Cepheid

Patent Trials and Appeals Board

Mar 29, 2021

2019007015 (P.T.A.B. Mar. 29, 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.
14/019,267 09/05/2013 Ron Chang 085430-0969583-008710US 7339
172149 7590 03/29/2021
Cepheid / Kilpatrick Townsend & Stockton LLP
Mailstop: IP Docketing - 22
1100 Peachtree Street
Suite 2800
Atlanta, GA 30309
EXAMINER
WHATLEY, BENJAMIN R
ART UNIT PAPER NUMBER
1798
NOTIFICATION DATE DELIVERY MODE
03/29/2021 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):
Esther.Campbell@cepheid.com
IPlegal@cepheid.com
ipefiling@kilpatricktownsend.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte RON CHANG, STEVEN M. MONTGOMERY, and
GREGORY E. MOTE
__________

Appeal 2019-007015
Application 14/019,267
Technology Center 1700
____________

Before MICHAEL P. COLAIANNI, GEORGE C. BEST, and
DEBRA L. DENNETT, Administrative Patent Judges.

COLAIANNI, Administrative Patent Judge.

DECISION ON APPEAL

Appellant1 appeals under 35 U.S.C. § 134(a) the final rejections of
claims 21–41. We have jurisdiction over the appeal pursuant to 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 Cepheid
(Appeal Br. 3).
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STATEMENT OF THE CASE
Appellant’s invention is directed to a system and methods for
performing fluidic analytic sequences on fluid samples (Spec. 7:4–5).
According to the Specification, the system enables automatic identification
and authentication of ordered procedures as well as notification of
procedural state and other information (id. at 7:5–7). The described fluidic
analytic sequences may be performed in a modular housing, which contains
multiple chambers for receiving, containing, processing, and disposing of a
fluid sample (id. at 2:7–9; 2:29–3:2).
Claim 21 is illustrative (emphasis added):
21. A method for performing chemical and/or biological
sample testing, the method comprising:
receiving a sample cartridge containing a biological fluid
sample within a bay of a sample processing system through an
opening in a housing of the system having one or more
mechanisms within the bay configured to manipulate the
sample cartridge to perform sample testing of the biological
fluid sample while the biological sample is maintained within
the sample cartridge, the system having a door operable
between an open position to facilitate loading of the sample
cartridge and a closed position in which the door covers the
opening;
imaging an occupancy of the bay with an imaging device
incorporated in the door;
presenting, on an electronic display disposed on the
door, an indicator of a presence or an absence of the sample
cartridge within the bay so as to be viewable by a user when the
door is in the closed position; and
testing of the biological fluid sample while the biological
sample is maintained within the sample cartridge by
manipulation of the one or more mechanisms.
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Appellant appeals the following rejections:
1. Claims 21–37 and 39–41 are rejected under 35 U.S.C. § 112,
¶ 2 as indefinite (Final Act. 6–9).2
2. Claims 21–27, 29–34, and 37–40 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Cepheid GeneXpert systems YouTube
video (published online July 24, 2011,
https://www.youtube.com/watch?v=MlwPgV-O59s, “GeneXpert”), as
evidenced by “Xpert MTB/RIF – Two hour detection of MTB and
resistance to rifampicin” (published online May 15, 2009,
http://www.tbevidence.org/documents/rescentre/sop/XpertMTB_Broc
h_R9_EU.pdf, “Xpert MTB/RIF”), in view of Snider et al. (US
2011/0110180 A1; published May 12, 2011, “Snider”) (Final Act. 9–
18).
3. Claims 28, 35, and 36 are rejected under 35 U.S.C. § 103(a) as
unpatentable over GeneXpert, as evidenced by Xpert MTB/RIF, in
view of Snider, and further in view of Robinson et al. (US
2010/0291619 A1; published Nov. 18, 2010, “Robinson”) (Final Act.
19–20).
4. Claim 41 is rejected under 35 U.S.C. § 103(a) as unpatentable
over GeneXpert, as evidenced by Xpert MTB/RIF, in view of Snider,
and further in view of Handique et al. (US 2007/0292941 A1;
published Dec. 20, 2007, “Handique”) (Final Act. 20–21).

