Ex Parte Brocia

Patent Trial and Appeal Board

Apr 28, 2017

13754429 (P.T.A.B. Apr. 28, 2017)

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.
13/754,429 01/30/2013 Robert W. BROCIA 527832000700 8780
25225 7590 05/02/2017
MORRTSON fr FOFRSTFR T T P
EXAMINER
12531 HIGH BLUFF DRIVE MARCSISIN, ELLEN JEAN
SUITE 100
SAN DIEGO, CA 92130-2040 ART UNIT PAPER NUMBER
1678
NOTIFICATION DATE DELIVERY MODE
05/02/2017 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):
PatentDocket @ mofo. com
EOfficeSD @ mofo.com
pair_mofo @ firsttofile. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT W. BROCIA
Appeal 2015-002737
Application 13/754,429
Technology Center 1600
Before CHRISTOPHER G. PAULRAJ, TAWEN CHANG, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
PAULRAJ, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a kit for
measuring enzyme activity. The Examiner rejected the claims as
anticipated, or in the alternative, as obvious. We have jurisdiction under 35
U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Background
According to the Specification, “[t]he invention is in the field of
diagnostic assays, in particular the assessment of enzyme activity, for
1 Appellant identifies the Real Party in Interest as Roar Holding LLC. See
Appeal Br. 1.
Appeal 2015-002737
Application 13/754,429
example, cholesteryl ester transfer protein (CETP) activity, in bodily fluids.”
Spec. 12. In particular, “[t]he invention is an improved method to
determine enzyme activity in a sample of bodily fluid from a test subject
without dilution of the sample.” Id. 13. The Specification recognizes that
dilution of a sample “disrupts the physiological concentration of other
components” that “may have an effect on the enzyme activity directly or
indirectly.” Id. 13. As such, an improved assay according to the invention
can be achieved “by employing, as a negative control, a duplicate reaction
mixture, but with the addition of an effective amount of an inhibitor for the
enzyme.” Id. 110. “The neutralized sample is a more appropriate assay
blank than buffer, for example, because any matrix effects occurring in the
sample are subtracted out when the signal, such as fluorescence intensity, of
the neutralized control is subtracted from the signal of the active sample,”
and “[t]he result is a more accurate measurement of transfer than utilizing a
buffer.” Id. 118.
The Claims
Claims 10-15 are under appeal, and are reproduced in the Claims
Appendix of the Appeal Brief. Appellants have not argued the claims
separately, so we choose independent claim 10 as representative for our
analysis. The remaining claims stand or fall with claim 10. 37 C.F.R.
§ 41.37(c)(l)(iv); see also In re McDaniel, 293 F.3d 1379, 1383 (Fed. Cir.
2002) (“[T]he Board is free to select a single claim from each group of
claims subject to a common ground of rejection as representative of all
claims in that group and to decide the appeal of that rejection based solely
on the selected representative claim” in the absence of a clear statement
asserting separate patentability of the claims). Claim 10 reads as follows:
2
Appeal 2015-002737
Application 13/754,429
10. A kit for conducting an improved method to
measure the level of activity of an enzyme which kit comprises:
one or more containers containing substrate for said
enzyme whose level of activity is to be measured;
a container containing reagents for detection of the activity
of said enzyme; and
a container containing a deactivating agent or binding
agent for said enzyme.
Appeal Br. 7 (Claims App’x).
The Rejection
The Examiner has rejected claims 10-15 under 35 U.S.C. § 102(b) as
anticipated by or, in the alternative, under 35 U.S.C. § 103(a) as obvious
over Brocia.2
DISCUSSION
The Examiner finds:
Although Brocia (2007) teaches all the same compositions
as the claimed invention; and teaches that the invention includes
all of the steps, features, compositions and compounds referred
to or indicated in the specification; and teaches at col. 14, lines
27—22, that the components of the invention can be provided in
the form of a kit', Brocia (2007) does not explicitly teach all of
the components as individually contained in separate containers.
Rather, Brocia mentions the components contemplated in
containers, and then also exemplifies in stepwise fashion where
the components/reagents are added in sequential order (e.g. col.
