Theranos, Inc.

Patent Trials and Appeals Board

Nov 25, 2020

2020000078 (P.T.A.B. Nov. 25, 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.
14/598,625 01/16/2015 Elizabeth A. Holmes 2001.501A 1839
107075 7590 11/25/2020
Labrador Diagnostics LLC
160 Foss Creek Cir #2369
Healdsburg, CA 95448
EXAMINER
LIU, SHUYI S
ART UNIT PAPER NUMBER
1774
NOTIFICATION DATE DELIVERY MODE
11/25/2020 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 ELIZABETH A. HOLMES, DANIEL L. YOUNG,
TIMOTHY SMITH, SCOTT RIDEL, JOHN KENT FRANKOVICH,
and MICHAEL SIEGEL

Appeal 2020-000078
Application 14/598,625
Technology Center 1700
____________

Before TERRY J. OWENS, JEFFREY T. SMITH, and
MERRELL C. CASHION, JR., Administrative Patent Judges.

Opinion for the Board filed by Administrative Patent Judge SMITH.
Opinion Dissenting filed by Administrative Patent Judge OWENS.

SMITH, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 50–62 are pending in the application.2
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.
2 The claims on appeal appear in the corrected claims appendix submitted
July 1, 2019.
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Application 14/598,625

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STATEMENT OF THE CASE
Appellant’s invention is generally directed to a compact high speed
centrifuge for use with sample containers. (Spec. ¶ 5.) Independent claim
50 is representative of the appealed subject matter and is reproduced below:
50. A system comprising:
a centrifuge comprising:
a centrifuge body;
at least one sample vessel holder coupled to the centrifuge
body;
a drive mechanism for rotating said centrifuge body at a
rotational speed of at least 1000 rpm; and a detector for use in
determining at least a rotational position of the centrifuge body;
a centrifuge housing shaped to enclose at least a
circumferential perimeter of the centrifuge body;
a first air bearing configured to operably support an
underside surface of the centrifuge body, wherein at least a
portion of the first air bearing is defined by the centrifuge
housing; and
a second air bearing configured to operably support an
lateral surface of the centrifuge body, wherein at least a portion
of the second air bearing is defined by the centrifuge housing;
a fluid handling system comprising at least one pipette
head configured to provide overhead access to the centrifuge and
movable X-Y and Z directions; and
a programmable processor configured to align the at least
one pipette head of the fluid handling system with a holder.
Claims Appendix.
The following rejections are presented for our review: 3

3 The complete statement of the rejections on appeal appears in the April 10,
2018 Final Action. (Final Act. 6–11.)
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I. Claim 50 and 51 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Pang (US 7,141,213 B1, iss. Nov. 28, 2006) in view of
Krumme (US 2010/0034492 A1; pub. Feb. 11, 2010) and Ingber (US
2011/0008825 A1; pub. Jan 13, 2011).
II. Claim 52 is rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Pang, Krumme, Ingber and further in view of Noguchi
(US 7,667,184 B2; Feb 23. 2010).
III. Claims 53, 54, and 58 are rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination Pang, Krumme, Ingber and further in
view of Gordon (EP 1129783 A2; pub Sep. 5, 2001) and Meeks (US
2006/0013733 A1; Jan. 19, 2006).
IV. Claims 55–57 and 59–62 are rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Pang, Krumme, Ingber, and Ryu (US
2010/0009831 A1; pub. Jan. 14, 2010).
OPINION
We review the appealed rejections for error based upon the issues
Appellant identifies, and in light of the arguments and evidence produced
thereon. See In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (“[I]t has
long been the Board’s practice to require an applicant to identify the alleged
error in the examiner’s rejections” (citing Ex parte Frye, 94 USPQ2d 1072,
1075 (BPAI 2010) (precedential))).
Having considered the respective positions the Examiner and
Appellant advance in light of this appeal record, we affirm the Examiner’s
rejections based on the fact-finding and reasoning set forth in the Answer
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and Final Office Action, which we adopt as our own. We add the following
primarily for emphasis.

