Theranos, Inc.

Patent Trials and Appeals Board

Mar 4, 2021

2020001873 (P.T.A.B. Mar. 4, 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.
14/639,986 03/05/2015 Deborah Sloan 2024.502A 6138
107075 7590 03/04/2021
Labrador Diagnostics LLC
160 Foss Creek Cir #2369
Healdsburg, CA 95448
EXAMINER
GORDON, BRIAN R
ART UNIT PAPER NUMBER
1798
NOTIFICATION DATE DELIVERY MODE
03/04/2021 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):
docketing@labradordiagnostics.com
eofficeaction@appcoll.com
patents@labradordiagnostics.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte DEBORAH SLOAN, ELIZABETH A. HOLMES, PEY-JIUN KO,
EDWINA LAI, ADRIT LATH, and CHANNING ROBERTSON
____________

Appeal 2020-001873
Application 14/639,986
Technology Center 1700
____________

Before CATHERINE Q. TIMM, KAREN M. HASTINGS, and
MERRELL C. CASHION, JR., Administrative Patent Judges.

CASHION, Administrative Patent Judge.

DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 38–41, 45, and 47–58. We have
jurisdiction under 35 U.S.C. § 6(b). We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies “Theranos IP Company, Inc.” as the
real party in interest. Appeal Br. 2.
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The invention relates generally to a device for collecting a bodily fluid
sample from a subject. Spec. ¶ 6. Claim 38 illustrates the subject matter on
appeal and is reproduced below:
38. A device for collecting a bodily fluid sample from
a subject, the device comprising:

a first portion comprising at least one fluid collection
location leading to at least two sample collection pathways
configured to draw the fluid sample therein via a first type of
motive force;

a second portion comprising a plurality of sample
containers for receiving the bodily fluid sample collected in the
sample collection pathways, the sample containers operably
movable to be in fluid communication with the sample
collection pathways, whereupon when fluid communication is
established, the containers provide a second motive force
different from the first motive force to move a majority of the
bodily fluid sample from the pathways into the containers; and

a separation material along one of the sample collection
pathways, the material configured to remove formed
components from the sample when outputting to at least one of
the sample containers;

wherein the other of the two sample collection pathways
is from an inlet port of the first portion to an outlet port of the
first portion and is without the separation material and outputs
unfiltered sample from the outlet port.

The Examiner maintains the following rejections from the Final
Office Action dated July 13, 2018:
I. Claims 38, 39, 45, 50, and 58 rejected under pre-AIA 35 U.S.C.
§ 103(a) as unpatentable over Huang (WO 2011/079217 A1,
published June 30, 2011, and relying on US 2012/0258459 A1 to
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Huang, published October 11, 2012, as the English equivalent) and
Legg (US 4,343,705, issued August 10, 1982).

II. Claims 40, 41, 47, and 55–57 rejected under pre-AIA 35 U.S.C.
§ 103(a) as unpatentable over Huang, Legg, and Kartalov (US
2012/0085648 A1, published April 12, 2012).2

III. Claim 48 rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Huang, Legg, and Blankenstein (US 2007/0269893
A1, published November 22, 2007).

IV. Claim 49 rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Huang, Legg, and Leach (US 5,505,721, issued
April 9, 1996).

V. Claims 51–54 rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Huang, Legg, and Davis (US 2007/0031283 A1,
published February 8, 2007).

Appellant presents specific arguments only for the following claims:
(a) claim 38 (Rejection I) and (b) claims 40, 41, and 57 as a group (Rejection
II). See generally Appeal Br. Appellant relies on these arguments to
address the rejections of the remaining claims. Id. Accordingly, we select
claims 38 and 40 as representative of the subject matter claimed and decide

2 Both the Examiner and Appellant agree that claim 47 has been rejected.
Appeal Br. 2; Final Act. 1. Claim 47 was once subject to a rejection under
35 U.S.C. § 112, second paragraph, and on the ground of nonstatutory
double patenting (see Non-Final Action dated March 23, 2017), but these
rejections were either withdrawn or not maintained in a prior Final Office
Action dated January 12, 2018. While it appears that claim 47 was not
explicitly included in a prior art rejection, after review of the prosecution
record, claim 47 is similar to claims 40 and 41 in that all of these dependent
claims further limit claim 38 by reciting a distributor structure. Accordingly,
we consider it harmless error that the Examiner omitted claim 47 from this
rejection.
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the appeal as to all grounds of rejections based on the arguments presented
for these claims.

