Ex Parte WU et al

Patent Trial and Appeal Board

Dec 20, 2018

13925547 (P.T.A.B. Dec. 20, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/925,547 06/24/2013
95896 7590 12/25/2018
Knobbe, Martens, Olson & Bear, LLP
2040 Main Street
14th Floor
Irvine, CA 92614
FIRST NAMED INVENTOR
Betty WU
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
HANLB.018Cl (P-9094C2) 8766
EXAMINER
FORMAN, BETTY J
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
12/25/2018 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):
efiling@knobbe.com
j ayna.cartee@knobbe.com
ip.docket@bd.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BETTY WU, JOHN S. ALTHAUS,
SUNDARESH N. BRAHMASANDRA, KAL YAN HANDIQUE, and
NIKHIL PHADKE
Appeal2017-002203
Application 13/925,547
Technology Center 1600
Before DEMETRA J. MILLS, ULRIKE W. JENKS, and TA WEN CHANG,
Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Appellant1 submits this appeal under 35 U.S.C. § 134(a) involving
claims to a diagnostic apparatus. Examiner rejected the claims as obvious
and on the grounds of non-statutory obviousness type double patenting. We
have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 Appellant is the applicant, HandyLab Inc., which, according to the Appeal
Brief is the real party in interest. Appeal Br. 3.
Appeal2017-002203
Application 13/925,547
STATEMENT OF THE CASE
Claims 24--43 are on appeal, and can be found in the Claims
Appendix of the Appeal Brief. Claim 24 is representative of the claims on
appeal, and reads as follows:
24. A diagnostic apparatus configured to isolate and amplify
polynucleotides in a sample solution, the apparatus comprising:
a first processing region comprised of a plurality of
magnetic binding particles, the binding particles having
polycationic polyamide ligands bound to the surfaces thereof,
wherein the binding particles are configured to preferentially
bind polynucleotides in the sample solution at a first pH and
release the polynucleotides at a second pH, wherein the first pH
is about 9. 5 or less, wherein the second pH is about 10 or greater;
a reservoir comprising a release liquid having a pH of
about 10 or greater, the release liquid being used to release the
polynucleotides from the binding particles at the second pH;
a second processing region to receive the polynucleotides
released from the binding particles in the first processing region,
the second processing region comprising one or more one or
more lyophilized particles containing one or more amplification
reagents; and
an amplification region comprising:
an inlet;
a microfluidic chamber;
an outlet; and
an inlet valve and an outlet valve, the inlet and outlet
valves configured to isolate the sample solution in the
microfluidic chamber during amplification.
Appeal Br. 28 (Claims Appendix).
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Appellant requests review2 of the following grounds of rejection made
by Examiner:
I. Claims 24--29, 31-33, 35-39, 42, and 43 under 35 U.S.C. § I03(a) as
unpatentable over Blackbum, 3 McMillan, 4 Chen, 5 Baker, 6 and
Akhaven-Tafti. 7
II. Claims 24--33, 35--40, 42, and 43 under 35 U.S.C. § I03(a) as
unpatentable over Blackbum, McMillan, Chen, Baker, Akhaven-Tafti,
and Amold. 8
III. Claims 24--29, 31-33, 35-39, 42, and 43 under 35 U.S.C. § I03(a) as
unpatentable over Blackbum, McMillan, Chen, Baker, Akhaven-Tafti,
and Terbrueggen. 9
The rejections (1.-111.) each rely upon the teaching of Blackbum,
McMillan, Chen, Baker, and Akhaven-Tafti; rejection (II.) further includes
2 Examiner has also rejected claims 24--38 on the ground of nonstatutory
obviousness-type double patenting as being unpatentable over claims 1-28
of Wu et al. (US 8,470,586 B2, issued June 25, 2013 ("Wu")). Final Office
Action mailed August 7, 2015 ("Final Act.") 14--15. Appellant has not
argued the merits of the double-patenting rejection but requests that the
rejection be held in abeyance until the application is otherwise in condition
for allowance. Appeal Br. 10. Because Appellant presents no arguments, we
summarily affirm this rejection.
3 Blackbum, US 2003/0190608 Al, published Oct. 9, 2003.
4 McMillan et al., US 2002/0039783 Al, published Apr. 4, 2002
("Mc Millian").
