Adam Steel et al.

Patent Trials and Appeals Board

Mar 26, 2020

13757392 - (D) (P.T.A.B. Mar. 26, 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.
13/757,392 02/01/2013 Adam Steel HANLB.087A / P-09896 7150
95896 7590 03/26/2020
Knobbe, Martens, Olson & Bear, LLP
2040 Main Street
14th Floor
Irvine, CA 92614
EXAMINER
DEJONG, ERIC S
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
03/26/2020 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):
efiling@knobbe.com
ip.docket@bd.com
jayna.cartee@knobbe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ADAM STEEL,
THOMAS WOJECK, MICHAEL YOUNG, and MARK LARSEN

__________

Appeal 2019-002656
Application 13/757,392
Technology Center 1600
__________

Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL

Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 4, 5, 7, 10, 14–16, 19, 29–31, and
34–36. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant states that “the real party in interest is the
current assignee, BECTON, DICKINSON AND COMPANY of Franklin
Lakes, NJ.” Appeal Br. 4.
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STATEMENT OF THE CASE
The Specification explains that automated diagnostic instruments can
process and test multiple biological samples in parallel “to facilitate the
sample preparation and testing. By way of example, automated diagnostic
instruments can prepare samples for nucleic acid amplification assays, and
perform the amplification and detection.” Id. ¶ 34.
Despite the advantages of automated high throughput testing, “many
times, assay protocols are not compatible with each other on the same
instrument, either because of physical constraints on the instrument, or for
business reasons.” Id.
The Specification explains that, when attempting to use a single
diagnostic instrument to perform automated high throughput testing on
multiple samples, users previously “had to manually compare assay
protocols on a chart or table to determine whether they can be performed
concurrently on the same rack, or even on different racks of the same
instrument. Such manual approaches can be error prone, as well as
inefficient and labor intensive.” Id.
The Specification discloses that Appellant’s invention addresses the
difficulties in configuring a single automated diagnostic instrument to
perform multiple distinct assays in high throughput testing procedures. See
id. ¶ 35. In particular, Appellant’s invention allows “concurrent
performance of discrete assay workflows on an instrument when the assay
workflows are compatible, and can prevent the concurrent performance of
incompatible assay protocols within the same instrument. The methods
provided herein allow for improved reliability and ease of use when
performing an assay on an automated instrument.” Id.
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Appellant’s claim 1 is illustrative and reads as follows:
1. A method of performing an automated assay on a
plurality of samples, said method comprising:
providing an automated instrument comprising:
a housing,
a first area for performing automated assays, the first area
located within the housing,
a second area for performing automated assays, the
second area located within the housing, and
a space separating the first area from the second area,
wherein each of said first and second areas have a rack
configured to hold a plurality of samples to be processed
concurrently by the automated instrument according to a
plurality of different automated assay workflows using at least
one resource of the automated instrument that is shared among
the plurality of different automated assay workflows, wherein
each different automated assay workflow has an associated
unique assay definition file or user-defined protocol file,
wherein said assay definition file or user-defined protocol file
comprises a first-level compatibility index value and provides
one or more parameters for a resource of the automated
instrument used to perform the associated automated assay
workflow;
determining that the first assay workflow for a first
sample using a set of resources of the automated instrument is
compatible with the second assay workflow for a second
sample using the set of resources of the automated instrument
based at least in part on a first first-level compatibility index
value included in a first assay definition file or user-defined
protocol file for the first assay workflow being equal to a
second first-level compatibility index value included in a
second assay definition file or user-defined protocol file for the
second assay workflow, wherein said first-level compatibility
index value indicates that first values for parameters associated
with respective resources in the set of resources included in the
first assay definition file or user-defined protocol file and
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second values for the parameters associated with corresponding
resources in the set of resources included in the second assay
definition file or user-defined protocol file are each within a
resource compatibility range for the respective resource;
initiating the first assay workflow and the second assay
workflow, each according to its own one or more parameters,
concurrently at one of: (i) the first area, or (ii) the second area.
Appeal Br. 36–37.
The following rejections are before us for review:
(1) Claims 1, 4, 5, 7, 10, 14–16, 19, 29–31, and 34–36, under
35 U.S.C. § 101, as being directed to a judicial exception without including
additional elements that are sufficient to amount to significantly more than
the judicial exception itself (Ans. 3–4);
(2) Claims 1, 4, 5, 7, 10, 14–16, 19, 29–31, and 34–36, under
35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA) first paragraph, as failing
to comply with the written description requirement (Ans. 5–6); and
(3) Claims 1, 4, 5, 7, 10, 14–16, 19, 29–31, and 34–36, under
35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA) second paragraph, as being
indefinite (Ans. 6–7).
DISCUSSION
The Examiner’s Position
The Examiner finds that Appellant’s claims are “are directed to a
method and a computer system for performing an automated assay using
configured workstations comprising separated areas. The instant claims
only recite a function[] of . . . these configured workstations.” Ans. 3.
Moreover, the Examiner finds, Appellant’s claims “only provide for
the use of generic computer systems that are configured by a program to
perform functionally defined tasks” and are “open to using a generic
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computer merely to automate conventional and routine assay procedures.”
Id. at 3–4.
Based on those findings, the Examiner reasons that Appellant’s claims
only delineate an abstract idea in the functional tasks that
a[re] applied merely using a generic computer. The instant
claims are not limited to any specific programming or
configurations. Therefore, the claimed invention merely sets
using a generic computer to automate what amounts to nothing
more [than] conventional and routine assay activities.
Id. at 4.
In addition, the Examiner reasons:
The claims have further been amended to recite
additional functions and features to be performed automatically
by an “automated” system. This fails to delineate [anything]
new to the claims apart from additional abstract functions and
features to be realized using [the] “automated” system. The
claims have further been amended to add user-defined protocols
files as a source for definitions. This doesn’t alter the scope of
content of the claims because all programming and protocols
involved in the claims already is provided by a user. Further
the recitation of art recognized (as argued by applicant)
automated computers to perform automated functions still fails
to present anything significantly more to the instant claims than
a reliance of routine and conventional technology on which to
apply an abstract idea.
Therefore, for the reasons set forth above, the instant
claims are directed to nonstatutory subject matter.
Id.

