Ex Parte Chen

Patent Trial and Appeal Board

Dec 20, 2016

13388814 (P.T.A.B. Dec. 20, 2016)

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.
13/388,814 02/03/2012 Gong Chen CFLAY.40638US 5247
110933 7590
Carstens & Cahoon, LLP
PO Box 802334
Dallas, TX 75380
12/20/2016 EXAMINER
SAVAGE, MATTHEW O
ART UNIT PAPER NUMBER
1773
MAIL DATE DELIVERY MODE
12/20/2016 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 GONG CHEN
Appeal 2015-005805
Application 13/388,814
Technology Center 1700
Before LINDA M. GAUDETTE, ELIZABETH M. ROESEL, and
AVELYN M. ROSS, Administrative Patent Judges.
ROESEL, Administrative Patent Judge.
DECISION ON APPEAL
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision rejecting claims 23, 25, 27—35, and 37—39. We have jurisdiction
under 35 U.S.C. § 6(b).2
We AFFIRM.
1 Frito-Lay Trading Company GmbH is identified as the real party in
interest. App. Br. 3.
2 In our opinion below, we reference the Specification filed February 3, 2012
(Spec.), Final Office Action mailed August 20, 2014 (Final Action), the
Appeal Brief filed November 19, 2014 and corrected Claims Appendix filed
December 30, 2014 (App. Br.), the Examiner’s Answer mailed March 18,
2015 (Ans.), and the Reply Brief filed May 18, 2015 (Reply Br.).
Appeal 2015-005805
Application 13/388,814
STATEMENT OF THE CASE
Claimed Invention
Appellant claims an automated method of preparing an aqueous
sample for use in an analytical process and a cartridge for use in such a
method. App. Br. 28, 31 (claims 23 and 33); Spec. 11. The method is
useful for preparing samples derived from foodstuffs, the sample being for
use in an analytical process for quantitatively determining the amount of
acrylamide in the sample. App. Br. 32 (claim 35); Spec. 11.
Claims 23 and 33 are illustrative of the subject matter on appeal and
are reproduced below from Appellants’ Claims Appendix:
23. An automated method of preparing an aqueous
sample for use in an analytical process, the sample including at
least one water-soluble analyte derived from a foodstuff, the
automated method comprising the steps of:
(a) providing a solid-phase extraction cartridge
complising first and second sorbent materials arranged to
absorb thereon different respective chemical components, the
cartridge comprising a chamber containing the first and second
sorbent materials and having an inlet and an outlet, wherein the
first and second sorbent materials are arranged as a stack of two
layers within the cartridge, the first sorbent material is disposed
as an upper layer on an inlet side of the cartridge and comprises
a water-wettable reversed phase polymeric sorbent material
which is adapted to absorb thereon hydrophobic organic
molecules and the second sorbent material is disposed as a
lower layer on an outlet side of the cartridge and comprises a
mixed-mode silica based sorbent material which is adapted to
absorb thereon anionic and cationic components;
(b) conditioning the first and second absorbents by
flowing a conditioning fluid through the cartridge from inlet to
outlet;
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Application 13/388,814
(c) flowing through the inlet an aqueous sample
comprising at least one water-soluble analyte derived from a
foodstuff and impurities, thereby to disperse the sample within
at least one of the first and second sorbent materials;
(d) flowing through the inlet a washing liquid so as at
least partially to separate the at least one water-soluble analyte
and the impurities within the first and second sorbent materials;
and
(e) eluting the at least one water-soluble analyte from the
outlet of the cartridge by flowing an elution liquid into the inlet;
wherein the conditioning of step (b), the flowing of steps
(c) and (d), and the eluting of step (e) are carried out under
positive fluid pressure from a liquid injection device and at a
controlled flow rate such that all these steps are completed in
less than 10 minutes.