5 Chen et al., US 2004/0161788 Al, published Aug. 19, 2004 ("Chen").
6 Baker, EP 1 036 082 Bl, published May 29, 2002.
7 Akhavan-Tafti, US 2006/0234251 Al, Oct. 19, 2006.
8 Arnold et al. US 5,599,667, issued Feb. 4, 1997 ("Arnold").
9 Terbrueggen et al., US 2004/0053290 Al, published Mar. 18, 2004
("T erbrue ggen").
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Arnold; and rejection (III.) further includes Terbrueggen. Because the same
issue is dispositive for all of three rejections, we will consider the rejections
together.
The issue is: Does the preponderance of evidence of record support
Examiner's conclusion that the combination of Blackbum, McMillan, Chen,
Baker, and Akhaven-Tafti teach a diagnostic apparatus having three
processing regions and using magnetic beads containing a polycationic
polyamide ligand that can release the bound polynucleotide at a pH of about
10 or greater?
Findings of Fact
We agree with and adopt Examiner's findings of fact and reasoning
regarding the scope and content of the prior art as set out in the Answer and
Final Office Action mailed August 7, 2015 ("Final Act."). For emphasis
only we highlight the following:
FF 1. Blackbum teaches a microfluidic device with microchannels that have
separated regions. Blackbum, Abstract. Figure 8, reproduced below
shows such a microfluidic device.
Figure 10 shows a DNA amplification chamber 22 in fluid
communication with the DNA separation chamber 16. Blackbum
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,r 334. A buffer injection port 18 and a waste outlet port are provided
that are in communication with the DNA separation chamber. Id.
i-f334. The amplification chamber has reagent injection port 24 and a
waste outlet port 26. Id. ,r 334. In this device DNA separation is
accomplished by manipulating paramagnetic microbeads that are in
chamber 16. Id. ,r 337. The system also contains fluid flow control
valves 30, 32, and 34. Id. ,r 335. Fluid flow through the system can
occur via a microfluidic pumping system or through capillary action.
Id. ,r 335. Fluid control valve 32 allows for DNA to pass from
separation chamber 16 into the amplification chamber 22, and control
valve 34 allows for amplified DNA to pass into detection chamber 28.
Id. ,r 340, see also ,r,r 341-344.
FF2. Blackbum teaches storage modules that "may contain any number of
reagents, buffers, enzymes, electronic mediators, salts, etc., including
freeze dried reagents." Blackbum ,r 292.
FF3. McMillan teaches a device for lysing cells and sampling fluids in a
cartridge. McMillan, Abstract. McMillan teaches cartridges that are
designed to process fluid sample and amplify nucleic acids, using for
example PCR. Id. ,r 47. Figure 2, reproduced below, shows an
exemplary cartridge.
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121--++-~-·
107 l 11 l(}9
~t=;E=~l=f:::;
136
141
l.45
Figure 2 shows a plan view of the fluid sampling cartridge. Id. ,r 22.
McMillan teaches a cartridge containing a port for introducing fluid
sample into the cartridge and mixing it with a lysing reagent. Id. f 48.
The cartridge contains a flow-through component 122 that comprises
either a channel or chamber as part of the cartridge and contains at
least one solid support, such as a bead, for capturing a desired analyte.
Id. ,r 50. The cartridge contains flow controllers that transport elusion
fluid and analyte into a reagent chamber 141 containing PCR
reagents. Id. ,r,r 53, 75. In an alternative embodiment McMillan
teaches that the elution solution can also include PCR reagents. Id.
,r 75. McMillan teaches that fluid is prevented from flowing upstream
in the cartridge by flow controllers that are present in the channels. Id.
,r 70. The reagent chamber 141 is in fluid communication with a
reaction chamber 143 for PCR amplification. Id. ,r 54.
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FF4. Chen teaches a sample processing tubule. Chen, Abstract. Chen
teaches using nucleic acid amplification and detection using PCR
reagents. Id. ,r 78. The PCR reagent may be a dried reagent. Id. ,r 72.
