Ex Parte Van Der Wijk et al

Patent Trial and Appeal Board

Jun 20, 2016

12299806 (P.T.A.B. Jun. 20, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/299,806 11/06/2008 Thea Van Der Wijk
24737 7590 06/22/2016
PHILIPS INTELLECTUAL PROPERTY & STANDARDS
465 Columbus A venue
Suite 340
Valhalla, NY 10595
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.
2006P01194WOUS 3038
EXAMINER
DO,PENSEET
ART UNIT PAPER NUMBER
1677
NOTIFICATION DATE DELIVERY MODE
06/22/2016 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):
marianne.fox@philips.com
debbie.henn@philips.com
patti. demichele@Philips.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte THEA VAN DER WIJK, EDUARD GERARD MARIE
PELSSERS, and JESSICA AMADI0 1
Appeal2014-006035
Application 12/299,806
Technology Center 1600
Before LORA M. GREEN, FRANCISCO C. PRATS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for detecting a target in a sample employing magnetic particles, which have
been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Competitive assays to detect target molecules of interest in a sample
using solid phase supports are well-known. (Spec. 1.) According to
1 Appellants identify the Real Party in Interest as Koninklijke Philips
Electronics, N.V. (Appeal Br. 3.)
Appeal2014-006035
Application 12/299,806
Appellants, "because there is a difference in mobility of the target molecules
free in solution compared to the target molecules bound to the surface or to a
label," using the assay for quantitative measurements is difficult. (Id. at 1-
2.) In addition, "the limited mobility of the targets bound to the surface of
the label results in a relatively slow reaction time." (Id. at 2.) The claimed
invention attempts to alleviate one or more problems with these known
assays. (Id.)
Claims 1, 4--10, 12, 15-20, 26, and 31-35 are on appeal. Claim 1 is
illustrative and reads as follows:
1. A method for detecting a target in a sample suspected
of containing the target, comprising:
a) contacting the sample and a first binding molecule
attached to a magnetic particle, at the same time or at different
times, with a second binding molecule attached to a solid
support, the second binding molecule being either identical to
the target, or being a target homologue, wherein the first
binding molecule is capable of binding to the second binding
molecule and the first binding molecule is attached to said
magnetic particle via a strong binding couple, and wherein the
target is capable of interfering with this binding; and applying a
magnetic force to bring the magnetic particle into close
proximity with the solid support;
b) removing the first binding molecules not bound to the
second binding molecules; and
c) detecting the number of magnetic particles bound to
the solid support by the binding of the first binding molecule to
the second binding molecule, wherein the first binding
molecule is capable of selectively binding the target in the
sample and the second binding molecule, and wherein
contacting step a) comprises allowing competition of the
second binding molecule with the target for said selective
binding to the first binding molecule.
(Appeal Br. 15.)
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Application 12/299,806
The following grounds of rejection by the Examiner are before us on
review:
1. Claims 1, 4--10, 12, 19, 26, and 31-35 under 35 U.S.C. § 103(a) as
unpatentable over Rohr2 and Rao. 3
2. Claims 15-18 under 35 U.S.C. § 103(a) as unpatentable over Rohr,
Rao, and Henderson.4
3. Claim 20 under 35 U.S.C. § 103(a) as unpatentable over Rohr,
Rao, and Cubicciotti. 5
DISCUSSION
Claims 1, 4-10, 12, 19, 26, and 31-35
The Examiner finds that Rohr teaches a competitive format assay as
claimed except for the first binding molecule being "bound to said magnetic
particle via a strong binding couple." (Final Action 4--5; Ans. 2-3.) The
Examiner finds that Rao fills this gap teaching that "capture antibodies can
be bound to magnetic particles via a strong binding couple such as
avidin/streptavidin and biotin." (Id.) In particular, the Examiner finds Rao
discloses an assay in which magnetic particles can be coated with
"avidin/streptavidin and the capture monoclonal antibody is coated with
biotin." (Ans. 3 (citing Rao 12:7-13:54); Ans. 8 (noting that Rao 12:19-24
discloses that a magnetic particle can be coated with streptavidin, while the
2 Rohr et al., US 5,445,971, issued Aug. 29, 1995.
3 Rao et al., US 5,660,990, issued Aug. 26, 1997.
4 Henderson et al., US 6,897,015, issued May 24, 2005.
5 Cubicciotti, US 6,762,025, issued Jul. 13, 2004.
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Application 12/299,806
coating on the collection surface and the capture agent could comprise
biotin).)
