Damir Janigro et al.

Patent Trials and Appeals Board

Mar 31, 2021

2020001771 (P.T.A.B. Mar. 31, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
15/264,682 09/14/2016 Damir Janigro FLO-005 2092
140000 7590 03/31/2021
Flocel Inc.
4415 Euclid Ave., Suite 421
Cleveland, OH 44103
EXAMINER
EOM, ROBERT J
ART UNIT PAPER NUMBER
1797
MAIL DATE DELIVERY MODE
03/31/2021 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAMIR JANIGRO and EDWARD J. RAPP
Appeal 2020-001771
Application 15/264,682
Technology Center 1700

Before ADRIENE LEPIANE HANLON, JENNIFER R. GUPTA, and
MERRELL C. CASHION, JR., Administrative Patent Judges.

GUPTA, Administrative Patent Judge.

DECISION ON APPEAL1
Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from the
Examiner’s decision to reject claims 1–20. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.

1 This Decision includes citations to the following documents: Specification
filed September 14, 2016 (“Spec.”); Final Office Action dated February 28,
2019 (“Final Act.”); Appeal Brief filed July 19, 2019 (“Appeal Br.”);
Examiner’s Answer dated November 8, 2019 (“Ans.”); and Reply Brief filed
January 7, 2020 (“Reply Br.”).
2 Appellant refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant
identifies the real party in interest as Flocel, Inc. Appeal Br. 2.
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CLAIMED SUBJECT MATTER
The invention is directed to a system and method for diagnosing
neurological conditions by analyzing a biological fluid sample. Spec. 1, ll.
12–16. Independent claim 1, reproduced below, is illustrative of the claimed
subject matter:
1. An assay device for determining a likelihood that a
subject has a neurological condition or to assess brain health
comprising:
a portable point of care (POC) assay device adapted to be
stored and/or carried, the POC assay device comprising:
an inlet adapted to receive a blood or other body
fluid sample taken from a subject;
at least one assay chamber in fluid connection with
the inlet adapted to perform a chemical assay on
the blood or other body fluid sample;
a known volume of solution or suspension
comprising at least one binding agent adapted to
elicit a chemical reaction and bind to a target
marker in the blood or other body fluid sample;
an input component adapted to allow a user to
input data and/or background information related
to the subject, the data and/or background
information comprising at least the subject's age,
race, and/or gender;
at least one sensor having a signal and adapted to
measure an electrical current output from the
chemical reaction, and being disposed in or about
the at least one assay chamber;
a processor comprising an algorithm, the processor
and algorithm adapted to process the signal from
the at least one sensor and the processor and
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algorithm adapted to output a determination based
at least in part on the signal from the at least one
sensor and at least in part on the data and/or
background information related to the subject, the
determination being a likelihood that the subject
has a neurological condition or an assessment of
brain health of the subject; and
an output device adapted to display or indicate at
least the determination.
Appeal Br. 62–63 (Claims App.).
Like claim 1, independent claims 8 and 14 are directed to an assay
device for determining a likelihood that a subject has a neurological
condition or to assess brain health; however, unlike claim 1, claim 8 recites
“a processor or processing device separate from the POC assay device,” and
claim 14 does not include any “POC assay device” recitation. Id. at 64–65,
66–67.
REJECTIONS
The Examiner maintains the following rejections on appeal (Final
Act. 2–17; Ans. 3, 17):
Rejection 1: Claims 1–20 are rejected under 35 U.S.C. § 112(a) as
failing to comply with the written description requirement;
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Rejection 2: Claims 1 and 14–193 are rejected under 35 U.S.C. § 103
as unpatentable over Liu4 in view of Venkatasubbarao;5 and
Rejection 3: Claims 2–13 and 20 are rejected under 35 U.S.C. § 103
as unpatentable over Liu, Venkatasubbarao, and Nemiroski.6
OPINION
Rejection 1 – Written Description
Claims 1–20 contain limitations directed to an algorithm and a
database adapted for determining the likelihood of a neurological condition
or an assessment of brain health. Appeal Br. 62–67 (Claims App.); Final
Act. 2. The Examiner finds that the original claims and originally filed
disclosure “fail[] to describe a computer, programming, equations, and
sufficient details such that one of ordinary skill in the art can reasonably

3 Claims 8–13 and 20 are listed in the statement of the rejection, but because
the Examiner does not address claims 8–13 and 20 in the body of the
rejection over Liu and Venkatasubbarao (Final Act. 5–10), as Appellant
correctly points out (Appeal Br. 39), we modify the statement of rejection to
omit claims 8–13 and 20 for clarity. The Examiner addresses claims 8–13
and 20 in the body of the § 103 rejection over Liu, Venkatasubbarao, and
Nemiroski (Rejection 3).