FF5. Baker teaches a method for extracting nucleic acids from biological
materials. Baker ,r 1. Baker teaches contacting blood with solid phase
material, such as for example "polystyrene beads[, or] para magnetic
beads." Id. ,r 13. Baker teaches treating the surface of the solid phase
with "a substance which can introduce a charge e.g. positive charge
on the surface." Id. ,r 14. Baker teaches that the solid phase system can
incorporate histidine or polyhistidine that tend to "bind nucleic acids
at low pH e.g. less than six and will then release the bound nucleic
acid when the pH is increased e.g. to greater than 8. Alternatively the
nucleic acids are bound at substantially neutral pH to an aminated
surface and released at very high pH." Id. ,r 15, see also claim 6 ("the
nucleic acid binds to the solid phase at a substantially neutral pH and
is released from the solid phase at a pH of greater than 10.").
FF6. Akhavan-Tafti teaches binding nucleic acids onto a solid phase
surface. Akhavan-Tafti, Abstract. Akhavan-Tafti teaches magnetic
microparticles, such as magnetic silica or magnetic polymeric
particles (id. ,r 49), that are "generally surrounded by an adsorptively
or covalently bound layer to shield the magnetic component. Nucleic
acid binding groups can be covalently bound to this layer thereby
coating the surface." Id. ,r 48.
Nucleic acid binding groups include, for example,
carboxyl, amine and ternary or quaternary onium groups
or mixtures of more than one of these groups. . . . Such
solid phase materials retain the bound nucleic acid with
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great tenacity and resist removal or elution of the nucleic
acid under most conditions used for elution known in the
prior art .... [T]he ternary or quaternary onium solid phase
materials remain positively charged regardless of the pH
of the reaction medium.
Id. ,I 52.
FF7. Arnold teaches the use of polycationic solid supports in the
purification of nucleic acids from solutions containing contaminants.
Arnold, Abstract. The solid support should "have a cationically
modified surface of sufficient charge density to enable the adsorption
of the desired polynucleotide under appropriate conditions of salt,
detergent and temperature .... Examples of such moieties include ...
polymers with amine functionalities such as polylysine, polyarginine,
polyethylenimine, and polyallylamine." Id. 9: 11-26.
Principle of Law
"If the claim extends to what is obvious, it is invalid under§ 103."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,419 (2007).
Analysis
Appellant contends that (a) the use of the term "and/ or" in
formulating the rejection is improper because it is not clear how the
articulated reason renders the invention obvious (Appeal Br. 13-14); (b) the
references do not teach binding particles that can release polynucleotide
once pH is raised to about greater than 10 (id. at 15-17); ( c) the references
do not disclose a second processing region (id. at 18); ( d) the references do
not teach a reservoir containing a release liquid having a pH of about 10 or
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greater (id. at 20); (e) the references do not teach an amplification region
with an inlet and an outlet valve (id. at 22); (j) the references do not teach
binding particles containing poly cationic polyamide ligands such as poly 1-
lysine (id. at 23-25); and (g) the references do not teach the claimed
processing volume (id. at 25-26).
We are not persuaded by Appellant's contentions and generally agree
with Examiner's statement of the rejection and responses to Appellant's
arguments as set forth in the Answer and Final Office Action which we
adopt and incorporate herein by reference. We find that Examiner has
provided sufficient evidence combined with an articulated rationale to
support a prima facie case of obviousness. We provide the following
additional comment to arguments set forth in the Appeal Brief.
a. The use of alternative phrasing in the statement of rejection does not
render the rejection unclear.
We are not persuaded by Appellant's contention that the use of the
phrase "and/or" is improper because it allegedly makes it impossible to
determine which reference is the primary reference. Appeal Br. 12-14; see
Reply Br. 7 ("it impossible to determine which primary reference the
Examiner is relying on for features of the independent claims").
How the references are put together A in view of B, or B in view of A,
or the designation of a primary and secondary reference is immaterial as it is
the combination together that is important. Our reviewing Court has found
"that such differing forms of expression did not constitute different grounds
of rejection, were of little consequence, and that basing arguments on them
was 'attempting to make a mountain out of a mole-hill."' In re Bush, 296
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F.2d 491 496 (CCPA 1961)(citingJn re Cowles, 156 F.2d 551,554 (CCPA
1946)).
