Ex Parte Karlsson et al

Patent Trial and Appeal Board

Sep 12, 2016

13499421 (P.T.A.B. Sep. 12, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/499,421 04/12/2012
826 7590 09/14/2016
ALSTON & BIRD LLP
BANK OF AMERICA PLAZA
101 SOUTH TRYON STREET, SUITE 4000
CHARLOTTE, NC 28280-4000
FIRST NAMED INVENTOR
Mathias Karlsson
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.
041013/416696 1055
EXAMINER
KINGAN, TIMOTHY G
ART UNIT PAPER NUMBER
1798
NOTIFICATION DATE DELIVERY MODE
09/14/2016 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):
usptomail@alston.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MATHIAS KARLSSON and SOFIA HIORT AF ORNAS 1
Appeal 2015-003664
Application 13/499 ,421
Technology Center 1700
Before BRADLEY R. GARRIS, CHUNG K. PAK, and
AVEL YN M. ROSS, Administrative Patent Judges.
GARRIS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134, Appellants appeal from the Examiner's
rejections under 35 U.S.C. § 103(a) of independent claim 1 as unpatentable
over Karlsson et al. (US 2008/0213744 Al, published Sept. 4, 2008)
("Karlsson") and dependent claims 56-74 as unpatentable over this
reference alone or in combination with additional prior art. We have
jurisdiction under 35 U.S.C. § 6.
1 Calmark Sweden Aktiebolag is identified as the real party in interest. App.
Br. 3.
Appeal2015-003664
Application 13/499,421
We AFFIRM.
Appellants claim a testing system comprising first and second
compartments for simultaneously detecting hemoglobin (Hb) and lactate
dehydrogenase (LDH) respectively and being arranged with chemical means
for such detection (claim 55, Fig. IA).
A copy of representative claim 55, taken from the Claims Appendix of
the Appeal Brief, appears below.
55. Testing system for assessing hypoxia induced cellular damage in
a mammal including human, said testing system comprising a disposable
device (2) with a sample inlet (4) and a collection chamber (32) arranged
with a separation device (3), wherein the collection chamber (32) is
connected to at least two, a first (5A) and a second (5B), visible detection
compartments for simultaneous detection, at least one of said first and
second visible detection compartments (5A, 5B) being arranged with
chemical means for direct detection, said first detection compartment (5A)
being arranged to determine whether the amount of hemoglobin (Hb) in a
sample of body fluid (9) from said mammal exceeds a predetermined level,
and said second detection compartment (5B) being arranged to evaluate
level of total amount of lactate dehydrogenase (LDH) in said sample by
means of said chemical means.
Appellants state that "only the patentability of independent Claim 55
is expressly argued herein" (App. Br. 7). Therefore, dependent claims 56-
7 4 will stand or fall with claim 5 5.
We sustain the rejections on appeal for the reasons given by the
Examiner and below.
In rejecting claim 55, the Examiner makes the following findings and
conclusion.
Karlsson does not specifically teach a detection
compartment arranged for determining hemoglobin. However,
Karlsson points out that hemolysis will cause an increase in
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Appeal2015-003664
Application 13/499,421
LDH, even if it is not by hypoxia, and that free hemoglobin
may be measured as an indicator of such hemolysis ([0015],
[0068]), integrating a marker for such event, preferably
hemoglobin, in the card [0085] (first and second detection
compartments for determining LDH and hemoglobin). Further,
Karlsson teaches the LDH testing system includes a
compartment with dry chemical means for visual detection
(Claims 48 and 54 of Karlsson). Accordingly, it would have
been obvious to one of ordinary skill in the art that a detection
chamber in the device of Karlsson be configured to include a
detection compartment for hemoglobin in addition to LDH in
order to provide an indication of the level of contribution by
hemolysis to LDH levels while measuring LDH at the same
time, according to the teaching of Karlsson, and in adjacent
compartments for ease of use and comparison, such
contribution being important and perhaps essential in forming
conclusions about hypoxia in the presence of high LDH levels.
Further, one of ordinary skill would have found desirable such
compartment for hemoglobin determination for analysis of
LDH in samples that are difficult to collect and have a higher
incidence of hemolysis.
(Final Action 4--5).
Appellants contest the Examiner's obviousness conclusion by arguing,
"while paragraph [0085] proposes that the exemplary card described in the
application may be modified to include a detector for detecting Hb as a
marker indicative ofhaemolysis, Karlsson does not provide any additional
information regarding how such a marker may be detected on the disposable
card" (App. Br. 10). In addition, Appellants state that "those of ordinary
skill in the art are readily aware that conventional measurements of Hb are
generally performed separately and subsequently (e.g., sequentially) to LDH
(and/or other marker-based) detections" (id.). According to Appellants, "the
Written Opinion received in corresponding PCT application
(PCT/SE2010/051048) conceded much as Appellants now argue, namely
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Appeal2015-003664
Application 13/499,421
that while Karlsson suggests that it is possible to get information about
haemolysis by measuring Hb, '[i]t is not shown how this is done"' (id. at
12).
Appellants' argument is not persuasive. As correctly pointed out by
the Examiner, "Karlsson ... teaches that ifhemolysis has occurred, plasma
LDH will increase, and that if there is indication that hemolysis is occurring
'frequently during sampling, it is foresome [(advantageous)] to integrate
[the] marker for haemolysis in the card', and that 'the most probable
scenario is that we will use free haemoglobin (Hb) as the marker of choice'
[0085]" (Final Action 2). This teaching of Karlsson vitiates the argument
under consideration. We emphasize that Appellants' argument is not
reinforced by their statement regarding conventional measurements of Hb
because this statement is not supported by evidence. Furthermore,
Appellants do not explain why the referenced Written Opinion in their PCT
application is relevant to the subject obviousness analysis under 35 U.S.C.
§ 103(a).
Appellants also contend "Karlsson 's disclosure of a card that may
include five detection cells (20A-20E) does not translate into a disclosure (or
a teaching or suggestion) that detection of various markers therein must
necessarily occur simultaneously" (App. Br. 10).
However, in presenting this contention, Appellants do not dispute or
otherwise address the Examiner's above quoted conclusion that it would
have been obvious to provide Karlsson with "adjacent compartments" (Final
Action 5) for detecting hemoglobin in addition to LDH. Such adjacent
compartments necessarily and inherently would be capable of detecting
hemoglobin and LDH simultaneously, like the corresponding adjacent
compartments shown in Appellants' Figure IA. For these reasons, the
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Appeal2015-003664
Application 13/499,421
record supports a determination that the adjacent compartments of
Karlsson' s modified system necessarily possess the capability "for
simultaneous detection" as recited in claim 55.
Finally, Appellants argue "[ n ]othing in Karlsson teaches or suggests
the incorporation of chemical reagents within any of its card or detection
cells may be used to detect Hb or other markers" (App. Br. 12).
As clarification, claim 55 recites "at least one of said first and second
visible detection compartments (5A, 5B) being arranged with chemical
means." Therefore, contrary to the implication of Appellants' argument, the
claim does not expressly require that a chemical reagent be incorporated
within a compartment or that the compartment in question is for detecting
hemoglobin specifically. The Examiner cites multiple disclosures in
Karlsson of compartments including the LDH compartment being arranged
with chemical means (Final Action 4--5 (citing Karlsson i-fi-1 50-51 as well as
claims 48 and 54), Ans. 11 (citing Karlsson i186)). Appellants do not
address these disclosures and therefore do not show error in the Examiner's
determination that the above quoted recitation does not patentably
distinguish claim 55 over Karlsson.
The decision of the Examiner is affirmed.
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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