2 In the Answer, the Examiner has withdrawn the 35 U.S.C. § 112, ¶ 2
rejection of claim 38. Ans. 21.
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5. Claims 21, 22, 26, and 28–41 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Handique in view of Robinson (Final
Act. 21–23).
6. Claims 23–25 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Handique, in view of Robinson, and further in view
of Snider (Final Act. 23–24).
7. Claim 27 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Handique, in view of Robinson, and further in view of
GeneXpert, as evidenced by Xpert MTB/RIF (Final Act. 24–25).
Appellant offers separate arguments in support of independent claims
21 and 31 and dependent claims 28, 35, and 36 (see generally Appeal Br. 6–
16). Dependent claims 22–27, 29, 30, 32–34, and 37–41 will stand or fall
with our analysis of independent claims 21 and 31. Dependent claims 28,
35, and 36 will be discussed separately.
FINDINGS OF FACT & ANALYSIS
A. Rejection of claims 21–37 and 39–41 as indefinite under 35 U.S.C.
§ 112, ¶ 2
a. Claims 21 and 31
The Examiner determines that the limitation reciting “one or more
mechanisms . . . configured to manipulate the cartridge” is indefinite
because the “written description fails to disclose the corresponding structure,
material, or acts for performing the entire claimed function and to clearly
link the structure, material, or acts to the function” (Final Act. 7). According
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to the Examiner, Appellant fails to correlate the claimed mechanisms to any
specified structure in the Specification (id.).
Appellant argues that the claims are definite because one of ordinary
skill in the art would know what structures are configured to manipulate the
cartridge (Appeal Br. 6). Appellant contends that the Specification, which
incorporates by reference the disclosure of Dority et al. (US 8,048,386;
issued Nov. 1, 2011, “Dority”), entitled “Fluid Processing and Control,”
provides evidence of the ordinarily skilled artisan’s knowledge of such
structures (Reply Br. 2 (citing Spec. 4:2–5)).
In assessing whether a claim is indefinite, we determine whether those
skilled in the art would understand what is claimed when the claim is read in
light of the specification. Orthokinetics, Inc. v. Safety Travel Chairs, Inc.,
806 F.2d 1565, 1576 (Fed. Cir. 1986). In the present case, the Specification
describes that the claimed “mechanisms comprise activation of a rotary
valve to align ports through which material is moved within the sample
cartridge, and activation of a plunger that creates pressure alterations to urge
material to translate between chambers in a sample cartridge” (Spec. 4:2–5).
Contrary to the Examiner’s limited findings, the Specification’s description
of mechanisms for performing the claimed cartridge manipulation are not
limited to 9:5–27 and 14:11–23 (see Ans. 3). Rather, Appellant persuasively
argues that the written description incorporates by reference the disclosure
of Dority (Appeal Br. 6; Reply Br. 2; see Spec. 10:3–4 (“For further detail of
construction and operation of cartridge 200 in different exemplary
embodiments[,] please refer to the Dority patent”)). Based on our review,
Dority provides a detailed description of pneumatic pump mechanisms for
manipulating fluid sample cartridges (Dority 11:45–50; 13:10–24; 4:54–
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6:44; Figs. 4–8). In our view, one of ordinary skill in the art would
understand what is claimed when the claim is read in light of the
Specification, including the incorporated Dority reference.
b. Claim 21
Claim 21 requires “testing of the biological fluid sample while the
biological sample is maintained within the sample cartridge by manipulation
of the one or more mechanisms” (emphasis added).
The Examiner determines that “it is unclear what would or would not
define testing because applicants recite that testing of the cartridge is by
manipulation of the one or more mechanisms” (Final Act. 8). The Examiner
concludes that the claim is indefinite because biological testing typically
requires an analytical detector structure, but the Specification only describes
a valve, a port, an injection apparatus, a docking apparatus, a vacuum,
piston, and a plunger pump (Ans. 24 (citing Spec. 9:5–27; 14:11–23)).
According to the Examiner, “[i]t is unclear how any of the recited
mechanism structures would test the sample” without a detector structure