33. A solid-phase extraction cartridge for preparing a
sample to detect acrylamide, the cartridge comprising first and
second layers of sorbent materials arranged to absorb thereon
different respective chemical components of the sample, the
cartridge comprising a chamber containing the first and second
layers of sorbent materials and having an inlet and an outlet, the
first and second sorbent layers being arranged as a vertical stack
within the cartridge, the first sorbent layer being disposed as an
upper layer on an inlet side of the cartridge and comprising a
water-wettable reversed phase polymeric sorbent material
which is adapted to retain hydrophobic organic molecules, and
the second sorbent layer being disposed vertically below the
first layer as a lower layer on an outlet side of the cartridge and
comprising a mixed-mode silica-based sorbent material which
is adapted to retain anionic and cationic components, the
cartridge inlet adapted for receiving liquid under positive
pressure from a liquid injection device,
wherein the first and second sorbent layers each
comprising a packed body of particulate materials selected to
permit conditioning of the sorbents in the cartridge and
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Application 13/388,814
subsequent completion of extraction and elution, all in less than
10 minutes.
App. Br. 28—29, 31.
Evidence
The Examiner relies on the following references:
Ricker, U.S. Patent Publication 2006/0083663 Al, published April 20,
2006 (“Ricker”); and
H. Wang et al., SPE/HPLC/UVStudies on Acrylamide in Deep-fried
Flour-based Indigenous Chinese Foods, 89 Microchemical Journal 90—97
(2008) (“Wang”).
Appellant’s Evidence Appendix includes a copy of the following:
U.S. Food and Drug Administration, Detection and Quantification of
Acrylamide in Foods, published as a draft on June 20, 2002, updated July 23,
2002 and February 24, 2003, available at
http:// www.fda. gov/Food/F oodbornelllnessContaminants/ChemicalContami
nants/ucm053537.htm (printed on 11/19/2014) (“FDA Report”).
Rejections
The Examiner maintains the following rejections:
I. Claims 23, 25, and 27—32 under 35 U.S.C. § 112, second paragraph
as indefinite. Final Action 2.
2. Claims 23, 25, 27—35, and 37—39 under 35 U.S.C. § 103(a) as
unpatentable over Ricker in view of Wang. Id. at 3—14.
ANAFYSIS
Indefiniteness
The Examiner rejects claim 23 and its dependent claims for
indefiniteness. According to the Examiner, it is unclear whether the method
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Application 13/388,814
is “automated,” as recited in the preamble of claim 23, since no automation
steps are positively recited in the body of the claim. Final Action 2; Ans. 16.
Appellant argues there is no requirement to recite words like
“automatically” in the body of the claim. App. Br. 10. Appellant
additionally argues that the preamble is a mere statement of intended
purpose and is not entitled to patentable weight. Reply Br. 2.
Generally, a claim preamble is not limiting. Summit 6, LLC v.
Samsung Elecs. Co., 802 F.3d 1283, 1292 (Fed. Cir. 2015). A preamble
limits the scope of a claim, if it recites essential structure or steps or is
necessary to give life, meaning, and vitality to the claim. TomTom, Inc. v.
Michael Adolph, 790 F.3d 1315, 1323 (Fed. Cir. 2015); Catalina Mktg. Int'l,
Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002).
Conversely, a preamble is not limiting where the claim body defines a
structurally complete invention and the preamble only states a purpose or
intended use for the invention. TomTom, 790 F.3d at 1323; Catalina, 289
F.3d at 808. A patent should be reviewed in its entirety to determine
whether preamble language represents an additional structural limitation or
mere introductory language. In re Paulsen, 30 F.3d 1475, 1479 (Fed. Cir.
1994).
We agree with Appellant that the term, “automated,” in the preamble
of claim 23 is mere introductory language that states a purpose or intended
use for the method. Reply Br. 2. As noted by the Examiner and not
disputed by Appellant, no automation steps are recited in the body of claim
23. Final Action 2; Ans. 16. Neither Appellant nor the Examiner directs us
to disclosure in the Specification limiting the scope of the invention to
automated methods. In this regard, we note that claim 32 depends from and
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Application 13/388,814
further limits claim 23 by reciting an additional step that is performed
automatically. App. Br. 30. We also note that paragraph 24 of the
Specification states that “typically” transfer of the sample occurs
automatically, thus implying that automation is not a requirement of the
invention. Spec. 124. Accordingly, we determine that the term
“automated,” in the preamble of claim 23 is not necessary to give life,
meaning, and vitality to the claim.
