Ellume Pty Ltd

Patent Trials and Appeals Board

Jun 30, 2020

2019006455 (P.T.A.B. Jun. 30, 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.
14/672,789 03/30/2015 SEAN ANDREW PARSONS R0606.70007US00 8495
24353 7590 06/30/2020
BOZICEVIC, FIELD & FRANCIS LLP
BOZICEVIC, FIELD & FRANCIS
201 REDWOOD SHORES PARKWAY
SUITE 200
REDWOOD CITY, CA 94065
EXAMINER
MARCSISIN, ELLEN JEAN
ART UNIT PAPER NUMBER
1641
NOTIFICATION DATE DELIVERY MODE
06/30/2020 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):
docket@bozpat.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte SEAN ANDREW PARSONS
__________

Appeal 2019-006455
Application 14/672,789
Technology Center 1600
__________

Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and
TAWEN CHANG, 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 1–11, 14, 15, 18–26, 28–32, and 35–44.
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

STATEMENT OF THE CASE
Appellant’s invention involves the inventor’s realization that “by
detecting a relatively high level of LH [(luteinizing hormone)] in a

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies Ellume Pty Ltd. as the real party in
interest. Appeal Br. 3.
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biological sample, it can be determined that the person providing the sample
is relatively more likely to provide a false positive indication of pregnancy
due to higher background levels of hCG [(human chorionic gonadotropin)]
in the sample.” Spec. ¶ 27. “Equally, by detecting a relatively low level of
LH in a biological sample, it can be determined that the person providing the
sample is relatively less likely to provide a false positive indication of
pregnancy.” Id.
Appellant’s invention is thus directed to a pregnancy testing device
that adjusts the threshold hCG concentration indicative of pregnancy based
on whether the LH in the sample is above or below a particular threshold
concentration. See Spec. ¶ 28.
Appellant’s claim 1, the only independent claim on appeal, is
representative and reads as follows:
1. A pregnancy test device for identifying pregnancy in a
human or animal body based on a biological sample obtained
from the human or animal body, the test device comprising:
a lateral flow test strip comprising one or more test
portions configured to bind:
human chorionic gonadotropin (hCG), when
present, in the biological sample; and
luteinizing hormone (LH), when present, in the
biological sample; and
a reader that analyses the one or more test portions and
determines a level of hCG in the biological sample based on an
amount of hCG bound at the one or more test portions and
determines a level of LH in the biological sample based on an
amount of LH bound at the one or more test portions, wherein
the reader comprises a processor and a non-transitory computer-
readable memory medium, the non-transitory computer-
readable memory medium comprising instructions that cause
the processor to:
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determine which of a plurality of discrete LH ranges the
determined level of LH falls within, wherein the processor
associates a different hCG threshold level with each one of the
LH ranges,
wherein the plurality of discrete LH ranges comprises a
first LH range below a first LH threshold level and a second LH
range above the first LH threshold level, the first LH threshold
level being between 10 and 30 IU/L,
wherein a first hCG threshold level of between 1.0 and
3.0 IU/L is associated with the first LH range; and a second
hCG threshold level that is at least 2.0 IU/L greater than the
first hCG threshold is associated with the second LH range;
select the hCG threshold level that is associated with the
LH range which the determined level of LH falls within; and
identify pregnancy in the body if the determined level of
hCG is above the selected hCG threshold level..
Appeal Br. 47.
The sole rejection before us for review is the Examiner’s rejection of
claims 1–11, 14, 15, 18–26, 28–32, and 35–44 under 35 U.S.C. § 103(a)
over Lee,2 Polito,3 and Williams.4 Ans. 3–9.5
DISCUSSION
The Examiner’s Rejection
The Examiner cited Lee as disclosing a device “capable of identifying
both hCG and LH in a biological sample, as in the claimed device.” Ans. 4.
The Examiner conceded that Lee’s device differs from the device
recited in Appellant’s claims in that Lee “fails to teach a device that