Principles of Law
An invention is patent-eligible if it claims a “new and useful process,
machine, manufacture, or composition of matter.” 35 U.S.C. § 101. The
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Supreme Court has long interpreted 35 U.S.C. § 101 to include implicit
exceptions, however: “[l]aws of nature, natural phenomena, and abstract
ideas” are not patentable. Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 216
(2014).
In determining whether a claim falls within an excluded category, we
are guided by the Supreme Court’s two-step framework, described in Mayo
Collaborative Services v. Prometheus Laboratories., Inc., 566 U.S. 66
(2012) and Alice, 573 U.S. at 217–18 (citing Mayo, 566 U.S. at 75–77). In
accordance with that framework, we first determine what concept the claim
is “directed to.” See Alice, 573 U.S. at 219 (“On their face, the claims
before us are drawn to the concept of intermediated settlement, i.e., the use
of a third party to mitigate settlement risk.”).
Concepts determined to be abstract ideas, and thus patent ineligible,
include certain methods of organizing human activity, such as fundamental
economic practices (Alice, 573 U.S. at 219–20; Bilski v. Kappos, 561 U.S.
593, 611 (2010)); mathematical formulas (Parker v. Flook, 437 U.S. 584,
594–95 (1978)); and mental processes (Gottschalk v. Benson, 409 U.S. 63,
69 (1972)).
If the claim is “directed to” an abstract idea, we turn to the second
step of the Alice and Mayo framework, where “we must examine the
elements of the claim to determine whether it contains an ‘inventive
concept’ sufficient to ‘transform’ the claimed abstract idea into a patent-
eligible application.” Alice, 573 U.S. at 221 (quotation marks omitted).
Early in 2019, the PTO published revised guidance on the application
of § 101. USPTO, 2019 Revised Patent Subject Matter Eligibility Guidance,
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84 Fed. Reg. 50 (January 7, 2019) (“Memorandum” or “Office Guidance”).2
In light of comments received in response to the Office Guidance, the PTO
subsequently issued the October 2019 Update: Subject Matter Eligibility
(“October 2019 Update”).3
Following the Office Guidance and the October 2019 Update, under
Revised Step 2A, we first look to whether the claim recites the following:
(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, or mental processes); and
(2) additional elements that integrate the judicial exception into
a practical application (see MPEP § 2106.05(a)–(c), (e)–(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that
exception into a practical application, do we then look, under Step 2B of the
Office Guidance, to whether the claim:
(3) adds specific limitations beyond the judicial exception that
are not “well-understood, routine, conventional” in the field
(see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional
activities previously known to the industry, specified at a high
level of generality, to the judicial exception.
See Memorandum.