Because the term, “automated,” in the preamble of claim 23 is not a
limitation of the claim, there is no ambiguity. The claim encompasses
methods that are automated, as well as methods that are not automated. See
In re Gardner, 427 F.2d 786, 788 (CCPA 1970) (“[bjreadth is not
indefiniteness”).
Obviousness
The Appeal Brief divides the appealed claims into four groups and
presents arguments under a separate heading for each group; however,
Appellant presents essentially the same arguments for each claim group,
focusing on a limitation that is common to all claims (“less than 10
minutes”). App. Br. 9, 12—26. Accordingly, claims 23, 25, 27—35, and 37—
39 stand or fall together, and we select claim 23 as representative for
deciding the issues raised by Appellant’s arguments. These issues are: (1)
whether the Examiner errs in finding that a person of ordinary skill in the art
would have combined the teachings of Ricker and Wang, notwithstanding
the teachings of the FDA Report; and (2) whether the Examiner errs in
finding that the combination of Ricker and Wang teaches or suggests a
method that could have been optimized to meet the time limitation of claim
23 (“less than 10 minutes”). We address each of these issues below.
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FDA Report and Teaching Away
The Examiner finds that Ricker discloses an automated method of
using solid phase extraction (SPE) to prepare an aqueous sample for use in
an analytical process and discloses most of the limitations of claim 23. Final
Action 3^4. The Examiner finds that Wang discloses an analogous solid
phase extraction process and teaches limitations that are missing from
Ricker, including first and second sorbent materials, as recited in claim 23.
Id. at 4. The Examiner concludes that it would have been obvious to have
modified the method of Ricker to include first and second sorbents as taught
by Wang “in order to provide an arrangement that was simple, capable of
providing fast processing rates, that was inexpensive, and capable of
providing high recoveries [of] acrylamide from an aqueous sample derived
from a foodstuff.” Id. at 4—5.
Appellant argues that a person of ordinary skill in the art would not
have combined the teachings of Ricker and Wang because Wang discloses a
manual process that quite closely follows the procedure of the FDA Report,
which Appellant contends teaches against speeding up the process and using
forced liquid injection, as in Ricker. Id. at 12—15. According to Appellant,
the Examiner failed to give adequate weight to the FDA Report. Id. at 16,
19,21; see also Reply Br. 5—8 (discussing Wang, the FDA Report, and
teaching away).
We are not persuaded that Appellant identifies reversible error in the
Examiner’s finding that a person of ordinary skill in the art would have
combined the teachings of Ricker and Wang in the manner proposed in the
Final Action. Final Action 4—5. For the reasons discussed below, the
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Examiner’s finding is supported by the teachings of Ricker and Wang and is
not inconsistent with the FDA Report.
Appellant does not dispute the Examiner’s finding that both Ricker
and Wang disclose a sample cleanup process in which solid phase extraction
(SPE) is used to prepare an aqueous sample for analysis via, e.g., high
pressure liquid chromatography (HPLC). Final Action 5; Ricker || 2—\\
Wang Abstract, 92 (sections 2.2 and 3.1). Appellant is correct that Ricker’s
process is automated, while Wang’s process is largely manual and similar to
the procedure of the FDA Report. App. Br. 12, 14. We are not, however,
persuaded that the FDA Report teaches against automating Wang’s process,
or more specifically, using the sorbents and foodstuff sample disclosed in
Wang in an automated process such as disclosed in Ricker.
Ricker supports the Examiner’s finding by teaching the desirability of
automating sample preparation processes, including those that have been
performed manually. Ricker H 4, 12. Ricker identifies a number of
advantages of automation, including reproducible sample preparation
conditions, eliminating backpressure variations, and precise timing between
sample preparation and chromatographic analysis. Id. ]f 12. Wang also
supports the Examiner’s finding by emphasizing the importance of providing
a simple, fast, and inexpensive method for determining acrylamide levels in
food. Wang Abstract, 91 (second column).