5, line 41-adding components to the buffer, and col. 15, lines 31—
32, pre-treating with inhibitory monoclonal antibody).
Ans. 5.
2 Brocia, U.S. Patent No. 7,279,297 B2 (issued Oct. 9, 2007).
3
Appeal 2015-002737
Application 13/754,429
Based on the foregoing, the Examiner concludes that the skilled
artisan “would have at once envisaged a kit containing the three recited
reagents (all taught by Brocia) and reagents each being provided in separate
containers, given that the reference exemplifies that the reagents are added
sequentially at different time points.” Id. Likewise, the Examiner concludes
that “containers for all reagents would have been at once envisaged by the
ordinary artisan, particularly as the reagents are liquids.” Id. at 6.
In the alternative, the Examiner contends that the claimed invention
would have been obvious because the skilled artisan “would have been
motivated to provide the necessary reagents in kit form in separate
containers ... in order to simplify, facilitate determination of, and quantity
risk factors,” and further contends that there would have been a reasonable
expectation of success “because the advantages of packaging reagents
together in kit form were well known in the art at the time of the invention.”
Id. at 5—6.
Appellant acknowledges that the “the three containers required to be
in the kit are disclosed (sometimes inherently) at various places in Brocia.”
Appeal Br. 3. Appellant argues, however, that there is no suggestion in
Brocia that the containers be compiled together into a kit, and that “[t]he use
of a binding agent for CETP in Brocia is only to demonstrate that inhibitors
already present in a bodily fluid would indeed interfere with the assay as
performed in Brocia (which uses a buffer as a negative control).” Id.
[UJnless a prior art reference discloses within the four comers of the
document not only all of the limitations claimed but also all of the
limitations arranged or combined in the same way as recited in the claim, it
cannot be said to prove prior invention of the thing claimed and, thus, cannot
4
Appeal 2015-002737
Application 13/754,429
anticipate under 35 U.S.C. § 102.” Net MoneyIN, Inc. v. VeriSign, Inc.,
545 F.3d 1359, 1371 (Fed. Cir. 2008). We determine that Brocia does not
anticipate claim 10 as it does not teach the inclusion of all three recited
containers as part of a single kit. In this regard, we agree with Appellant that
the term “kit” recited in the preamble is a meaningful limitation as it
imposes a structural requirement on how the claimed containers must be
kept together. Reply Br. 2—3.
Nonetheless, we determine that claim 10 is rendered obvious based on
Brocia’s teaching that “[t]he components useful in the invention can be
provided in the form of a kit.” Brocia, 14:27—28. With regard to
obviousness, Appellant argues that “there is no suggestion in Brocia that
[inhibitors] be used as a negative control in order to provide comparable
samples in both the control and test assay mixture,” and “[i]t is only for this
reason that a container with an inhibitor would be included in a kit.” Appeal
Br. 5. It is undisputed, however, that Brocia teaches the use of CETP
inhibitors as a component for its invention. Brocia, 3:25—40. In Example 5,
Brocia teaches that the human plasma was “pre-treated with a CETP
inhibitory monoclonal antibody.” Id. at 15:30—32. Based on these
disclosures, we find that it would have been obvious to include a CETP
inhibitor, along with other necessary reagents and a substrate taught by
Brocia, as part of a kit. The fact that Appellant may have discovered a new
use for the inhibitor (i.e., as a negative control) does not render claim 10
patentable over Brocia. See Cross Med. Prods., Inc. v. Medtronic Sofamor
Danek, Inc., 424 F.3d 1293, 1323 (Fed. Cir. 2005) (“One of ordinary skill in
the art need not see the identical problem addressed in a prior art reference
to be motivated to apply its teachings.”).
5
Appeal 2015-002737
Application 13/754,429
Accordingly, we determine that claim 10 is obvious over Brocia.
Claims 11—15 fall with claim 10.
SUMMARY
We reverse the rejection of claims 10—15 under 35 U.S.C. § 102(b) as
being anticipated by Brocia.
We affirm the rejection of claims 10-15 under 35 U.S.C. § 103(a) as
being unpatentable over Brocia.
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
6