Ex Parte Regan et al

Patent Trial and Appeal Board

Jul 16, 2013

12712345 (P.T.A.B. Jul. 16, 2013)

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.
12/712,345 02/25/2010 John Frederick Regan IL-11738B 2505
24981 7590 07/17/2013
Lawrence Livermore National Security, LLC
LAWRENCE LIVERMORE NATIONAL LABORATORY
PO BOX 808, L-703
LIVERMORE, CA 94551-0808
EXAMINER
HURST, JONATHAN M
ART UNIT PAPER NUMBER
1775
MAIL DATE DELIVERY MODE
07/17/2013 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

Ex parte JOHN FREDERICK REGAN and
JAMES MICHAEL BIRCH
________________

Appeal 2012-002544
Application 12/712,345
Technology Center 1700
________________

Before TERRY J. OWENS, CATHERINE Q. TIMM, and
JAMES C. HOUSEL, Administrative Patent Judges.

OWENS, Administrative Patent Judge.

DECISION ON APPEAL

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Application 12/712,345

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STATEMENT OF THE CASE
The Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s
rejection of claims 1-7, which are all of the pending claims. We have
jurisdiction under 35 U.S.C. § 6(b).
The Invention
The Appellants claim a method for disease diagnosis. Claim 1 is
illustrative:
1. A computer implemented method of diagnosing
diseases at hospitals, staffed pharmacies or unstaffed locations
for analyzing a vial containing a specimen sample from a user,
comprising the steps of:
providing an automated diagnostic vending machine,
providing a computer in said automated diagnostic
vending machine,
providing a diagnostic unit in said automated diagnostic
vending machine operably connected to said computer,
providing an automated genetic assay diagnostic
instrument in said diagnostic unit in said automated diagnostic
vending machine that performs nucleic acid extraction from
the specimen and produces a genetic assay from the specimen
and produces a disease diagnoses,
providing a unit for communicating said disease
diagnoses to the users in said automated diagnostic vending
machine operably connected to said computer and to said
diagnostic vending machine unit,
positioning said diagnostic vending machine at the
hospitals, the staffed pharmacies or the unstaffed locations,
delivering the vial to said automated diagnostic vending
machine,
using said automated diagnostic vending machine for
sample acquisition and processing to perform said nucleic acid
extraction from the specimen and produce said genetic assay
from the specimen and to produce said disease diagnosis,
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Application 12/712,345

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using said automated diagnostic vending machine for
diagnosing diseases from the specimen sample providing said
disease diagnosis, and
using said unit for communicating said disease diagnoses
to the users in said automated diagnostic vending machine for
communicating said disease diagnosis to the user.