The Examiner also notes that Rohr teaches in Example 2 that
magnetic particles can be coated with avidin to detect bitoin in a sample.
(Ans. 9.) The Examiner concludes from the teachings of these references
that it would have been obvious to one of ordinary skill in the art to modify
the competition assay of Rohr to detect different targets than biotin by using
the Rao immobilization approach of using a strong binding couple such as
avidin/biotin pair or a streptavidin/biotin pair to bind a first binding
molecule, such as an antibody, to magnetic particles depending on the
purpose of using the magnetic particles. (Final Action 5; Advisory Action 9;
Ans. 9.)
Appellants' arguments do not persuade us that the Examiner's factual
findings and conclusion that claim 1 would have been obvious from Rohr
and Rao are erroneous.
Appellants contend the rejection is improper because Rao fails to
disclose and provides no motivation to modify Rohr to include a strong
binding couple to attach a first binding molecule to a magnetic particle being
that Rao does not "us[ e] a strong binding couple to attach a first binding
molecule to a magnetic particle as featured in the present claims." (Appeal
Br. 8-9.) We do not find this argument persuasive because we agree with
the Examiner that Rao teaches that it was known in the prior art that
magnetic particles and antibodies, i.e., the claimed first binding molecules,
can be bonded via a strong binding couple such as avidin/biotin or
streptavidin/biotin. (See Rao 12:16-32.) Appellants concede Rao discloses
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Application 12/299,806
a magnetic particle "is coated solely with avidin, while the coating on the
collection surface and the capture agent could comprise biotin." (Appeal Br.
8 (citing Rao 12: 16-19).) As the Examiner explains, this configuration of
the assay in Rao provides "a competing reaction of the binding pair member
on the magnetic particle with the binding pair member on the collection
surface." (Ans. 8 (citing Rao 12:48-52).) In other words, Rao teaches that
the avidin coated magnetic particle could combine with the biotin coated
antibody through avidin/biotin coupling.
Furthermore, whether Rao further teaches "immobilizing a magnetic
microparticle on a collection surface, by the coating of one member of a
specific binding pair to the collection surface" (Appeal Br. 8), does not
convince us that the claimed invention is non-obvious. "Non-obviousness
cannot be established by attacking references individually where the
rejection is based upon the teachings of a combination of references ....
[The reference] must be read, not in isolation, but for what it fairly teaches
in combination with the prior art as a whole." In re Merck & Co., 800 F.2d
1091, 1097 (Fed. Cir. 1986). While Rohr does not teach the first binding
molecule (e.g., an antibody) is bound to a magnetic particle via a strong
binding couple, as just discussed, Rao teaches that it was known in the art
that antibodies can be bound to magnetic particles via a strong binding
couple such as avidin (or streptavidin) biotin coupling.
Appellants contend the Examiner erred in asserting Rohr teaches
magnetic particles coated with both avidin and streptavidin and that this
coating is "a strong binding couple." (Appeal Br. 10.) We disagree with
Appellants interpretation of the Examiner's argument. The Examiner's use
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Application 12/299,806
of the forward slash in the phrase "avidin/streptavidin" in the statement
"Rohr teaches that magnetic particles can be coated with avidin/streptavidin
which is a member of a strong binding couple" (Adv. Act. 8) was not
intended to denote that Rohr' s magnetic particle was coated with the binding
couple avidin and streptavidin. Rather the forward slash in the context of
that statement was to denote Rohr teaches that a magnetic particle can be
coated with either avidin or streptavidin, both of which were known to be a
member or a strong binding couple where the second member of that couple
was biotin. That interpretation of Rohr is evidenced by at least the following
statements by the Examiner with respect to Rohr: "Rohr teaches coating
magnetic particles with avidin to detect biotin in the sample," and noting that
"avidin/biotin" and "streptavidin/biotin" are strong binding couples. (Final
Action 5; Adv. Act. 5.) The Examiner also notes that Rohr teaches "in
example 2 that magnetic particles are bound to streptavidin to form a
conjugate which is used to detect biotin in a sample" not that avidin is bound
to streptavidin to then bind biotin. (Ans. 9).
Appellants further contend that "there is no disclosure in either Rohr
[or] Rao, et al. that [avidin/streptavidin is a member of a strong binding
couple]." (Appeal Br. 10.) However, as discussed, the Examiner's rejection
did not rely on avidin/streptavidin as a strong binding couple, but rather that
both avidin and streptavidin were known as a member of a strong binding
couple with biotin. Appellants do not appear to challenge that point.