Rejection I
Claims 50 and 51 are rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Pang, Krumme, and Ingber.
We limit our discussion to the independent claim 50 as argued by
Appellant. (Appeal Br. 4–10).
Appellant argues Krumme fails to describe a housing that provides an
air bearing feature as required by independent claim 50. (Appeal Br. 4–6.)
Appellant argues Krumme instead uses pressurized gas at discrete structures
that are not part of the centrifuge housing to provide the air bearings.
(Appeal Br. 5 citing Krumme ¶ 36.)
Appellant’s arguments are not persuasive of reversible error for
reasons the Examiner presents. (Ans. 8–9.) Appellant has not refuted the
Examiner’s determination that Krumme’s axial air bearings 10, 11, and 12 as
well as Krumme’s radial air bearings 13, 14, and 15 are all structures
supported by or attached to the housing 2.4 (Final Act. 6–7; Krumme ¶ 18.)
Appellant has not established that Krumme’s attachment configuration is
patently distinct from the claimed invention. Appellant points to
Specification paragraphs 238, 245, and 246 and Figures 19–20 as descriptive
of the air bearings required by the claimed invention. (Appeal Br. 3.)
Specification paragraph 236 specifically discloses that air bearing 724 is
configured to opposite side walls of the centrifuge rotor. This description

4 Appellant has not refuted the Examiner's determination that Krumme stator
2 is a housing structure. (Final Act. 4.)
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does not require the air bearing to be an integral portion of the housing but
rather is inclusive of an attachment (configuration) to the housing. Thus,
Appellant has not directed us to evidence that establishes a patentable
distinction between an air bearing that is attached to the housing versus an
air bearing configured to the housing.
Appellant argues the Examiner relies on impermissible hindsight to
combine the teachings of the cited art. Appellant specifically state:
[T]hat ABSENT the impermissible use of HINDSIGHT, there
is NO technical benefit cited by the Examiner for making
the proposed combination of using a very SLOW 300 RPM
design of a CT scanner (Krumme) to “improve”" the
bearing function of a 3,600 to 100,000 RPM centrifuge
(Pang).
(Appeal Br. 7, emphasis original.)

We are unpersuaded by this argument. As the Examiner explains in
the Answer, one of ordinary skill in the art would have been capable of
applying Krumme’s teaching of a known method of enhancement to a
“base” device to Pang’s centrifuge with the expectation that the modified
device would be suitable to perform Pang’s centrifuging operation. Ans.
10–11. Therefore, the Examiner has provided a reasonable basis for
combining the teachings of the cited art.
Further, Appellant has not directed us to evidence that air bearings
were recognized to be unsuitable for operation at high speeds. The prior art
cited by the Examiner establishes that bearing functions can be achieved
utilizing air bearings as an alternative to mechanical bearings. (See Krumme
¶ 5.) A person of ordinary skill in the art would have recognized the suitable
adjustments that would have been necessary for operating air bearings
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dependent upon the speed of rotation. See KSR Int’l. Co. v. Teleflex Inc.,
550 U.S. 398, 418 (2007) (In making an obviousness determination one “can
take account of the inferences and creative steps that a person of ordinary
skill in the art would employ”).
Appellant further argues the Examiner has failed to establish a
reasonable expectation of success for utilizing Krumme’s bearings
configured for a vertical device given the horizontal configuration ascribed
by Pang. (Appeal Br. 9–11.)
Appellant’s arguments lack persuasive merit. It is not necessary to
physically incorporate the air bearings described by Krumme into the device
described by Pang to render obvious the claimed invention. See In re Etter,
756 F.2d 852, 859 (Fed. Cir. 1985) (en banc) (“Etter’s assertions that Azure
cannot be incorporated in Ambrosio are basically irrelevant, the criterion
being not whether the references could be physically combined but whether
the claimed inventions are rendered obvious by the teachings of the prior art
as a whole.”); see also In re Sneed, 710 F.2d 1544, 1550 (Fed. Cir. 1983)
(“[I]t is not necessary that the inventions of the references be physically
combinable to render obvious the invention under review.”) and In re
Nievelt, 482 F.2d 965, 968 (CCPA 1973) (“Combining the teachings of
references does not involve an ability to combine their specific structures.”).
“The test for obviousness is not whether the features of a secondary
reference may be bodily incorporated into the structure of the primary
reference.... Rather, the test is what the combined teachings of those
references would have suggested to those of ordinary skill in the art.” In re
Keller, 642 F.2d 413, 425 (CCPA 1981).
Appellant has not directed us to evidence that air bearings were
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recognized to be unsuitable for use at various angles. Given that Krumme
establishes that bearing functions can be achieved utilizing air bearings as an
alternative to mechanical bearings (see Krumme ¶ 5), Appellant has not
explained adequately why one skilled in the art would not have been capable
of adjusting Krumme’s air bearings to perform at a desired angle of
operation. See KSR. 550 U.S. at 418.
For the foregoing reasons and those the Examiner presents, we sustain
the rejection of claim 50.