2 Available at https://www.govinfo.gov/content/pkg/FR-2019-01-
07/pdf/2018-28282.pdf.
3 https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_
update.pdf.
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Analysis
Office Guidance—Revised Step 2A, Prong 1
As noted above, the Examiner finds that the judicial exception to
patent-eligible subject matter recited in Appellant’s claims is an abstract
idea. See Ans. 4 (“[T]he instant claims only delineate an abstract idea in the
functional tasks that a[re] applied merely using a generic computer.”).
Although it appears that the Examiner considers the computer-related
functions recited in the claims to be abstract ideas, the Examiner does not
clearly identify which specific elements in Appellant’s claims are considered
to be abstract ideas. See id. at 3–4.
We note, nonetheless, that independent claim 1 recites a step of
“determining” whether a first assay is compatible with a second assay,
“based at least in part on a first first-level compatibility index value included
in a first assay definition file or user-defined protocol file.” Appeal Br. 36.
We note also that independent claim 16 recites receiving a “selection of a
first assay workflow” from a list of available assays, and further specifies
displaying a second list that excludes assays that are incompatible with the
assays in the first list, which, in excluding certain assays, also necessarily
involves performing a selection. Id. at 39.
Because they can be performed in the human mind, the claimed steps
of determining and selecting are mental steps that constitute abstract ideas.
See Office Guidance (84 Fed. Reg. at 52 (abstract ideas include “(c) Mental
processes—concepts performed in the human mind (including an
observation, evaluation, judgment, opinion”) (citations omitted); see also id.
n.14 (“If a claim, under its broadest reasonable interpretation, covers
performance in the mind but for the recitation of generic computer
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components, then it is still in the mental processes category unless the claim
cannot practically be performed in the mind.”) (Citing Intellectual Ventures I
LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016)).
Accordingly, applying Revised Step 2A, Prong 1, of the Office Guidance
(see 84 Fed. Reg. at 54), we determine that Appellant’s independent claims 1
and 16 recite judicial exceptions.
Office Guidance—Revised Step 2A, Prong 2
Having determined that Appellant’s independent claims 1 and 16
recite judicial exceptions under Revised Step 2A, Prong 1, of the 2019
Office Guidance, we turn to Revised Step 2A, Prong 2, of the Office
Guidance to determine whether claims 1 and 16 recite additional elements
that integrate the judicial exceptions into a practical application. See Office
Guidance (84 Fed. Reg. at 54–55).
In the present case, we find that Appellant’s claims 1 and 16 recite
additional elements that integrate the judicial exceptions into practical
applications. In addition to the determining and selecting steps, each of
claims 1 and 16 recites an automated instrument capable of performing a
plurality of different assays, the instrument including a housing, separated
first and second areas for performing the automated assays, and with each of
the areas having a rack configured to hold a plurality of samples to be
processed concurrently by the automated instrument. See Appeal Br. 36, 39.
Because claims 1 and 16 both recite a specific type of device that has
tangible elements arranged in a specific way, which device is an integral part
of the claim in that the first and second assay workflows that are determined
to be compatible to be carried out concurrently in the device are then
effected in the device, and therefore these claims implement the judicial
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exception in conjunction with “a particular machine or manufacture that is
integral to the claim,” see Office Guidance, 84 Fed. Reg. at 55. Thus, we are
persuaded that claims 1 and 16 integrate the judicial exception into a
practical application.
Indeed, because Appellant’s claims 1 and 16 are limited to using a
specific type of device that requires a particularized combination of features,
we agree with Appellant that, in addition to the abstract ideas, claims 1 and