(Ans. 24).
As set forth above, the Specification incorporates by reference the
disclosure of Dority. Our review of Dority finds a detailed description of the
mechanisms used to provide conventional PCR testing of biological samples
in reaction vessels (Dority 8:10–9:24; 11:32–35). Dority further describes
the mechanisms used for the subsequent optical detection of PCR nucleic
acid products in an electrophoretic flow path (id. at 17–39–18:43; Fig. 24).
In our view, one of ordinary skill in the art would understand what is
claimed when the claim is read in light of the Specification, including the
incorporated Dority reference. See Orthokinetics, 806 F.2d at 1576.
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We note that the Examiner construes the disputed limitations under 35
U.S.C. § 112, ¶ 6 (Final Act. 7, 8). For the reasons set forth above, one of
ordinary skill in the art would recognize that the Specification and the
incorporated Dority reference expressly recite what structures, materials, or
acts perform the entire claimed functions. Therefore, claims 21 and 31
comport with the requirements of § 112, ¶ 6.
We reverse the Examiner’s § 112, second paragraph, rejection.
B. Rejection of claims 21–27, 29–34, and 37–40 as unpatentable over
GeneXpert, as evidenced by Xpert MTB/RIF, in view of Snider
a. Claim 21
The Examiner finds that GeneXpert’s method for performing
biological sample testing would have rendered obvious each component and
limitation of the method recited in independent claim 21, except that
GeneXpert fails to “specifically teach imaging an occupancy of the bay with
an imaging device incorporated in the door; and an electronic display
disposed on the door” (Final Act. 10).
The Examiner finds that Snider discloses the limitations missing from
GeneXpert (id.). The Examiner determines that it would have been obvious
for one of ordinary skill in the art at the time of the invention to configure
GeneXpert’s display and separate barcode scanner on the door as taught in
Snider because, inter alia, this location would have provided “the advantage
of obtaining information on the cartridge positioned within the housing . . .
and giving the user visual feedback (id. at 11; see Snider ¶ 27; Fig. 3).
Appellant argues that Snider’s automated beverage mixing device is
non-analogous art because it is not in the same field of endeavor and not
reasonably pertinent to Appellant’s problem (Appeal Br. 9–11; Reply Br. 5–
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8). With respect to whether Snider is reasonably pertinent, Appellant argues
that Snider does not address the same problem or serve the same purpose as
the imaging device and door display subject matter of claim 21 (Appeal Br.
17; Reply Br. 7). Appellant contends that the claimed subject matter
addresses the problem of large sample number testing, which requires
manual scanning of sample cartridges and/or entry of sample identification
and testing information (Ans. 8).
In response, the Examiner finds, inter alia, that Snider is reasonably
pertinent to the problem of using a sensor to automate cartridge
identification and attaining the benefits of placing a sensor and display on a
movable bay door (id. at 25). According to the Examiner, Snider is
analogous art because the relied upon reference “teaches an automated
system for cartridge processing within a housing” (id. at 25–26).
Prior art is considered analogous if it is either (1) from the same field
of endeavor, regardless of problem addressed, or (2) if not from the same
field of endeavor, the reference still is reasonably pertinent to the particular
problem with which the inventor was involved. In re Clay, 966 F.2d 656,
659 (Fed. Cir. 1992). “A reference is reasonably pertinent if it, as a result of
its subject matter, ‘logically would have commended itself to an inventor’s
attention in considering his problem.’” K-Tec, Inc. v. Vita-Mix Corp., 696
F.3d 1364, 1375 (Fed. Cir. 2012) (quoting Innovention Toys, LLC v. MGA
Entm’t, Inc., 637 F.3d 1314, 1321 (Fed. Cir. 2011)).
In this instance, Appellant’s analysis does not explain why Snider is
not reasonably pertinent to the problem faced by Appellant, namely
automating sample cartridge identification and attaining the benefits of
placing a sensor and display on a movable bay door. Snider shows how bay
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occupancy can be automated through an imaging device incorporated in the