Here, Examiner explains that the use of alternative phrasing was to
point out that "Blackbum and McMillan teach very similar apparatus that are
particularly relevant to the claimed invention." Ans. 4; see FF1-FF3.
Examiner acknowledges that even though Blackbum and McMillan teach
similar devices they do have elements that are present in one reference and
not in the other. See Ans. 7. In the body of the rejection Examiner uses both
the Blackbum and McMillan (see Final Act. 3-5) and articulates how and
why one of ordinary skill would modify the others device based on the
combined teachings of the references. As pointed out in the Answer, the
combination of how the references were modified was presented in the Final
Action. See Ans. 3-7; see Final Act. 3-5.
Furthermore, "[t]here has never been a requirement for an examiner to
... to explain every possible difference between the prior art and the
claimed invention in order to make out a prima facie rejection." In re Jung,
637 F.3d 1356, 1363 (Fed. Cir. 2011). Upon review of the Final Office
Action mailed Aug. 7, 2015 ("Final Act."), we find that the body of the
rejection (Final Act. 3-10), as presented by Examiner sufficiently articulates
how the combination of the limitations in each of the references was put
together in order to arrive at the conclusion of obviousness. Accordingly, we
do not agree with Appellant's position that the rejection as presented by
Examiner was lacking to the point that Appellant could not have reasonably
responded.
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b. Binding particles that release polynucleotide at pH 10 or greater.
We are not persuaded by Appellant's contention that the binding
particles of Baker, or those of Akhavan-Tafti, do not meet the claimed
limitations. See Appeal Br. 16.
Claim 24 recites in pertinent part: "binding particles having
polycationic polyamide ligands bound to the surfaces thereof, wherein the
binding particles are configured to preferentially bind polynucleotides in the
sample solution at a first pH and release the polynucleotides at a second pH,
wherein the first pH is about 9.5 or less, wherein the second pH is about 10
or greater."
Examiner interprets this claim limitation to recite a pH range for
binding and a pH range for release of the nucleic acid from the particles.
Specifically, that the limitation "first pH is about 9.5 or less" encompasses a
pH well below 9.5 (see Ans. 8), or more specifically a range from 9.5 to
zero. We see no error with Examiner's interpretation that the limitation
"about 9.5 or less" encompasses any pH that is below 9.5. See Ans. 8. We
also agree with Examiner that the interpretation "greater than 1 O" reasonably
encompasses a range of pH from just above pH 10 all the way up to pH 14.
See id.
Here, Examiner finds, and Appellant does not dispute, that Baker
discloses magnetic beads containing polyhistidine linkers that bind nucleic
acid at neutral pH and release nucleic acid at a pH greater than 10. See Final
Act. 5; see Appeal Br. 16 ("Claim 6 of Baker recites 'wherein the nucleic
acid binds to the solid phase at a substantially neutral pH and is released
from the solid phase at a pH of greater than 10. "'); FF5.
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Appellant contends that Baker does not meet the second pH of claim
39 that recites a pH that is "about 11 or greater." Appeal Br. 16.
We are not persuaded by Appellant's contention because Examiner
points out Baker's teaching of releasing nucleic acids from the bound
particles at a pH of greater than 10, and this would encompass a pH of 11.
See Ans. 8. We see no error with the interpretation that a pH of "about 10 or
greater" encompasses a pH range from 10 to 14. Therefore, Baker teaches
the release of nucleic acids from the bound particles using a pH range that
overlaps with the pH range disclosed in claim 39. "A prima facie case of
obviousness typically exists when the ranges of a claimed composition
overlap the ranges disclosed in the prior art .... The normal desire of
scientists or artisans to improve upon what is already generally known
provides the motivation to determine where in a disclosed set of percentage
ranges is the optimum combination of percentages." In re Peterson, 315
F.3d 1325, 1329-30 (Fed. Cir. 2003). We consider only those arguments
actually made by Appellant. Arguments that Appellant could have made but
chose not to make in the Briefs have not been considered and are deemed to
be waived. See 37 C.F.R. § 4I.37(c)(l)(iv).
c. A second processing region.