In addition, Ricker supports the Examiner’s finding that a person of
ordinary skill in the art would have modified the method of Ricker to include
the sorbents as taught by Wang. More specifically, Ricker teaches the use of
solid phase extraction (SPE) media, including sorbents such as porous silica
and porous particles based on organic polymer. Ricker 125. Ricker’s
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disclosure is broad enough to encompass the SPE media taught by Wang.
Wang 91—92 (sections 2.1 and 2.2 disclosing Oasis HLB and Bond Elut-
Accucat SPE sorbents). Furthermore, as noted by the Examiner, both Ricker
and Wang teach the use of two SPE media connected in series. Ans. 17;
Ricker || 25, 45, Fig. 7B (showing two distinct stationary phase materials
22A, 22B in a stacked arrangement in cartridge 2C); Wang 92 (section 3.1:
“Our approach was to combine Oasis HLB and Bond Elut-Accucat
cartridges. Samples were directly passed through the two SPE cartridges
and all elutant was collected . . . .”).
Appellant directs us to the FDA Report and its teaching: “Do not use
a vacuum to speed up the elution process in any of the SPE steps.” FDA
Report 3,1 8; App. Br. 14 (quoting Spec. 1 8). We are not persuaded that
this teaching outweighs the evidence cited by the Examiner and outlined
above supporting that a person of ordinary skill in the art would have
combined Wang’s sorbents and foodstuff sample with Ricker’s automated
method. Final Action 4—5; Ans. 17. The FDA Report cautions against the
use of a vacuum, but does not prohibit other ways of speeding up the elution
process, such as Ricker’s forced liquid injection method. Ricker 127, Figs.
3 A—3C (discussing and illustrating forced injection of liquid sample through
needle 6A into chamber containing stationary phase, e.g., SPE media). Nor
does the FDA Report require that the liquid phase pass through the solid
phase “drop-wise,” as argued by Appellant. App. Br. 14—15.
Ricker expressly distinguishes forced liquid injection from the use of
a vacuum or gravity—the methods discussed in the FDA Report. Ricker
112. In fact, Ricker teaches that forced liquid injection avoids the
problem—back pressure—that Appellant states occurs with the FDA
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procedure or Wang’s method. Compare Ricker 112 (“Driving the liquid-
soluble sample flow through the integrated structures described herein with
the metering piston of an autosampler, rather than by using a vacuum or
gravity[,] eliminates backpressure variations encountered in preexisting fluid
processing cartridges or columns.”), with App. Br. 14 (“[W]hen the
inventors tried these using the FDA protocol, back pressure and mechanical
instability occurred with stacked cartridges. Since Wang mimics the FDA
Report, it would have encountered the same problems.”).
In view of the express teachings of Ricker, we find that the FDA
Report’s teaching to “not use a vacuum to speed up the elution process,”
FDA Report 3,^8, would not have discouraged a person of ordinary skill in
the art from using Ricker’s automated process, including forced liquid
injection, to clean up a foodstuff sample using the sorbents disclosed in
Wang. See Allied Erecting and Dismantling Co. v. Genesis Attachments,
LLC, 825 F.3d 1373, 1382 (Fed. Cir. 2016) (no teaching away, where
proposed combination does not utilize the feature that the prior art taught
could be achieved “only with very great difficulty, if at all” and there is no
teaching away from feature that is utilized in the combination).
Less Than 10 Minutes
The Examiner finds that the combination of Ricker and Wang fails to
disclose that the conditioning, flowing, and eluting steps are completed in
less than 10 minutes, as recited in claim 23. Final Action 5. Nevertheless,
the Examiner finds that a person of ordinary skill in the art would have
optimized the processing time by modifying the cross-sectional flow area
and the amount of sorbent in each layer to accommodate flow rates such that
the recited steps could be accomplished in under 10 minutes. Id.