2 US 2001/0021536 A1 (published Sept. 13, 2001).
3 US 6,136,610 (issued Oct. 24, 2000).
4 WO 2006/100415 A1 (published Sept. 28, 2006).
5 The Examiner withdrew rejections for lack of eligibility and obviousness-
type double patenting. See Ans. 10.
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comprises a reader comprising a processor and a non-transitory computer
readable memory medium comprising instructions to cause the processor to
perform the functions as claimed.” Ans. 4.
The Examiner cited Williams as also teaching a device capable of
measuring both hCG and LH, noting in particular Williams’s teaching as to
“the ability to use the measurement of LH in order to calculate therefrom an
hCG commencement day on which to start testing for hCG, see end of para
3, the device also configured to determine and display an estimated delivery
date and/or estimated date of conception from the hCG data.” Ans. 5.
The Examiner cited Polito as teaching that, when detecting analytes of
interest in biological samples via specific binding to a substrate, it is useful
to employ a positive control binding agent for the purpose of calibration, or
to generate a standard curve that aids in quantitation of the analyte of
interest. See Ans. 5–6.
The Examiner also cited Polito’s teaching that the relative intensity
level of binding of the control agent could be used to derive a cutoff value
for which an assay result may be considered positive. Ans. 6. The
Examiner cited Polito as teaching that its device included instructions for
performing the required comparisons between the degrees of binding of the
analyte of interest and the control binding agent. Id.
Based on the references’ combined teachings, the Examiner reasoned
that it would have been obvious to modify Lee’s device
to include as part of the pregnancy test device, the reader
comprising processor and non-transitory computer-readable
memory medium with instructions of Polito, in order to analyze
the test portions to determine the levels of each of the hCG and
LH, wherein the processor (via the instructions)
determines/relates stored information regarding the level of one
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marker (e.g., LH) and correlates it with a threshold level for the
other marker (i.e., determines a cutoff for the other, wherein the
other is the hCG), rendering a result based on the measured
level compared to the determined cutoff/threshold.
Ans. 7.
The Examiner determined that the instructions in claim 1, directing
the processor to adjust the hCG concentration threshold for identifying
pregnancy based on the LH concentration in the sample, are “functional
[limitations], as they describe what the reader (processor and memory) do,
rather than what it is.” Ans. 9; see id. (“[T]he functions, the ranges and the
specific values do not invoke/require any specific structure required
to[]perform the functions (no structure other than the reader comprising
processor and memory as claimed).”).
Therefore, the Examiner reasoned, because the device suggested by
the cited references is capable of performing the functions in the processor-
implemented instructions recited in Appellant’s claim 1, the cited references
render the device of claim 1 obvious:
The structure as taught by the combination of the cited
art is . . . considered capable of achieving the intended use(s) as
claimed, considering the reader as taught by Polito is capable of
determination of measured values at test portions (control and a
test analyte), and setting a level of a first analyte based on the
determined second analyte level (control analyte).
Ans. 9.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
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record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), although the
Supreme Court emphasized “an expansive and flexible approach” to the
obviousness question, id. at 415, it also reaffirmed the importance of
determining “whether there was an apparent reason to combine the known
elements in the fashion claimed by the patent at issue.” Id. at 418 (emphasis
added).
Thus, as the Federal Circuit has since explained, “obviousness
concerns whether a skilled artisan not only could have made but would have
been motivated to make the combinations or modifications of prior art to
arrive at the claimed invention.” Belden Inc. v. Berk-Tek LLC, 805 F.3d
1064, 1073 (Fed. Cir. 2015).
Ultimately, therefore, “[i]n determining whether obviousness is
established by combining the teachings of the prior art, the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir.
1995) (internal quotations omitted).
We agree with Appellants that a preponderance of the evidence does
not support the Examiner’s conclusion of obviousness. In particular,
Appellant persuades us that the Examiner has not explained sufficiently why
the cited references would have suggested a pregnancy testing device with a
memory containing the processor-implemented instructions recited in
Appellant’s claim 1.
As seen above, the pregnancy test device of Appellant’s claim 1
includes a processor and a memory with instructions that cause the processor
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to adjust the threshold hCG concentration for identifying pregnancy, based
on the amount of LH detected in a sample. See Appeal Br. 47. In other
words, the instructions in the memory control the conditions under which the
device identifies a sample to be indicative of pregnancy. That is, the
instructions in the memory control how the device functions.
Thus, contrary to the Examiner’s repeated contentions (see Ans. 12–
16), to show that the device of Appellant’s claim 1 would have been
obvious, the Examiner must show that the prior art would have suggested a
device with a memory having the specific instructions recited in claim 1.
See In re Lowry, 32 F.3d 1579, 1583–84 (Fed. Cir. 1994) (claim limitations
regarding organization of data in memory held to distinguish over prior art);
In re Noll, 545 F.2d 141, 148 (CCPA 1976) (“[T]he claimed invention . . .
comprises physical structure, including storage devices and electrical
components uniquely configured to perform specified functions through the
physical properties of electrical circuits to achieve controlled results.
Appellant’s programmed machine is structurally different from a machine
without that program.”).
We are not persuaded that the Examiner has shown sufficiently that
the cited references would have suggested a device with a memory having
the specific instructions recited in claim 1. We acknowledge the disclosure
in the Lee reference that devices of the type that identify pregnancy by
detecting hCG can also be used for detecting LH. See Lee ¶¶ 4–5.
We also acknowledge Williams’s teaching that determining LH
concentration in a sample can aid in estimating an implantation date, making
it easier to decide when to start testing for hCG. See Williams 10; see also
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id. at 10–11 (disclosing test kits including a single stick that can determine
both LH and hCG concentrations).
We also acknowledge Polito’s disclosure that, in devices like those of
Lee and Williams that detect analytes through substrate binding, it is useful
to employ a control binding agent to calibrate the device and assign a signal
to cutoff value above which a positive result may be identified. See Polito
5:41–7:10.
The Examiner does not persuade us, however, that any of the cited
references, including when viewed in combination with each other, includes
teachings that are sufficiently specific to suggest a device having the
particular configuration required by Appellant’s claim 1, which adjusts the
threshold hCG concentration for identifying pregnancy based on the amount
of LH detected in a sample. We therefore reverse the Examiner’s rejection
of claim 1, and its dependent claims 2–11, 14, 15, 18–26, 28–32, and 35–44.

CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/
Basis
Affirmed Reversed
1–11, 14, 15,
18–26, 28–
32, 35–44
103(a) Lee, Polito,
Williams
1–11, 14, 15,
18–26, 28–32,
35–44

REVERSED