Appellant contends that the references do not disclose "the second
processing region comprising one or more ... lyophilized particles
containing one or more amplification reagents." Appeal Br. 18. "The
Examiner has not explained how the DNA amplification chamber 22 of
Blackbum can be both the claimed 'second processing region' and the
claimed 'amplification region."' Appeal Br. 19. Appellant contends that
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Examiner conflates two separate claim elements as a single element. Reply
Br. 4. Specifically, Examiner interprets the second processing region and the
amplification region as one element.
On this point, we agree with Appellant that Examiner's claim
interpretation as set out in the Answer is an error. See Becton, Dickinson and
Co. v. Tyco Healthcare Group, LP, 616 F.3d 1249, 1254 (Fed. Cir. 2010)
("Where a claim lists elements separately, 'the clear implication of the claim
language' is that those elements are 'distinct component[s]' of the patented
invention".) In other words, we agree with Appellant that Blackbum does
not meet the claimed apparatus having three processing regions.
The rejection, however, is based on the combination of Blackbum and
McMillan and presenting arguments that only address Blackbum is in error.
See In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Because
Examiner is not relying on Blackbum alone in order to meet the claim
elements of the "second processing region to receive polynucleotides ... and
amplification region," we do not agree with Appellant's contention that
Blackbum does not meet all the claim limitations. See Final Act. 3-5.
Just because we do not agree with Examiner's claim interpretation as
set out in the Answer, does not mean we do not agree with the rejection as
formulated in the Final Office Action that relies on both Blackbum and
McMillan to arrive at the claimed device. In the Final Office Action,
Examiner acknowledges that "Blackbum teaches [that] the apparatus further
includes freeze dried reagents (i-f 292) but does not specifically teach [that]
the second processing region comprises the dried reagents." Final Act. 3.
Here, Examiner identifies structures in McMillan that meet the limitation of
a first processing region, a second processing region, and a separate
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amplification region. See Final Act. 3--4 ("a first processing region (122) ...
and a second processing region (141) ... and an amplification region (143)
... comprising an inlet, microfluidic chamber, an outlet and valves (see
unlabeled valve above amplification region 143, Fig. 2)").
McMillan teaches that "[ f]luid is prevented from flowing upstream in
the cartridge by flow controllers 123 in channels 121, 129, and 131."
McMillan ,r 70, see also ,r 51 ("flow controllers 41A and 41B may be, e.g.,
valves, flow diverters, or fluid diodes."). McMillan teaches that it is
preferred to incorporate "flow controllers, e.g. valves" to prevent upstream
flow but when that is not it is possible an alternative construction is using "a
continuously flowing fluid stream to be guided, divided and diverted to
various regions within the cartridge without the incorporation of valves." Id.
,r 101. In other words, McMillan teaches alternative ways to prevent
backflow of fluids in the system.
Examiner acknowledges that McMillan "does not specifically teach
[that] the amplification region comprises an inlet valve, [but finds that] it
would have been obvious to one of ordinary skill in the art to provide the
amplification region with an inlet valve to thereby prevent back flow out of
the region as suggested by McMillan." Final Act. 3--4 ( citing McMillan
,r 51-55 and ,r 69-71 and ,r 101); FF3. We agree with Examiner's position
that McMillan suggests using flow controllers to adjust the flow through the
system, and when this teaching is combined with the teaching in Blackbum
that isolates the amplification region in the "microfluidic chamber (22) ...
[using] inlet/outlet channels and valves (32/34)" we agree that it would have
been obvious to add a similar valve set up into the amplification region in
McMillian. See Final Act. 3.
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d. A reservoir holding a release buffer having a pH of 10 or greater.
We are not persuaded by Appellant's contention that the references do
not teach a reservoir comprising release liquid having a pH of about 10 or
greater. Appeal Br. 20.
Here, Examiner acknowledged that neither Blackbum nor McMillan
disclose magnetic beads that capture nucleic acid at a lower pH and release it
at a pH of about 10 or greater; this feature, however, is taught in Baker. See
Final Act. 5 ("references do not teach polycationic polyamide particles");
FF5. We find no error with Examiner's position that it would be obvious to
substitute particles taught in Baker for the particles used in the apparatus as
suggested by the combination of McMillan and Blackbum. It is obvious to
those skilled in the art to substitute one known equivalent for another, be
those equivalents method steps or apparatus components. See In re
Omeprazole Patent Litig., 483 F.3d 1364, 1374 (Fed. Cir. 2007). Here, the
combination of references teaches the use of Baker's particles in the device
that would also require a release buffer that is at a pH of 10 or greater.