4 Yun Liu et al., A Sensitive Microchip-Based Immunosensor for
Electrochemical Detection of Low-Level Biomarker S100B, 25
Electroanalysis 1050–1055 (2013).
5 Srivatsa Venkatasubbarao et al., Field-based Multiplex and Quantitative
Assay Platforms for Diagnostics, Proc. SPIE 8029, Sensing Technologies for
Global Health, Military Medicine, Disaster Response, and Environmental
Monitoring; and Biometric Technology for Human Identification VIII,
80290P-1–80290P-11 (May 17, 2011).
6 Alex Nemiroski et al., Universal Mobile Electrochemical Detector
Designed for Use in Resource-Limited Applications, 111 Proceedings of the
National Academy of Sciences of the United States of America 11984–
11989 (2014).
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conclude that the inventor possessed the claimed subject matter at the time
of filing.” Id. at 2–3.
Appellant argues that the Specification provides
significant equations and data . . . which inform the skilled
artisan on how the algorithm will operate in specific
embodiments to take a measured value of a target marker and
compare it against known values and relationships in order to
determine if the measured value is indicative of an injury or
normal state.
Appeal Br. 8. Appellant argues that a person of ordinary skill in the art
would readily understand that the claimed algorithms were in the possession
of the inventors at the time of filing based on the disclosure in the
Specification, and that the claimed algorithm is more than reasonably
conveyed within the disclosure. Id.
Appellant’s arguments are not persuasive. To satisfy the written
description requirement, the Specification must describe the claimed
invention in sufficient detail that one skilled in the art can reasonably
conclude that the inventor had possession of the claimed invention. Vas-
Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562–63 (Fed. Cir. 1991). It is not
enough that one skilled in the art could write a program to achieve the
claimed function because the Specification must explain how the inventor
intends to achieve the claimed function to satisfy the written description
requirement. Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671,
681–683 (Fed. Cir. 2015); see also Examining Computer-Implemented
Functional Claim Limitations for Compliance With 35 U.S.C. 112, 84 Fed.
Reg. 57 (Jan. 7, 2019).
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We have reviewed the Specification, but as Appellant admits, “the
exact calculations and step-by-step operations of the algorithm for the
various adjustments and comparisons are not explicitly disclosed.” Appeal
Br. 7. Absent such information, we are not persuaded that the Examiner
erred rejecting claims 1–20 as lacking adequate written descriptive support
because the Specification, as originally filed, fails to reasonably convey to
those skilled in the art that the inventor had possession of the claimed
subject matter as of the filing date.
Appellant argues that “a person having ordinary skill in the art would
be able to extrapolate information from the data [in the Specification] . . .
and discern a mathematical relationship between the biomarker
concentration and the various demographic information.” Appeal Br. 8.
However, as we indicated previously, it is not enough that an artisan could
write a program to achieve the disclosed and claimed function because as
stated above, the Specification must explain how the inventor intends to
achieve the claimed function to satisfy the written description requirement.
See Manual of Patent Examining Procedure (“MPEP”) § 2161.01.I (9th ed.
rev. 10.2019 June 2020) (citing Vasudevan Software, Inc., 782 F.3d at 681–
83). Appellant does not direct us to any portions of the Specification that
explains how the inventor intends to achieve the claimed function of
determining the likelihood of a neurological condition or an assessment of
brain health.
Accordingly, we sustain the rejection of claims 1–20 under 35 U.S.C.
§ 112(a).