OPINION
After review of the respective positions the Appellant presents in the
Appeal and Reply Briefs and the Examiner presents in the Final Office
Action and the Answer, we AFFIRM the Examiner’s rejections of claims
38–41, 45, and 48–58 under 35 U.S.C. § 103(a) for essentially the reasons
the Examiner presents. Our reasoning follows.
Claim 38 (Rejection I)
The Examiner finds that Huang teaches a device for collecting a
bodily fluid sample from a subject that differs from the claimed invention in
that Huang does not specifically teach (1) wherein at least one of the sample
collection pathways comprises a fill indicator to indicate when a minimum
fill level has been reached and (2) at least one of the sample containers can
be engaged to be in fluid communication with at least one of the sample
collection pathways. Final Act. 5–6. The Examiner finds that Legg,
directed to the analogous art of blood separating systems, teaches a cartridge
40 having two reservoirs, one of the reservoirs 44 having a fill line 45. Final
Act. 6. The Examiner finds Legg teaches the use of fill lines to visualize the
amount of blood specimen to be fractionated. Final Act. 6; Legg col. 5, ll.
10–27. Legg also shows the reservoirs are movable to be in fluid
communication with at least one of the sample collection pathways. Legg
Figures 1, 7, 8. The Examiner determines it would have been obvious to one
of ordinary skill in the art to modify Huang’s sample collection pathways to
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include a fill line, as taught by Legg, to visualize the amount of blood
sample to be fractionated. Final Act. 6–7.
Appellant argues that Huang’s Figure 15A embodiment does not teach
the claim limitation of “a first portion comprising at least one fluid
collection location leading to at least two sample collection pathways
configured to draw the fluid sample therein via a first type of motive force.”
Appeal Br. 4. Appellant contends Huang’s Figure 15A embodiment teaches
a single pathway from feed inlet 502 with a filter 508 directly in the pathway
of a sample flow that leads to filtrate outlet 507 and retentate outlets 503. Id.
at 5. According to Appellant, the outlet 503 is a retentate outlet from filter
module 181, meaning that the output is already filtered. Appeal Br. 7 (citing
to Huang Figures 18A). That is, Appellant contends that Huang’s Figures
15A embodiment does not lead to an unfiltered sample because all of the
input at inlet 502 encounters the filter 508. Id. In the Reply Brief, Appellant
further contends that Huang’s retentate 503 is not an “unfiltered sample” as
recited in claim 38 because Huang’s Figure 18A embodiment includes a
double filter such that the retentate 510, presumably corresponding to the
retentate 503 of Huang’s Figure 15A embodiment, was previously filtered.
Reply Br. 5–6.
Appellant’s arguments do not identify error in the Examiner’s
determination of obviousness.
As a preliminary matter, our review of the Examiner’s analysis and
Appellant’s arguments requires that the claims must first be construed to
define the scope and meaning of each contested limitation. See Gechter v.
Davidson, 116 F.3d 1454, 1457 (Fed. Cir. 1997).

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Claim 38 recites:
wherein the other of the two sample collection pathways
is from an inlet port of the first portion to an outlet port of the
first portion and is without the separation material and outputs
unfiltered sample from the outlet port.