In the Answer, Examiner directs attention to Blackburn's injection
port 18 through which release buffer is injected into the system. Ans. 12.
This injection port 18 is reasonably in communication with a reservoir that
holds the release buffer, even if that reservoir is not shown in the figures.
Examiner, however, is not relying only on Blackbum to show a reservoir
containing release buffer. Examiner relies on McMillan's device that
specifically teaches a reservoir for storing elution fluid. McMillan teaches
"elution fluid from the storage region 127 is forced to flow down channel
131 and through the component 122, thus releasing the nucleic acid from the
component into the elution fluid. At this point, the flow controllers 41A and
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4 lB are reconfigured to prevent the elution fluid from flowing through the
flow controller 41A and to permit the elution fluid to flow through the flow
controller 4 lB into the reagent chamber 141." McMillan ,r 71.
In the Final Action, Examiner finds that both Blackbum and
McMillan teach capture and release from particles by applying an elution
fluid that has a pH of 10 or above as taught in Baker. See Final Act. 6 ("The
artisan would have been further motivated to use capture and release via pH
changes of Baker to thereby provide PCR-ready nucleic acids in the
downstream PCR chambers of Blackbum, McMillan, and/or Chen"). In
other words, Examiner establishes that it is the particle that is used to
capture the nucleic acid that will dictate what type of elution buffer is
required to release the nucleic acid from the particle. For example, if using
Baker's capture particles in the device then the elution condition taught in
Baker would have to be applied. See FF5. Based on these teachings we agree
that the combined references suggest a reservoir containing elution liquid
having a pH of 10 or greater as required by the claims.
e. An amplification region having inlet and outlet valve.
Appellant contends that the combination is not obvious because
McMillan does not teach an amplification region having an inlet and an
outlet valve. Appeal Br. 21.
Appellant errs in attacking the references individually, as the rejection
is based on a combination of references. See Merck & Co., 800 F.2d at 1097.
The references cannot be read in isolation, but for what they teach in
combination with the prior art as a whole. See id. We are not persuaded by
Appellant's contention that the references as combined by Examiner do not
teach and inlet and outlet valve on either side of the amplification region.
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Here, Examiner acknowledged that McMillan does not disclose an inlet and
an outlet valve on either side of the amplification region, but instead looks to
the teachings within McMillan itself as well as Blackbum to suggest adding
valves in order to prevent backflow. See Final Act. 4. We agree with
Examiner that Blackbum suggests an amplification region that contains an
inlet and an outlet valve and that the use of valves to prevent backflow is
recognized as one means of controlling the fluid direction in a microfluidic
system. The law does not require that the teachings of the reference be
combined for the reason or advantage contemplated by the inventor, as long
as some suggestion to combine the elements is provided by the prior art as a
whole. In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992); In re Kronig,
539 F.2d 1300, 1304 (CCPA 1976). Accordingly, we agree with Examiner
that the teaching of the references sufficiently suggest adding valves to the
amplification region, namely to prevent backflow of fluid in the system.
f Binding particles containing polycationic polyamide ligands such as
poly-I-lysine.
We are not persuaded by Appellant's contention that the references as
combined do not teach the poly-L-lysine containing particles. Appeal Br. 24.
Specifically, Appellant contends that Examiner has improperly cherry
picked unrelated characteristics of binding particles among the references.
Id.
Picking and choosing may be inappropriate in an anticipation
rejection but is entirely proper an obviousness rejection. See In re Arkley,
455 F.2d 586, 587-588 (CCPA 1972). Here, Examiner is relying on the
teaching of Baker to disclose magnetic particles containing polycationic
polyamide ligands for use in capturing nucleic acids. Baker specifically
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discloses polyhisidine containing paramagnetic particles. Baker ,r,r 13-15;
FF5. Baker teaches that these polyhisidine containing particles bind nucleic
acid at one pH and release the nucleic acid and another pH. FF5.
Arnold similarly teaches using polycationic support matrix for the
purpose of purification nucleic acids from solution containing contaminants.