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Rejections 2 & 3 – Obviousness over Liu and Venkatasubbarao alone or in
combination with Nemiroski
Claims 1–7
Independent claim 1 recites an assay device comprising, among other
things:
a portable point of care (POC) assay device adapted to be stored
and/or carried, the POC assay device comprising:
. . .
an input component adapted to allow a user to input data
and/or background information related to the subject, the
data and/or background information comprising at least
the subject’s age, race, and/or gender;
. . .
a processor comprising an algorithm, the processor and
algorithm adapted to process the signal from the at least
one sensor and the processor and algorithm adapted to
output a determination based at least in part on the signal
from the at least one sensor and at least in part on the
data and/or background information related to the
subject, the determination being a likelihood that the
subject has a neurological condition or an assessment of
brain health of the subject; and
. . . .
Appeal Br. 62–63 (Claims App.).
The Examiner construes claim 1 as encompassing a device having a
plurality of separate components capable of being used together. Ans. 22
(“There is no positive recitation, in any of the claims, of any limitations
requiring the various components of the recited ‘POC assay device’ being
arranged into a single structural unit.”).
Liu teaches a microchip-based electrochemical immunosensor for
quantifying low level biomarker S100B. Liu Abstract. Liu teaches that it
uses a CHI 660C Electrochemical Workstation to process and record
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electrochemical measurements of its immunosensor. Liu 1052. The
Examiner finds that Liu’s microchip-based electrochemical immunosensor
corresponds to claim 1’s “portable point of care (POC) assay device adapted
to be stored and/or carried.” Final Act. 6. The Examiner finds that the CHI
660C Electrochemical Workstation in Liu corresponds to claim 1’s “input
component” and claim 1’s processor, but acknowledges that “Liu does not
explicitly disclose the processor comprises an algorithm which diagnoses the
subject based at least in part on the data and/or background information
related to the subject.” Final Act. 6–7.
Appellant points out that in claim 1 the “input component adapted to
allow a user to input data and/or background information related to the
subject,” and the “processor . . . adapted to process the signal from the at
least one sensor” are a part of a portable point of care (POC) device. Appeal
Br. 31. Appellant argues that Liu’s microchip-based electrochemical
immunosensor, which the Examiner finds corresponds to claim 1’s POC
device, does not include an input component or a processor as in claim 1.
Appeal Br. 22–24.
We begin our analysis with claim construction. It is well settled that,
during examination, the PTO must interpret terms in a claim using “the
broadest reasonable meaning of the words in their ordinary usage as they
would be understood by one of ordinary skill in the art, taking into account
whatever enlightenment by way of definitions or otherwise that may be
afforded by the written description contained in the applicant’s
specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
Claim 1 recites a portable POC device that includes, among other
things, “an input component adapted to allow a user to input data and/or
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background information related to the subject” and “a processor comprising
an algorithm, the processor and algorithm adapted to process the signal from
the at least one sensor and the processor and algorithm . . . .” According to
Appellant’s Specification, POC devices are “systems and/or devices . . .
designed to be portable, easy to carry and store, easy to carry and deploy
such that they can be kept ready or be otherwise readily available for
deployment quickly, easily, and without large equipment or resources
required.” Spec. 22, ll. 11–15. The Specification states that in some
embodiments, “the POC assay device will have an input component such as
a keyboard or touch screen or will be able to receive such information from
another device such as a computer, tablet, cell or smart phone, or the like” or
the patient specific information “may be entered into the separate device
comprising a processor.” Id. at 50, ll. 15–22. The Specification states that in
some embodiments “the processor may be a part of the assay device attached
to, embedded into, or otherwise integrated into the device” while other
embodiments, “may utilize a separate processor remote from the POC assay
device.” Id. at Spec. 44, ll. 6–9 (emphasis added). In light of the
Specification, we read the “input component” and the “processor” as part of
the portable POC assay device in claim 1.