16 recite elements sufficient to apply the judicial exceptions in a meaningful
way beyond a mere drafting effort designed to monopolize the exceptions
(mental steps) recited in the claim. See Office Guidance, 84 Fed. Reg. at 55.
The fact that automated assay instruments of the type claimed were known
in the art (see Spec. ¶ 65) does not persuade us that the claims are ineligible
for patenting. See Office Guidance, 84 Fed. Reg. at 54 (“[A] claim that
includes conventional elements may still integrate an exception into a
practical application, thereby satisfying the subject matter eligibility
requirement of Section 101.”).
In addition, as Appellant contends (see Appeal Br. 24), the
Specification discloses that implementing the compatibility determinations
in the manner recited in the claims provides a number of improvements in
the specific context of performing automated assays of biological samples in
the types of devices claimed. See Spec. ¶¶ 36, 78–80; see also MPEP §
2106.05(a) (“In determining patent eligibility, examiners should consider
whether the claim ‘purport(s) to improve the functioning of the computer
itself’ or ‘any other technology or technical field.’”) (Citing Alice, 134 S.
Ct. at 2359) (emphasis added). We note in particular that the Examiner has
not acknowledged, specifically addressed, or specifically disputed
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Appellant’s arguments as to the improvements provided by the inventions
recited in claims 1 and 16. See Ans. 9.
In sum, for the reasons discussed, we conclude that although
Appellant’s independent claims 1 and 16 recite mental processes, claims 1
and 16 recite additional elements sufficient to integrate the mental processes
into practical applications. Because we conclude, therefore, that claims 1
and 16 are not directed to subject matter that is ineligible for patenting, we
reverse the Examiner’s rejection of claims 1 and 16, and their dependent
claims, on that ground.
WRITTEN DESCRIPTION AND INDEFINITENESS
The Examiner’s Rejections
The Examiner bases the rejection for lack of written description, as
well as the rejection for indefiniteness, on the determination that Appellant’s
claims invoke means plus function elements which lack sufficient
descriptive support in the Specification, and therefore lack any definite
structure. See Ans. 5–8.
In particular, the Examiner determines that “[i]Independent claim 1
recites a series of means plus function language in the limitations of . . . a
first workstation area and a second workstation area.” Ans. 5, 7. In
addition, the Examiner determines, “[i]ndependent claim 16 also recite[s] a
series of means plus function language in the recite[d] limitations of a first
workstation area, a second workstation area, a program for performing an
automated assay with regard to the enunciated separated workstation areas.”
Id.
The Examiner reasons that “[t]hese terms are considered nonce terms
in that they do not provide any specific structure sufficient to perform the
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recited functions accompanying them in the instant claims.” Id. (citing
Williamson v. Citrix Online, LLC, 792 F.3d 1339 (Fed. Cir. 2015) and EON
Corp. IP Holdings LLC v. AT & T Mobility LLC, 785 F.3d 616 (Fed. Cir.
2015))
The Examiner finds that Appellant’s Specification “only reiterates the
functional language that is correlated to a generic means as is recited in the
instant claims. However, the instant disclosure is inadequate as it fails
specify any structure corresponding to the means as instantly claimed.” Ans.
6, 8 (citing Biomedino, LLC v. Waters Technologies Corp., 490 F.3d 946
(Fed. Cir. 2007).
Analysis
Under 35 U.S.C. § 112(f) and pre-AIA 35 U.S.C. § 112, sixth
paragraph, one may use means-plus-function language in a claim, rather than
reciting a specific structure for performing a claimed function, and such
language “restrict[s] the scope of coverage to only the structure, materials, or
acts described in the specification as corresponding to the claimed function
and equivalents thereof.” Williamson v. Citrix, 792 F.3d at 1347.
However, a claim limitation that does not use the term “means”
triggers the rebuttable presumption that 35 U.S.C. § 112(f) or pre-AIA
