker expressly defines the term “bioagent” as:
In the context of this invention, a “bioagent” is any organism,
cell, or virus, living or dead, or a nucleic acid derived from such
an organism, cell or virus. Examples of bioagents include, but
are not limited, to cells (including, but not limited to, human
clinical samples, bacterial cells and other pathogens) viruses,
fungi, and protists, parasites, and pathogenicity markers
(including, but not limited to, pathogenicity islands, antibiotic
resistance genes, virulence factors, toxin genes and other
bioregulating compounds). Samples may be alive or dead or in a
vegetative state (for example, vegetative bacteria or spores) and
may be encapsulated or bioengineered.

Id. at col. 10, ll. 9–19.
Appellant’s Specification defines the claim term “bioparticle” thus:
The bioparticles can be any material shed from an organism and
are typically biological in nature. The bioparticles can be
classified according to any of the general biological classes of
materials. For example, the bioparticle can be proteinaceous
(e.g., a protein, peptide, or antibody), nucleic acid-containing
(e.g., a nucleobase, nucleotide, oligonucleotide, or nucleic acid),
lipid-containing (e.g., fatty acid-containing), steroidal, one or
more small biological molecules, other types of biological
material, and combinations thereof. Some more specific
examples of bioparticles include cells (e.g., skin-derived or
epidermis cells), protein structures, hair, pathogenic and non-
pathogenic bacterial, viral, fungal, protozoal or other organisms,
and plant-derived material (e.g., pollen). Shed material from the
skin is particularly plentiful and includes particles from the outer
skin layer (e.g., stratum corneum) and other skin layers that
contain keratin. Though the bioparticles are largely organic, they
may also be inorganic. For example, the bioparticle can be a
mineral, such as talc. The bioparticle also need not be natural in
composition, but may be synthetic (e.g., particulates used in
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cosmetics or other toiletries). Often, the bioparticles are
constructed of aggregations of molecules or other bioparticles.
Such aggregations include cells, viruses, pollen grains, skin
flakes, hair, bacteria, and several other types of aggregations of
organic and inorganic molecules.

Spec. ¶ 43 (emphasis added).
Appellant’s Specification does not provide a definition of the claim
term “shed;” we consequently adopt the broadest reasonable definition of the
term consistent with the Specification. See Phillips v. AWH Corp., 415 F.3d
1303, 1316 (Fed. Cir. 2005). Merriam Webster defines “shed,” relevantly,
as “to eject, slough off, or lose as part of the normal processes of life,” and
we adopt that definition. See Merriam Webster, “Shed” available at:
https://www.merriam-webster.com/dictionary/shed (last visited April 15,
2020). Ecker also teaches that cells may be collected by swabs, and we find
that such cells that can be collected in such a manner are effectively “shed.”
See, e.g., Ecker col. 9, ll. 15–17; col. 21, ll. 8–10; col. 28, ll. 30–32.
Furthermore, although Appellant’s Specification does not expressly
define the claim term “environment,” Appellant’s Specification discloses
that:
The environment from which the bioparticles are collected can
be any type of environment, including, for example, gaseous (i.e.,
airborne or aerosol bioparticles), liquid (e.g., bioparticles on or
suspended within a liquid), or solid or semisolid (e.g.,
bioparticles on the surface of, or within, a solid or semi-solid).
The bioparticles are collected by any suitable means.

Spec. ¶ 42 (emphasis added). Given the broadness of these examples, we
find that Ecker’s examples of swabbing sloughed-off (i.e., “shed”) cells from
the throat of an individual teaches the limitation of the claims reciting
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“collecting from the environment a plurality of bioparticles shed by a
biological source organism.”
Nevertheless, although Ecker teaches identifying the bioparticle shed
by a source, the combination of Ecker and Kasif does not teach the
limitation of claim 1 reciting the use of its combined methods to “identify[ ]
the biological source” of the bioparticle. We interpret the claim term
“biological source,” in the context of the plain meaning of the rest of the
language of claim 1, and Appellant’s Specification, to mean the identity of
the organism, organ, or cell type that shed the bioparticle, and not the
identity of the bioparticle itself. Although Appellant’s Specification does
not expressly define the claim term “biological source,” the Specification
discloses that “[b]ioparticles may be identified as being from a particular
source which may then indicate the former or current presence of that
source” and that “[i]t is another object of various disclosed embodiments to
identify the particular source of shed bioparticles as originating from a
human being as opposed to other mammals …. [or] as originating from one
particular human being out of a group of other human beings.” Spec ¶¶ 3, 9,
10. The passages and examples of Ecker cited supra are directed to the
identification of the bioagent/bioparticle shed by the organism, and not to
the identity of the source organism that shed the bioparticle.
To provide an example of the difference, if an individual infected with
a pathogenic virus shed that virus as a detectable bioparticle, we interpret the
methods taught by Ecker as being usable to determine the nature and identity
of the shed pathogenic viral bioparticle, but not the identity of the infected
individual or organs or cells within that individual who shed the viral
bioparticle in the first place. See Ecker col. 6, ll. 25–67, Ex. 18.
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Because neither Ecker nor Kasif teach identification of a shed
bioparticle as a means of identifying the biological source of the detected
bioparticle, i.e., the organism that shed the bioparticle, we reverse the
Examiner’s rejection of claim 1. Furthermore, claims 2–12 depend from
claim 1 and we, for the same reasons, reverse the rejection of those claims.
Because we find these reasons to be dispositive of the appeal with
respect to claims 1–12, we do not reach Appellant’s additional arguments.