door and how the occupancy status of the bay may be automatically
displayed to the user on an electronic display disposed on the door (Snider
¶ 27; Fig. 3). We find that Snider would have logically commended itself to
an inventor’s attention when considering how best to automate cartridge
processing within a housing, while providing the user visual feedback as to
housing occupancy. Accordingly, we find that Snider is reasonably
pertinent to Appellant’s problem, and thus is analogous art.
Therefore, Appellant’s arguments are insufficient to convince us of
reversible error in the Examiner’s rejection of claim 21. Appellant argues
claims 22–27, 29–34, and 37–40 as a group (Appeal Br. 8–11).
On this record, we sustain the Examiner’s § 103 rejection as to claims
21–27, 29–34, and 37–40.
C. Rejection of claims 28, 35, and 36 as unpatentable over
GeneXpert, as evidenced by Xpert MTB/RIF, in view of Snider, and
further in view of Robinson
The Examiner finds that GeneXpert, as modified by Snider, fails to
teach the limitations requiring a touch screen display. The Examiner relies
on Robinson for teaching that touch screen display 150 is on moving door
162, which opens and closes with respect to housing 102 (Final Act. 19).
Appellant argues that Robinson’s door 162 is not a door, but is
actually “an openable section of the housing” (Appeal Br. 12). Appellant
argues that door 162 is distinguished from the instant claims because the
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described housing section is “not for routine loading/unloading of a sample
cartridge into a bay” (id. at 13; Reply Br. 8).
Appellant’s argument is not persuasive.
We find that Robinson explicitly refers to component 162 as “an
operable door” (Robinson ¶ 160). We, furthermore, agree with the
Examiner that Appellant’s arguments improperly attack the references
individually instead of addressing what the combined teachings of the
applied prior art would have suggested (Ans. 26). See In re Keller, 642 F.2d
413, 426 (CCPA 1981). As the Examiner explains, Robinson is not relied
upon to teach the door providing access to a bay in which a sample cartridge
is received (Ans. 26). Rather, the Examiner relied upon GeneXpert for
teaching that a door may open for the insertion of the cartridge and close for
subsequent sample testing (id.). Therefore, we sustain the Examiner’s § 103
rejection as to claims 28, 35, and 36.
D. Rejection of claim 41 as unpatentable over GeneXpert, as
evidenced by Xpert MTB/RIF, in view of Snider, and further in
view of Handique
Appellant relies on the same unpersuasive arguments set forth above
regarding Snider in Ground 2 (see supra § B; Appeal Br. 8–11, 14).
Therefore, we sustain the Examiner’s § 103 rejection as to claim 41.
E. Rejection of claims 21, 22, 26, and 28–41 as unpatentable over
Handique in view of Robinson
Appellant relies on the same unpersuasive arguments set forth above
regarding Robinson in Ground 3 (see supra § C; Appeal Br. 15). Therefore,
we sustain the Examiner’s § 103 rejection as to claims 21, 22, 26, and 28–
41.
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F. Rejection of claims 23–25 as unpatentable over Handique, in view
of Robinson, and further in view of Snider
Appellant relies on the same unpersuasive arguments set forth above
regarding Robinson in Ground 5 (see supra §§ C, E; Appeal Br. 12–14, 15–
16). Therefore, we sustain the Examiner’s § 103 rejection as to claims 23–
25.
G. Rejection of claim 27 as unpatentable over Handique, in view of
Robinson, and further in view of GeneXpert, as evidenced by Xpert
MTB/RIF
Appellant relies on the same unpersuasive arguments set forth above
regarding Robinson in Grounds 5 and 6 (see supra §§ C, E, F; Appeal Br.
12–14, 15–16). Therefore, we sustain the Examiner’s § 103 rejection as to
claim 27.
CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
21–37, 39–
41
112, second
paragraph
Indefiniteness 21–37,
39–41
21–27, 29–
34, 37–40
103(a)

GeneXpert, Xpert
MTB/RIF, Snider
21–27, 29–
34, 37–40

28, 35, 36 103(a)

GeneXpert, Xpert
MTB/RIF, Snider,
Robinson
28, 35, 36
41 103(a)

GeneXpert, Xpert
MTB/RIF, Snider,
Handique
41
21, 22, 26,
28–41
103(a)

Handique,
Robinson

21, 22, 26,
28–41

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Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
23–25 103(a)

Handique,
Robinson, Snider
23–25
27 103(a)

Handique,
Robinson,
GeneXpert, Xpert
MTB/RIF
27
Overall
Outcome
21–41
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).
AFFIRMED