Rejections II–IV
Claims 52–62 are rejected under 35 U.S.C. § 103(a) as unpatentable
over Pang, Krumme and Ingber in combination with additional references
stated in the rejections.
Appellant relies on the arguments presented for claim 50 to address
the rejections of claims 52–62. (Appeal Br. 11–12.) Appellant does not
assert non-obviousness based on the additional features set forth in claims
52–62 by explaining how the additional references cited by the Examiner
fail to establish the obviousness of these additional features. Because we do
not find Appellant’s arguments persuasive as to independent claim 50, it
follows that these arguments are unpersuasive as to claims 52–62.
CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
50, 51 103(a) Pang, Krumme,
Ingber
50, 51
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Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
52 103(a) Pang, Krumme,
Ingber, Noguchi
52
53, 54, 58 103(a) Pang, Krumme,
Ingber, Gordon,
Meeks
53, 54, 58
55–57, 59–62 103(a) Pang, Krumme,
Ingber, Ryu
55–57,
59–62

Overall
Outcome
50–62

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
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OWENS, Administrative Patent Judge, dissenting.
Setting forth a prima facie case of obviousness requires establishing
that the applied prior art would have provided one of ordinary skill in the art
with an apparent reason to modify the prior art to arrive at the claimed
invention. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
Pang discloses a laboratory centrifuge of the type having a spindle
driven at a speed as high as about 3,600 to about 100,000 rpm (col. 2, ll. 9–
18; col. 5, ll. 26–30). Pang is silent regarding centrifuge bearings.
Krumme discloses a computer tomograph (CT scanner) (¶ 3).
Krumme teaches (¶ 5):
In modem computer tomographs of high resolution, the rotating
part of the gantry rotates at high rotation numbers, for example
300 r.p.m. Simultaneously a very high positional tolerance of
the gantry in ranges distinctly below 1 mm is required. With
this, mechanical bearings frequently approach limits of what is
technologically possible. Here, an elegant way of providing a
bearing function is by means of an aerodynamic bearing, also
known as an air bearing.
Krumme’s CT scanner comprises “a rotatable device having aerostatic
bearing facilities and a direct drive in the form of a segmented ring motor so
that it can be equipped with a simpler and thus also less costly bearing
means” (¶ 8).
The Examiner finds (Ans. 10):
[O]ne of ordinary skill in the art would be well aware that what
would be considered a "high" rotational speed for a larger
rotational device, such as the gantry of a CT scanner, would not
necessarily be considered a "high" rotational speed for a smaller
rotational device, since the RPM of a rotational device is a
function of the radius of the rotor. Given such understanding,
however, one of ordinary skill in the art would still be able to
glean from the teachings of Krumme that air bearings can
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provide improved bearing performance at high rotational speeds
for a rotatable device of any give size, including a centrifuge of
any size. The rationale to support a conclusion that the claim
would have been obvious is that a method of enhancing a
particular class of devices (methods, or products) has been
made part of the ordinary capabilities of one skilled in the art
based upon the teaching of such improvement in other
situations. One of ordinary skill in the art would have been
capable of applying this known method of enhancement to a
"base" device (method, or product) in the prior art and the
results would have been predictable to one of ordinary skill in
the art.

The Examiner concludes that [i]t would have been obvious for one having
ordinary skill in the art at the time of the invention to have provided the
system of Pang et al. with the air bearings of Krumme for the purpose of
providing improved bearing function for a rotatable device at high rotation
numbers (paragraph [0003], [0005], [0023]) (Final Rej. 7).
The Examiner does not provide evidence supporting the finding that
“one of ordinary skill in the art would still be able to glean from the
teachings of Krumme that air bearings can provide improved bearing
performance at high rotational speeds for a rotatable device of any give size,
including a centrifuge of any size.” See In re Warner, 379 F.2d 1011, 1017
(CCPA 1967) (“A rejection based on section 103 clearly must rest on a
factual basis, and these facts must be interpreted without hindsight
reconstruction of the invention from the prior art”). Also, the Examiner’s
finding that one of ordinary skill in the art would have been capable of
making the proposed modification to Pang’s centrifuge does not establish
that Krumme would have provided one of ordinary skill in the art with an
apparent reason to make that modification.
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Accordingly, I dissent from the affirmance of the Examiner’s
rejection.