The Examiner finds that Liu’s microchip-based electrochemical
immunosensor is “a portable point of care (POC) assay device” as in
claim 1. Final Act. 6. The Examiner finds that the CHI 660C
Electrochemical Workstation in Liu corresponds to claim 1’s “input
component” (id.); however, the CHI 660C Electrochemical Workstation is a
separate device, not part of Liu’s immunosensor. Further, as Appellant
points out, the CHI 660C Electrochemical Workstation is not itself a
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computer but instead operates in conjunction with a personal or professional
computer. Appeal Br. 22. Therefore, even if the CHI 660C Electrochemical
Workstation is an input component, the Examiner has not established that
the workstation is capable of performing the functions of claim 1’s “input
component,” i.e., allowing a user to input data and/or background
information related to the subject, the data and/or background information
comprising at least the subject’s age, race, and/or gender. Accordingly, on
this record, the Examiner has not established that Liu’s POC assay device,
i.e., Liu’s immunosensor, includes any input component as part of its device
let alone “an input component adapted to allow a user to input data and/or
background information related to the subject” as in claim 1.
The Examiner also finds that the CHI 660C Electrochemical
Workstation corresponds to claim 1’s “processor;” however, as discussed
above, the CHI 660C Electrochemical Workstation is a separate device, not
part of Liu’s POC assay device. Thus, the Examiner has also not established
that Liu teaches an assay device includes a processor as part of its device as
recited in claim 1.
The Examiner does not rely on Venkatasubbarao to cure the
deficiencies in Liu discussed above. Final Act. 7–10. Because the Examiner
has not established that Liu and Venkatasubbarao teach or suggest claim 1’s
POC assay device, the Examiner has not met the initial burden of setting
forth a prima facie case of obviousness for claim 1. Accordingly, we do not
sustain the § 103 rejection of claim 1. Because claims 2–7 depend from
claim 1, and the Examiner does not rely on Nemiroski to cure the
deficiencies of Liu and Venkatasubbarao discussed above regarding claim 1
(Final Act. 10–13), we also do not sustain the rejection of those claims.
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Claims 8–13
Independent claim 8’s assay device comprises a POC assay device
that includes the same “input component” as claim 1. Appeal Br. 64–65
(Claims App.). As with claim 1 above, we read the “input component” as
part of the POC assay device in claim 8. Unlike in claim 1, however, claim 8
recites “a processor or processing device separate from the POC assay
device.” Id.
As discussed above, the Examiner has not established that Liu’s POC
assay device, i.e., Liu’s immunosensor, includes any input component as
part of its device let alone “an input component adapted to allow a user to
input data and/or background information related to the subject” as in claim
8.
The Examiner does not rely on Venkatasubbarao or Nemiroski to cure
the deficiencies in Liu discussed above. Because the Examiner has not
established that Liu, Venkatasubbarao, and Nemiroski teach or suggest
claim 8’s POC assay device, the Examiner has not met the initial burden of
setting forth a prima facie case of obviousness for claim 8. Accordingly, we
do not sustain the rejection of claim 8 under 35 U.S.C. § 103 over Liu,
Venkatasubbarao, and Nemiroski. Because claims 9–13 depend from
claim 8, we also do not sustain the § 103 rejection of those claims.
Claim 14
Independent claim 14’s assay device does not recite a POC assay
device that includes an “input component” and/or “a processor” as recited in
claims 1 and 8. Appeal Br. 66–67 (Claims App.).
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As with claims 1 and 8, the Examiner finds that the CHI 660C
Electrochemical Workstation in Liu corresponds to claim 14’s “input
component,” “processor” and “output device.” Final Act. 7–8.
As with claims 1 and 8, Appellant argues that Liu does not teach
claim 14’s “input component” or “processor.” Appeal Br. 28–31. Appellant
also argues that Liu does not teach claim 14’s “output device.” Id. at 31–32.
Appellant’s arguments are not persuasive because unlike claims 1 and
8, we do not read claim 14 as requiring the recited elements, namely an inlet,
at least one assay chamber, known volume of solution or suspension, input
component, at least one sensor, processor and algorithm, and output device
to be part of a single device. Liu teaches a microchip-based immunosensor
for quantifying S100B, an important biomarker of neurological diseases. Liu
Abstract. Liu’s immunosensor is coupled with the CHI 660C
Electrochemical Workstation to detect S100B. Id. at Abstract, 1051. As
Appellant admits, the CHI 660C Electrochemical Workstation is an
electrochemical assay system that operates with a computer. Appeal Br. 29.