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Appellant argues that it is not predictable that a sample could be
prepared in less than 10 minutes, when the FDA procedure (which Wang
follows) requires 1.5 hours to prepare a sample for analysis. App. Br. 13,
17. In addition, Appellant argues that scaling up the apparatus would not
necessarily result in a faster processing time. Id. at 24—25; Reply Br. 3—5.
We are not persuaded that Appellant identifies reversible error in the
Examiner’s analysis or findings regarding the “less than 10 minutes”
limitation of claim 23.
First, we are not persuaded that the time limitation recited in the
claims is comparable to the 1.5 hour time period discussed in the FDA
Report. The FDA Report states that certain changes to the procedure “allow
one person to prepare 12 portions for analysis in about 1.5 hours.” FDA
Report 2. The referenced changes pertain to steps 4—9 of the sample
preparation procedure, including mixing on a rotation shaker (step 4),
centrifuging to separate aqueous phase from oil and solids (step 5), and
centrifuging of aqueous phase in a filter tube (step 6). Compare FDA
Report 1—2 (changes in the second (current) revision), with id. at 3 (sample
preparation steps 1—9). The 1.5 hour time period discussed in the FDA
Report includes (for each group of samples) 20 minutes of mixing on a
rotating shaker, 15 minutes of phase separation centrifuging, and 2-4
minutes of filter tube centrifuging. Id. at 3. None of these steps is included
in claim 23 ’s time limit of “less than 10 minutes,” which pertains only to the
conditioning, flowing, and eluting steps. App. Br. 29 (claim 23). The
recited steps correspond to only a subset of the steps of the FDA procedure
that takes about 1.5 hours to complete.
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Moreover, the 1.5 hours discussed in the FDA Report is the time
needed to prepare 12 portions for analysis, with the mixing and centrifuging
steps being carried out in groups of 6, and the SPE steps being carried out in
one group of 12. FDA Report at 1—2. In contrast, claim 23 is silent on the
number or volume of aqueous samples that can be prepared in less than 10
minutes. Accordingly, no direct comparison can be made.
Second, we are not persuaded that the method taught by the
combination of Ricker and Wang could not (or would not) have been
optimized to allow the conditioning, flowing, and eluting steps to be
completed in less than 10 minutes. Both Ricker and Wang suggest the
desirability of minimizing sample preparation time. Ricker 12 (criticizing
time-consuming nature of prior offline sample preparation methods); Wang
91 (second column: the aim of our work is to develop a simple, fast and
inexpensive method to determine acrylamide levels in food).
Appellant does not identify differences between the conditioning,
flowing, and eluting steps, as taught by the combination of Ricker and
Wang, and the conditioning, flowing, and eluting steps, as taught by
Appellant, such that only the latter can be completed in less than 10 minutes.
Appellant argues that the Examiner’s analysis fails to take into account
reaction rates and adsorption rates. App. Br. 24—25; Reply Br. 3—5. That
argument is unconvincing because the combination of Ricker and Wang
teaches the same sorbents (Oasis HLB and Bond Elut-Accucat) and the same
type of sample (aqueous sample extracted from foodstuff) as used in
Appellant’s method. Compare Spec. Tflf 33, 34, 39, with Wang 92.
Appellant’s Specification attributes the reduced cycle time (less than 10
minutes) to the use of a single cartridge containing two sorbent materials.
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Spec. 149. However the same arrangement is taught by the combination of
Ricker and Wang. Ricker Fig. 7B (showing two distinct stationary phase
materials 22A, 22B in a stacked arrangement in cartridge 2C); Wang 92
(sample is directly passed through both Oasis HLB and Bond Elut-Accucat).
We also note that the amount of sorbent is similar in both methods.
Compare Spec. 137 (typical cartridge contains 100 mg of each of the first
and second sorbents), with Ricker 134 (the stationary phase comprises 100—
200 mg of separation media).
Based on the foregoing, the weight of the evidence supports the
Examiner’s conclusion of obviousness. Therefore, the § 103(a) rejection
based on Ricker and Wang is sustained.
CONCLUSION OF LAW AND DECISION
The decision of the Examiner rejecting claims 23, 25, 27—35, and 37—
39 is affirmed.
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).
AFFIRMED
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