The References
Ammann US 6,335,166 B1 Jan. 1, 2002
Devlin US 2002/0064881 A1 May 30, 2002
Bulat US 6,638,218 B2 Oct. 28, 2003
Squilla US 2006/0111620 A1 May 25, 2006
The Rejections
The claims stand rejected under 35 U.S.C. § 103 as follows: claims 1-
3 over Squilla in view of Ammann, claims 4-6 over Squilla in view of
Ammann and Devlin and claim 7 over Squilla in view of Ammann, Devlin
and Bulat.
OPINION
The rejections are affirmed as to claims 1, 2 and 4-7 and reversed as
to claim 3.
In most of the Appellants’ arguments in the Brief and the Reply Brief
the Appellants improperly address each reference individually and argue that
the reference does not disclose or suggest claim requirements for which the
reference is not relied upon by the Examiner. See In re Merck & Co., 800
F.2d 1091, 1097 (Fed. Cir. 1986) (“Non-obviousness cannot be established
by attacking references individually where the rejection is based upon the
teachings of a combination of references”). We address only the Appellants’
arguments directed toward the references relied upon by the Examiner to
meet the Appellants’ argued claim limitations.
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Rejection of claims 1-3 over Squilla in view of Ammann
Squilla discloses a medical kiosk at which an unassisted customer can
obtain a disease diagnosis using a medical test which can be a saliva test or a
hair sample DNA test and can receive the results of the diagnosis
(¶¶ 0006, 0009, 0015, 0041, 0048, 0056, 0080, 0111, 0113).
Ammann discloses an automated, computer-controlled, self-contained,
stand-alone diagnostic analyzer which can carry out nucleic acid-based
assays and preferably stores specimens, reaction receptacles, materials used
in performing the assays, and assay waste products (col. 4, ll. 17-48; col. 24,
l. 52 – col. 25, l. 2). Ammann teaches that the uses for diagnostic assays
include determine disease states (col. 1, ll. 16-21).
Claims 1 and 2
The Appellants argue that Ammann does not produce a genetic assay
and a disease diagnosis (Br. 22-23; Reply Br. 2).
Ammann produces a genetic assay (col. 4, ll. 17-34) and indicates that
it can provide a disease diagnosis (col. 1, ll. 9-21). Thus, in view of
Squilla’s disclosures that the uses of Squilla’s medical kiosk are not limited
and include providing DNA information (¶¶ 0009, 0041, 0077-83, 0113),
one of ordinary skill in the art, through no more than ordinary creativity,
would have been led by Squilla to configure Ammann’s analyzer as a
medical kiosk so that an unassisted customer can carry out and obtain the
results of a genetic assay for disease diagnosis. 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”).
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The Appellants argue that Squilla does not communicate disease
diagnoses to users (Reply Br. 4).
Squilla communicates to consumer’s analysis results which would
include the disease diagnosis discussed above (¶¶ 0015, 0048, 0055-59).
The Appellants argue regarding claim 2 that Ammann does not
disclose sample acquisition needles (Br. 24).
Ammann’s indication that genetic assays can be carried out on blood
samples (col. 2, ll. 8-13) would have led one of ordinary skill in the art,
through no more than ordinary creativity, to include, among the materials
used to perform the analysis which are stored in the analyzer (col. 4, ll. 39-
43, needles for taking blood samples. See KSR, 550 U.S. at 418.
Thus, we are not persuaded of reversible error in the rejection of
claims 1 and 2.
Claim 3
The Appellants argue regarding claim 3 that Ammann does not
disclose sample lines (Br. 24-25).
The Examiner argues that the use of multiple sample lines in
Ammann’s analyzer would be a mere duplication of parts and would reduce
the amount of time required to perform a number of tests (Ans. 7-8, 24).
The Examiner has not pointed out where Squilla or Ammann discloses
any sample line or explained why those references would have fairly
suggested a sample line to one of ordinary skill in the art.
The Examiner, therefore, has not established a prima facie case of
obviousness of the method claimed in the Appellants’ claim 3.

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Rejection of claims 4-6 over Squilla
in view of Ammann and Devlin
Devlin discloses an automated clinical analyzer wherein, after an
aliquot of a patient’s specimen has been tested, another aliquot of the
specimen is retained for a period of time to enable a second test of the
specimen (abstract; ¶¶ 0019, 0038-39).
The Appellants argue that Devlin does not disclose supporting the
archived aliquots on a tray (Br. 33-34).
Devlin’s disclosure of supporting the aliquot storage vessel (43) on
shelves, clips or other similar storage vessel receptacles (¶ 0038) would have
led one of ordinary skill in the art, through no more than ordinary creativity,
to use a support device similar to a shelf such as a tray. See KSR, 550 U.S.
at 418.
The Appellants argue that Devlin does not disclose claim 1’s
requirements which the Appellants argue are lacking from Squilla and
Ammann (Br. 32-33; Reply Br. 9-10).
As set forth above regarding the rejection of claim 1, those claim
requirements would have been rendered prima facie obvious to one of
ordinary skill in the art by the combined disclosures of Squilla and Ammann.
Rejection of claim 7 over Squilla in view of
Ammann, Devlin and Bulat
Bulat discloses a medical kiosk which includes a credit card reader for
payment of physician services (col. 14, ll. 36-37, 53-56).
The Appellants assert that the applied references lack the claim 7
requirements, but the Appellants provide no substantive supporting
argument (Br. 42-43).
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The Appellants argue that Bulat does not disclose claim 1’s
requirements which the Appellants argue are lacking from Squilla and
Ammann (Reply Br. 12).
As explained above regarding the rejection of claim 1, those claim
requirements would have been rendered prima facie obvious to one of
ordinary skill in the art by the combined disclosures of Squilla and Ammann.
For the above reasons we are not persuaded of reversible error in the
rejections of claims 1, 2 and 4-7.
DECISION/ORDER
The rejection under 35 U.S.C. § 103 of claims 1-3 over Squilla in
view of Ammann is affirmed as to claims 1 and 2 and reversed as to claim 3.
The rejection under 35 U.S.C. § 103 of claims 4-6 over Squilla in view of
Ammann and Devlin and claim 7 over Squilla in view of Ammann, Devlin
and Bulat are affirmed.
It is ordered that the Examiner’s decision is affirmed-in-part.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED-IN-PART

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