Because a personal computer includes input components (i.e., keyboard,
mouse), it would be capable of allowing a user to input data and/or
background information related to the subject, the data and/or background
information comprising at least the subject’s age, race, and/or gender.
Likewise, because a personal computer has a screen, it would be capable of
displaying or indicating at least the determination of the likelihood that the
subject has a neurological condition or an assessment of brain health of the
subject. See In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997)
(evaluating prior art for functional limitations recited in the claim). Thus, we
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are not persuaded that the Examiner reversibly erred in finding that Liu
teaches claim 14’s “input component,” “processor,” and “output device.”
Appellant argues that Venkatasubbarao does not teach the claimed
algorithm. Appeal Br. 32.
Appellant’s arguments are not persuasive. Venkatasubbarao teaches
that its diagnostic device to detect and measure biomarkers includes
software that is able to store data from previous measurements so that the
trends of different biomarkers can be compared for longitudinal studies.
Venkatasubbarao 80290P-1. Based on Venkatasubbarao’s teaching, we are
not persuaded that the Examiner erred in finding that Venkatasubbarao
teaches an algorithm or in finding that the algorithm (software) would be
capable of
process[ing] the signal from the at least one sensor and the
processor and algorithm adapted to output a determination
based at least in part on the signal from the at least one sensor
and at least in part on the data and/or background information
related to the subject, the determination being a likelihood that
the subject has a neurological condition or an assessment of
brain health of the subject.
Appellant argues that the Examiner’s motivation to combine is flawed
and does not meet the Examiner’s required burden of proof. Appeal Br. 33.
Appellant argues that “the purported benefit of performing longitudinal
studies in no way reads on the benefits of the present invention.” Id.
Appellant’s arguments are not persuasive. Establishing a prima facie
case of obviousness does not require combining the references for the
purpose of solving the same problem solved by the Appellant. See In re
Dillon, 919 F.2d 688, 693 (Fed. Cir. 1990); see also In re Lintner, 458 F.2d
1013, 1016 (CCPA 1972). Liu and Venkatasubbarao both disclose
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diagnostic devices for detecting and measuring biomarkers that aid in
detecting brain injury. Liu Abstract, 1050; Venkatasubbarao Abstract,
80290P-1. Appellant does not present persuasive arguments or evidence that
one of ordinary skill in the art would not have, through the use of no more
than ordinary creativity, incorporated Venkatasubbarao’s software into Liu’s
device “for the analysis of trends of different biomarkers for longitudinal
studies.” Final Act. 7.
In view of the foregoing, we sustain the rejection of claim 14 under 35
U.S.C. § 103 over Liu and Venkatasubbarao.
Claims 15–20
Claim 15 depends from claim 14 and recites “wherein the assay
device is a portable point-of-care (POC) device adapted to be stored and/or
carried.” In other words, claim 15 recites a POC assay device that includes
an input component and a processor like claim 1.
As discussed above with respect to claim 1, the Examiner has not
established that Liu teaches a portable point-of-care device, i.e., Liu’s
immunosensor, that includes any input component as part of its device let
alone “an input component adapted to allow a user to input data and/or
background information related to the subject.”
The Examiner does not rely on Venkatasubbarao to cure the
deficiencies in Liu discussed above. Because the Examiner has not
established that Liu and Venkatasubbarao teach or suggest claim 15’s POC
assay device, the Examiner has not met the initial burden of setting forth a
prima facie case of obviousness for claim 15. Accordingly, we do not sustain
the § 103 rejection of claim 15. Because claims 16–20 depend from claim
15, we also do not sustain the rejections of those claims.
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CONCLUSION
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–20 112(a) Written
Description
1–20
1, 14–19 103 Liu,
Venkatasubbarao
14 1, 15–19
2–13, 20 103 Liu,
Venkatasubbarao,
Nemiroski
2–13, 20
Overall
Outcome
1–20
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) (2018).
AFFIRMED