B. The rejection of claim 13 over Ecker and Kasif

Issue
Appellant argues that that the Examiner erred because Ecker does not
teach all elements of the apparatus recited in claim 13. App. Br. 12.

Analysis
Appellant asserts that Ecker does not purport to disclose an apparatus.
Id. Appellant contends that, for Ecker and Kasif to be cited as supporting
the rejection of Appellant’s apparatus claims, it would be necessary to find
not only that all elements of Appellant’s claimed method are disclosed, but
also that a skilled artisan would find it obvious how to construct an
apparatus to carry out that method. Id. Neither Ecker nor Kasif disclose any
such apparatus, or for that matter any apparatus, and Appellant contends that
the Examiner has cited no evidence from which it could be concluded that a
skilled artisan would find it obvious how to build such an apparatus. Id.
The Examiner responds that Ecker teaches methods and apparatus for
the identification of the source or origin (i.e., pathogen type) of an organism
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from information-rich bioparticles in collected biological samples that are
shed from an organism. Ans. 25. The Examiner finds that, by providing for
the collection (e.g., a swab and collection/transport system; i.e., a particle
collector) of a biological sample comprising bioparticles that are shed (e.g.,
nucleic acids, proteins, skin, hair, etc.) by a biological source organism (e.g.,
bioagent, virus, bacteria, human, etc.) where the bioparticles shed contain a
plurality of information-rich bioparticles (e.g., nucleic acids). Id. (citing
Ecker, Abstr., col. 21, ll. 1–18, col. 28, ll. 30–36).
We agree with Appellant. Appellant’s claim 13 is directed to “[a]n
apparatus for identifying a biological source organism from bioparticles shed
by the organism into the environment,” and recites that the apparatus
comprises: (1) a particle collector configured to collect a sample; (2) a
selection and concentration system coupled to the particle collector; and (3)
a pattern recognition system linked to the bioparticle signature detector.
Claim 13. The Examiner’s conclusory finding points to no teaching in either
Ecker or Kasif that teaches any such apparatus. Even if, arguendo, the
throat swabs taught by Ecker for sampling could be interpreted as
constituting “a particle collector configured to collect a sample” the
Examiner does not show how such a putative particle collector is coupled to
a “selection and concentration system” or linked to “a pattern recognition
system.” Because the claim is directed to an apparatus, i.e., a physical
device, the Examiner is under the burden of making a prima facie showing
of a teaching or suggestion of a device exhibiting at least all three
constitutive elements recited in claim 13. The Examiner has not done so,
and we reverse the Examiner’s rejection of claim 13 upon this ground.
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Furthermore, claims 14–20 depend, directly or indirectly, from claim
13. For the same reasons, we reverse the Examiner’s rejection of those
claims. Because we find this reversal dispositive of the appeal in this
respect, we do not reach Appellant’s additional arguments with respect to
these claims.

CONCLUSION
The Examiner’s rejection of claims 1–3, 5, 6, 8, 9, 11, and 12 under
35 U.S.C. § 101 is affirmed.
The Examiner’s rejection of claims 1–20 under 35 U.S.C.
§ 103(a) is reversed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1).

AFFIRMED-IN-PART

Claims
Rejected
35
U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–3, 5, 6, 8,
9, 11, 12
101 Nonstatutory subject
matter
1–3, 5, 6,
8, 9, 11, 12

1–3, 5, 6, 8,
9, 11, 13
103(a) Ecker, Kasif 1–3, 5, 6,
8, 9, 11, 13
1–6, 8, 9, 11,
13
103(a) Ecker, Kasif, Tellier 1–6, 8, 9,
11, 13
1–3, 5–19
(see fn.3)
103(a) Ecker, Kasif, Chou 1–3, 5–19
1–3, 5–13,
16–20
103(a) Ecker, Kasif, Chou,
Biacore
1–3, 5–13,
16–20
1–3, 5–13,
16–20
103(a) Ecker, Kasif, Chou,
Whelan
1–3, 5–13,
16–20
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Overall
Outcome
1–3, 5, 6,
8, 9, 11, 12
4, 7, 10,
13–20