35 U.S.C. § 112, sixth paragraph, do not apply. See id. at 1349. That
presumption can be overcome “if the challenger demonstrates that the claim
term fails to recite sufficiently definite structure or else recites function
without reciting sufficient structure for performing that function.” Id.
Ultimately, when a claim does not use the term “means” in relation to
a limitation at issue, “[t]he standard is whether the words of the claim are
understood by persons of ordinary skill in the art to have a sufficiently
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definite meaning as the name for structure.” Id.
In the present case, we acknowledge that claim 1 recites an automated
instrument that has “a first area for performing automated assays” and “a
second area for performing automated assays.” Appeal Br. 36; see also
Appeal Br. 39 (claim 16 reciting automated instrument with first and second
“areas for performing automated assays”).
We are not persuaded, however, that the Examiner has explained why
a skilled artisan would fail to understand the scope of the structure of the
areas recited in claims 1 and 16. As noted above, and as Appellant contends,
the Specification discloses that “[a]utomated instruments which can perform
multiple assay protocols concurrently are known to those of skill in the art.”
Spec. ¶ 65. The Examiner does not acknowledge or address this disclosure
in Appellant’s Specification, nor does the Examiner explain specifically why
this, or any of the other disclosures in the Specification identified by
Appellant (see Appeal Br. 13–16), fail to demonstrate that a skilled artisan
would understand the structure of the areas recited in Appellant’s claims 1
and 16. See Ans. 9.
Accordingly, given that automated instruments capable of performing
multiple concurrent assay protocols were undisputedly known to skilled
artisans, we are not persuaded that the Examiner has explained sufficiently
why a skilled artisan would fail to understand the scope of the first and
second areas recited in Appellant’s claims 1 and 16. We are also not
persuaded, therefore, that the Examiner has sufficiently rebutted the
presumption that 35 U.S.C. § 112(f) and/or pre-AIA 35 U.S.C. § 112, sixth
paragraph, do not apply in this instance.
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Lastly, as noted above, the Examiner finds that Appellant’s claim 16
recites “a program for performing an automated assay with regard to the
enunciated separated workstation areas” which triggers the application of
35 U.S.C. § 112(f) or pre-AIA 35 U.S.C. § 112, sixth paragraph. Ans. 5, 7.
We are not persuaded.
We first note, as Appellant contends, that claim 16 does not recite a
“program.” See Appeal Br. 39–40. We note, nonetheless, that claim 16
recites a file that “provides one or more parameters for performing the
automated assay workflow.” Id. at 39. Given the Specification’s disclosure
that the parameters for performing multiple concurrent assay protocols were
undisputedly known to skilled artisans (see, e.g., Spec. ¶ 65), we are not
persuaded that the Examiner has explained sufficiently why a skilled artisan
would fail to understand the scope of the parameters recited in Appellant’s
claim 16.
In sum, for the reasons discussed, we are not persuaded that the
Examiner has shown sufficiently that Appellant’s claims 1 and 16 include
means plus function elements that trigger the application of 35 U.S.C.
§ 112(f) or pre-AIA 35 U.S.C. § 112, sixth paragraph. Because the
Examiner’s written description and indefiniteness rejections were premised
on the application of 35 U.S.C. § 112(f) or pre-AIA 35 U.S.C. § 112 to
Appellant’s claims 1 and 16, we reverse both of those rejections as to claims
1 and 16, and their dependent claims.
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CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)
/Basis
Affirmed Reversed
1, 4, 5, 7,
10, 14–16,
19, 29–31,
34–36
101 Eligibility 1, 4, 5, 7, 10,
14–16, 19,
29–31, 34–36
1, 4, 5, 7,
10, 14–16,
19, 29–31,
34–36
112(a) or
pre-AIA
112, first
paragraph
Lack of
Written
Description
1, 4, 5, 7, 10,
14–16, 19,
29–31, 34–36
1, 4, 5, 7,
10, 14–16,
19, 29–31,
34–36
112(b) or
pre-AIA
112, second
paragraph
Indefinitenes
s
1, 4, 5, 7, 10,
14–16, 19,
29–31, 34–36
Overall
Outcome
1, 4, 5, 7, 10,
14–16, 19,
29–31, 34–36

REVERSED