Theranos, Inc.

Patent Trials and Appeals Board

Oct 16, 2020

15042909 - (D) (P.T.A.B. Oct. 16, 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.
15/042,909 02/12/2016 Clarissa Lui 3024.202 5279
107075 7590 10/16/2020
Labrador Diagnostics LLC
160 Foss Creek Cir #2369
Healdsburg, CA 95448
EXAMINER
SIEFKE, SAMUEL P
ART UNIT PAPER NUMBER
1797
NOTIFICATION DATE DELIVERY MODE
10/16/2020 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):
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 CLARISSA LUI and ELIZABETH A. HOLMES
Appeal 2019-006751
Application 15/042,909
Technology Center 1700
Before TERRY J. OWENS, BEVERLY A. FRANKLIN, and
JAMES C. HOUSEL, Administrative Patent Judges.
OWENS, 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 101–112 and 114–131. 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 the real party in interest as Theranos IP
Company, Inc. (Appeal Br. 2).
Appeal 2019-006751
Application 15/042,909

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CLAIMED SUBJECT MATTER
The claims are directed to a system for receiving a swab. Claim 101,
reproduced below, is illustrative of the claimed subject matter:
101. A system comprising:
a sample analysis device; and
a cartridge comprising a swab container assembly
comprising a swab container, a swab entry port, an assay chamber
having an upper port and a lower port, and a conduit coupled to the
swab entry port and the assay chamber, effective that passing a
swab through said entry port and through the conduit allows at
least a portion of said swab to be placed within said assay chamber
through the lower port of the assay chamber without passing the
swab through the upper port of the assay chamber
said cartridge further comprising:
a cartridge frame configured for insertion into said sample
analysis device, said cartridge frame comprising a plurality of
receptacles, wherein said receptacles comprise:
a sample receptacle configured to receive a sample
collection vessel for holding a non-swab, fluid sample; and
a plurality of implement receptacles configured to receive
implements for use by said sample analysis device.
REFERENCES
The references relied upon by the Examiner are:
Name Reference Date
Carrera Fabra US 2013/0244241 A1 Sept. 19, 2013
Lui US 9,302,264 B2 Apr. 5, 2016
REJECTIONS
Claims 101–112 and 114–131 stand rejected as follows: 1) under
35 U.S.C. § 102(a)(1) over Carrera Fabra; 2) under 35 U.S.C. § 112(a) as
failing to comply with the written description requirement; and 3) on the
Appeal 2019-006751
Application 15/042,909

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ground of nonstatutory obviousness-type double patenting over claims 1–29
of Lui.
OPINION
Rejection under 35 U.S.C. § 102(a)(1)
We need address only the sole independent claim, i.e., claim 101.
“Anticipation requires that every limitation of the claim in issue be
disclosed, either expressly or under principles of inherency, in a single prior
art reference.” Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868
F.2d 1251, 1255–56 (Fed. Cir. 1989).
Carrera Fabra discloses in Figures 5A and 5B a test cartridge
system (500) comprising a housing (502) containing a sample port (514)
leading into a swab receptacle chamber (524b), and an opening (515)
leading into an inner processing chamber (not numbered) (¶¶ 83–85).
Figures 6A and 6B disclose side views of the housing (500) which show that
it contains a premixing chamber (631) leading to reaction chambers (616)
(¶¶ 86, 91).
The Examiner draws boundaries around regions in Carrera Fabra’s
Figures 6A and 6B and labels portions of those regions as a swab entry port,
a conduit, an assay chamber, an upper port, and a lower port (Ans. 5). The
Examiner does not establish that Carrera Fabra identifies any component in
Figures 6A or 6B as a swab entry port, a conduit, or an assay chamber
having upper and lower ports, and the labeled assay chamber does not
include the labeled upper port or the labeled lower port.
“‘[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification.’” In re
Appeal 2019-006751
Application 15/042,909

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Translogic Tech. Inc., 504 F.3d 1249, 1256 (Fed. Cir. 2007) (quoting In re
Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000)).
The Examiner does not address the Appellant’s Specification and
establish that the broadest reasonable interpretation of the Appellant’s claim
term “assay chamber having an upper port and a lower port” in view thereof
includes the region within the boundary the Examiner labeled “assay
chambers” in Carrera Fabra’s Figures 6A and 6B that excludes the regions
the Examiner labeled “upper port” and “lower port.”
The Examiner, therefore has not established that Carrera Fabra
discloses each of the Appellant’s claim limitations. Accordingly, we reverse
the rejection under 35 U.S.C. § 102(a)(1).
Rejection under 35 U.S.C. § 112(a) and nonstatutory
obviousness-type double patenting rejection

The Appellant does not challenge the rejection under
35 U.S.C. § 112(a) or the nonstatutory obviousness-type double patenting
rejection (Appeal Br. 3). We therefore summarily affirm those rejections.
CONCLUSION
The Examiner’s decision to reject claims 101–112 and 114–131 is
affirmed.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
101–112,
114–131
102(a)(1) Carrera Fabra 101–112,
114–131
101–112,
114–131
112(a) Written description 101–112,
114–131

Appeal 2019-006751
Application 15/042,909

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101–112,
114–131
Nonstatutory Obviousness-type
double patenting
101–112,
114–131

Overall
Outcome
101–112,
114–131

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).
AFFIRMED