FF7. Arnold teaches that if the particles are magnetic then magnetic field
separation can be used in the purification procedure. Arnold 5: 16-19, see 7:
3-7. Arnold further teaches that "[t]he support should have a cationically
modified surface of sufficient charge density to enable the absorption of the
desired polynucleotide under appropriate conditions .... [C]harges may be
introduced by a range of cations .... [These include] polymers with amine
functionalities such as polylysine, polyarginine, polyethyleimine, and
polyallylamine." Id. 9: 10-26.
We find no error with Examiner's position that it would be obvious to
substitute one polycationic support, such as the poly-1-ysine particles taught
by Arnold, for another polycationic support, such as the polyhistidine
particle taught by Baker, as each particle is taught to be useful for the same
purpose, namely for purifying nucleic acids. There is a reasonable
expectation these similar polycationic supports would function in a similar
manner. See Final Act. 10-12. "Obviousness does not require absolute
predictability of success ... all that is required is a reasonable expectation of
success." In re Drage, 695 F.3d 1334, 1338 (Fed. Cir. 2012) (quoting In re
Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) (citing In re O'Farrell, 853
F.2d 894, 903-04 (Fed.Cir.1988)).
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g. Processing volume.
Appellant contends that Examiner has not established that the
combined references teach that the volume of binding particles is less than 5
microliters. Appeal Br. 25-26.
We are not persuaded. Examiner finds, and Appellant does not
contest, that McMillan teaches that "the extraction chamber has a volume
capacity in the range of 0.1 to 25 µL, and the volume of fluid sample forced
to flow through the device is in the range of 1 to 100 mL, enabling
concentration factors of 100 or greater." McMillan ,r 161; Appeal Br. 26,
Final Act. 9. Examiner acknowledges that "the references are silent
regarding a total volume of particles, [but finds that] it would have been
obvious to one of ordinary skill in the art at the time the claimed invention
was made to use a particle volume of less than [the] reaction chambers."
Final Act. 9. Here, Examiner established that the size of the extraction
chamber in McMillan has a volume capacity of 0.1-25 µl, indicating that the
volume that can be occupied by the particles in the chamber could range
0 .1-25 µl. See Final Act. 9. A prima facie case of obviousness typically
exists when the claimed range overlaps with ranges disclosed in the prior art.
See Peterson, 315 F.3d at 1329-30. Here, the claimed volume 5 µl overlaps
with the chamber volume range taught in McMillan rendering claimed
volume obvious. We also agree with Examiner that the bead volume in
McMillan's chamber would be less than the chamber volume and that the
artisan would have been motivated to optimize the volume based on flow
characteristics. See Final Act. 9 ("artisan would have reasonably selected a
particle volume ( e.g. less than 5 µl) based on the size of the supply, metering
and chamber volumes to thereby optimize the particle volume for movement
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Appeal2017-002203
Application 13/925,547
through and reactions within the chambers."). [W]here the general
conditions of a claim are disclosed in the prior art, it is not inventive to
discover the optimum or workable ranges by routine experimentation." In re
Aller, 220 F.2d 454,456 (CCPA 1955).
Appellant has not met their burden of showing that Examiner erred in
rejecting the claims, or otherwise rebutted Examiner's response in the
Answer. Accordingly, we affirm the rejection under 35 U.S.C. § 103(a) as
being obvious.
SUMMARY
We affirm the rejection of claim 24 under 35 U.S.C. § 103(a)
Blackbum, McMillan, Chen, Baker, and Akhaven-Tafti. Claims 25-29, 31-
33, 35-39, 42, and 43 were not separately argued and fall with claim 24.
37 C.F.R. § 41.37 (c)(l)(iv).
We affirm the rejection of claims 24, 30, 40 under 35 U.S.C. § 103(a)
over Blackbum, McMillan, Chen, Baker, and Akhaven-Tafti, and Arnold.
Claims 31-33, 35-39, 42, and 43 fall with claims 24, 30, and 40.
We affirm the rejection of claim 24 under 35 U.S.C. § 103(a) over
Blackbum, McMillan, Chen, Baker, Akhaven-Tafti, and Terbrueggen.
Claims 25-29, 31-33, 35-39, 42, and 43 fall with claim 24.
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).
AFFIRMED
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