To give proper weight to the evidence of record and the respective positions
of Appellant and the Examiner, we must first determine what does
“unfiltered sample” means. Thus, our review of the grounds of rejection of
the appealed claims necessarily entails the interpretation of the scope of the
appealed claims, giving the broadest reasonable interpretation to the terms
thereof consistent with the written description provided in Appellant’s
Specification as it would be interpreted by one of ordinary skill in this art.
See In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
Terms in the appealed claims must be given their broadest reasonable
interpretation including the ordinary meaning unless another meaning is
intended by Appellant as established in the written description of their
Specification. See, e.g., In re Zletz, 893 F.2d 319, 321–22 (Fed. Cir. 1989).
When the Specification does not contain an express definition, a reasonable,
supported interpretation of the appealed claims that differs from that urged
by Appellant can be used to determine the patentability of the claims.
Morris, 127 F.3d at 1055–56 (“Absent an express definition in their
specification, the fact that appellants can point to definitions or usages that
conform to their interpretation does not make the PTO’s definition
unreasonable when the PTO can point to other sources that support its
interpretation.”). Indeed, “[i]t is the applicants’ burden to precisely define
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the invention, not the PTO’s. See 35 U.S.C. § 112 ¶ 2 [statute omitted].”
Morris, 127 F.3d at 1055–56.
The premise of Appellant’s arguments is that Huang’s retentate 503 is
not an “unfiltered sample” as recited in claim 38 because it comes into
contact with the filter 508 or, based on Huang’s Figure 18A embodiment,
the retentate 503 was previously filtered.
First, we note that Appellant does not direct us to any portion of the
Specification that defines the term “unfiltered sample” and we find none.
Secondly, Huang defines the term “retentate” as a fluid and particle output
that comprises particles retained by a filter or that do not pass through a
filter. Huang ¶ 194. That is, Huang defines the retentate as the portion of
the sample that does not pass through a filter and, thus, it is an “unfiltered
sample.” Huang ¶ 194; see Ans. 12. While Appellant contends that an
unfiltered sample (retentate) has to be compositionally the same as the
sample provided at the first inlet (Reply Br. 5), Appellant does not direct us
to any portion of the Specification or other objective evidence that supports
this contention. In fact, Appellant’s contention contradicts Huang’s
definition of “unfiltered sample” because Huang recognizes that the retentate
may include particles that are retained by the filter that produces the filtrate
(“filtered sample”). Based on this analysis, we find that “unfiltered sample”
describes a sample that does not go through a filter.
Turning to Appellant’s arguments, we note that Appellant relies on
Huang’s Figure 18A embodiment to address the Examiner’s rejection based
on Huang’s Figure 15A embodiment. Huang clearly identifies these
embodiments as separate and distinct embodiments of the disclosed
invention, each with their specific filter arrangement. Huang ¶¶ 241
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(“Another embodiment of the dual filter module is shown in FIG. 15, where
two filter modules form mirror images and share one filtrate chamber.”), 245
(“In one embodiment, shown in FIG. 18A, a cascade module 180 comprises
a first filter module 181 and a second module 182.”). Therefore, Appellant’s
reliance on Huang’s Figure 18A embodiment does not address the rejection
the Examiner presents. Moreover, given that retentate 503 does not pass
through a filter, Appellant fails to explain adequately why retentate 503 of
Huang’s Figure 15A embodiment is not an unfiltered sample as recited in
claim 38.
Appellant argues that Huang does not teach movable containers that
provide the motive force to move a majority of the sample from the
pathways. Appeal Br. 6.
With respect to the use of containers in Huang’s device, there is no
dispute that Huang separates a sample into a retentate and a filtrate. See
generally Appeal Br. and Final Act; see Huang Figure 15A, ¶¶ 194–195.
One skilled in the art would reasonably infer from this disclosure that
Huang’s device provides some form of container in fluid communication
with the respective outlets for the retentate and filtrate streams to receive
these portions of a sample. See In re Fritch, 972 F.2d 1260, 1264–65 (Fed.
Cir. 1992) (holding that a reference stands for all of the specific teachings
thereof as well as the inferences one of ordinary skill in the art would have
reasonably been expected to draw therefrom). The Examiner finds that Legg
teaches that it is known to use reservoirs/containers for this purpose. Final
Act. 6; Ans. 14. In view of the above, Appellant fails to explain adequately
why one of ordinary skill in the art, using no more than ordinary creativity,
would not have been capable of modifying Huang’s device to include
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sample containers for receiving the retentate and filtrate streams where the
sample containers are operably movable to be in fluid communication with
the sample collection pathways. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
421 (2007) (“A person of ordinary skill is also a person of ordinary
creativity, not an automaton.”); In re Sovish, 769 F.2d 738, 743 (Fed. Cir.
1985) (presuming skill on the part of one of ordinary skill in the art).
In terms of the use of different motive forces to draw the sample into
the device and to move the sample portions into the collection containers,
the Examiner notes that Huang discloses a number of exemplary motive
forces that can be used to drive a sample from the inlet to the outlet that can
be used alone or in combinations for such a purpose. Ans. 10; Huang ¶ 239.
Moreover, Huang discloses the use of vacuum as one of the exemplary
motive forces. Huang ¶ 239. The use of vacuum as a motive force to move
fluids generally requires that it be applied downstream of the fluid flow,
particularly near or at the point where the fluid is to be received. Thus, one
skilled in the art would reasonably infer from Huang’s disclosure that the
use of vacuum as a motive force would occur at the point where the sample
portions are collected (i.e., the containers). Fritch, 972 F.2d at 1264–65.
Thus, there is a reasonable basis for one skilled in the art to arrive at the
claimed invention from the combined teachings of the cited art. In re
O’Farrell, 853 F.2d 894, 904 (Fed. Cir. 1988) (“For obviousness under
§ 103, all that is required is a reasonable expectation of success.”).
Appellant’s argument fails to address adequately the rejection the Examiner
presents. In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986); see
also In re Keller, 642 F.2d 413, 425–26 (CCPA 1981) (citations omitted)
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(“[T]he test [for obviousness] is what the combined teachings of the
references would have suggested to those of ordinary skill in the art.”).
Appellant argues that Huang does not teach a distributed pattern of
channels over the filtration material. Appeal Br. 10.
Appellant’s argument is unavailing because claim 38 does not recite a
distributed pattern of channels over the filtration material. Therefore,
Appellant has not identified reversible error in the Examiner’s determination
of obviousness.
We have fully considered Appellant’s arguments that the Examiner
benefitted of impermissible hindsight in arriving at the claimed invention
from the combined teaching of the cited art with respect to the provision of a
fill line in a container. Appeal Br. 13. We are unpersuaded by these
arguments for the reasons the Examiner presents and we give above with
respect to providing Huang’s device with container collectors for the
portions of the sample processed. Final Act. 6–7; Ans. 14.