Moreover, as the Examiner notes, avidin/biotin coupling is well known in
the art as evidenced by Rao (Adv. Act. 9) and Appellants' specification
teaches "[t]he interaction between the protein avidin and the molecule biotin
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Application 12/299,806
is widely applied to link biological molecules to other moieties" (Spec.
8: 16-17) and that "a number of varieties of a vi din [are] commercially
available including streptavidin" (Spec. 8:20-21 ).
"The test for obviousness is not whether the features of a secondary
reference may be bodily incorporated into the structure of the primary
reference." In re Keller, 642 F.2d 413, 425 (CCPA 1981). The test is what
the combined teachings of the references would have suggested to those of
ordinary skill in the art. Id. Rohr' s teaching of magnetically assisted
binding assays is not solely directed to the first binding molecule being
streptavidin used to detect biotin. Rather, Rohr describes the use of any
"first binding molecule" that is an "analyte analog," including an antibody.
(See Final Action 4 (citing Rohr 15:13-34); Ans. 3 (citing Rohr 15:13-34).)6
As discussed above, Rao demonstrates that it was known that avidin can be
coated onto magnetic particles, as well as teaching that biotin coated
antibodies could bind to the avidin coated on magnetic particles. Moreover,
as the Examiner notes, and Appellants do not challenge, the avidin/biotin
binding pair is well known in the art for its high affinity binding
characteristics. (Ans. 4.) Thus, we agree with the Examiner that Rao
suggests to one of ordinary skill in the art that Rohr' s magnetically assisted
binding assays could employ avidin/biotin coupling to attach an antibody to
a magnetic particle, where the new antibody-biotin-avidin-magnetic particle
6 Although not specifically referred to by the Examiner, Rohr provides a list
of binding members suitable for use in the described binding assays, which
list includes immunoreactants, among other things, and provides an Example
in which magnetic particles are coated with antibody and then that entity is
used to bind to a second antibody. (Rohr 5:14--44, 24:14--51(Example4).)
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Application 12/299,806
entity would then be employed in binding a second binding molecule. (Final
Action 5; Adv. Act. 5, 8-9; Ans. 3--4, 8-9.)
We further note that Appellants have not asserted that the proposed
modification of Rohr in light of Rao' s teachings would have been beyond
the capabilities of a person of ordinary skill in the art. Moreover, Appellants
have pointed to no persuasive basis for concluding that the modification of
Rohr with Rao in this way is anything more than "predictable use of prior art
elements according to their established functions." KSR Int 'l Co. v. Teleflex
Inc., 550 U.S. 398, 417 (2007). "The combination of familiar elements
according to known methods is likely to be obvious when it does no more
than yield predictable results." Id.
For the reasons discussed, we affirm the Examiner's obviousness
rejection of claim 1 over Rohr and Rao.
Appellants contend that the method of claim 26 would not have been
obvious from Rohr and Rao for the same reasons advanced as to why claim
1 would not have been obvious. (Appeal Br. 11; Reply Br. 6.) For the
reasons discussed above, we disagree and affirm the Examiner's
obviousness rejection of claim 26 over Rohr and Rao.
Claims 4--10, 12, 19, and 31-35 have not been argued separately, and
therefore, fall with claims 1and26. 37 C.F.R. § 41.37(c)(l)(iv).
Claims 15-18 and 20
Appellants do not contest the Examiner's separate obviousness
rejection of claims 15-18 or claim 20 except for the reason that "the
additional prior art as specifically relied upon does not overcome the above
noted deficiencies" of the rejection as to claim 1. (Appeal Br. 11; Reply Br.
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6.) Because we affirm the Examiner's conclusion of obviousness of claim 1
over Rohr and Rao, we summarily affirm the rejections of claims 15-18 as
unpatentable over Rohr, Rao, and Henderson, as well as claim 20 as
unpatentable over Rohr, Rao, and Cubicciotti.
SUMMARY
We affirm the Examiner's rejection of
1. Claims 1, 4--10, 12, 19, 26, and 31-35 under 35 U.S.C. § 103(a) as
unpatentable over Rohr and Rao.
2. Claims 15-18 under 35 U.S.C. § 103(a) as unpatentable over Rohr,
Rao, and Henderson.
3. Claim 20 under 35 U.S.C. § 103(a) as unpatentable over Rohr,
Rao, and Cubicciotti.
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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