Claim 40 (Rejection II)
Claim 40 recites “a distributor adjacent the separation material to
define an interface that provides a multi-mode sample propagation pattern
wherein at least a first portion is propagating laterally within the separation
material and a second portion is propagating through channels of the
distributor over the separation material.” That is, the distributor
preferentially spreads the sample over the separator. Spec. ¶ 100.
The Examiner finds Huang’s Figures 15A and 15B disclose a
separation material that provides a multi-mode sample propagation pattern
where the sample fluid takes multiple pathways through the separator as it
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flows through the device. Final Act. 7. According to the Examiner, Figures
15A and 15B show at least a first portion is propagating laterally within the
separation material and a second portion is propagating over the separation
material. Id. By laterally, we find that the Examiner means across the
surface of filter 508. The Examiner finds that Huang does not specifically
disclose a distributor placed as claimed. Id. The Examiner finds that
Kartalov teaches it was known to use a distributor interfacing with a
separator (filter element) where the distributor comprises channels that
provide a multi-mode sample propagation flow pattern over the separator
and which extends beyond an external perimeter of the separator. Final Act.
8; Kartalov Figures 1–4; ¶¶ 37–49. The Examiner determines that it would
have been obvious to a person of ordinary skill in the art to modify Huang’s
device to include a distributor such as Kartalov’s to increase throughput and
reduce clogging of the filter element. Final Act. 8; Kartalov ¶ 46.
Appellant argues that Kartalov does not teach a distributor as claimed
because Kartalov’s channel 300 is actually narrower than the lower channels
310 and 320. Appeal Br. 14. Thus, according to Appellant, Kartalov’s top
channel is not as wide and does not distribute sample laterally due to the
lower channels being wider than the top channel. Id. at 15. Appellant also
contends that the Examiner has not shown that there is a reasonable
expectation of success or of any benefit to combine the narrow top channel
300 of Kartalov with Huang (or how to make the combination work). Id. at
16.
Appellant’s arguments do not identify reversible error in the
Examiner’s determination of obviousness.
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Kartalov discloses horizontal (lateral) distribution of a sample across
the length of a filter element before, or as part of, the sample passes through
the filter. Kartalov, Figure 1. While Appellant argues that the structure of
Kartalov’s distributor is different from Appellant’s disclosed distributor, we
note that the claim does not recite any specific structure for the claimed
distributor other that ensuring lateral distribution of the sample across a
filter media to ensure better passage of the sample through the filter media.
Appellant fails to argue that Kartalov’s distributor does not perform these
functions.
We have considered Appellant’s remaining arguments for this claim
but find them unavailing because they do not address the Examiner’s reasons
to combine the references. Appeal Br. 15; Final Act. 8.
Arguments not specifically addressed are deemed not persuasive for
the reasons the Examiner presents.

DECISION SUMMARY
In summary:

Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
38, 39, 45, 50,
58
103(a) Huang, Legg 38, 39, 45, 50,
58

40, 41, 47, 55–
57
103(a) Huang, Legg,
Kartalov
40, 41, 47, 55–
57

48 103(a) Huang, Legg,
Blankenstein
48
49 103(a) Huang, Legg,
Leach
49
51–54 103(a) Huang, Legg,
Davis
51–54
Overall
Outcome
38–41, 45,
47–58

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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136.

AFFIRMED