Ex Parte Åkerström et al

Patent Trial and Appeal Board

Nov 6, 2018

13054188 (P.T.A.B. Nov. 6, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/054, 188 04/06/2011 Bo Akerstrom
22428 7590 11/08/2018
Foley & Lardner LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
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.
105454-0102
(028232-0127)
CONFIRMATION NO.
5138
EXAMINER
MARTINEZ, TARA L
ART UNIT PAPER NUMBER
1654
NOTIFICATION DATE DELIVERY MODE
11/08/2018 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BO AKERSTROM, STEP AN HANSON,
MARTIN LENNARTH OLSSON, and MAGNUS GRAM 1
Appeal2017-004993
Application 13/054, 188
Technology Center 1600
Before DONALD E. ADAMS, ERIC B. GRIMES, and RYAN H. FLAX,
Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims to a method of treating a subject using alpha-1-microglobulin (AIM).
The Examiner's rejections of claims 28-31, 35-37, and 39--43 under
35 U.S.C. §§ 102(b) and 103(a) are appealed. We have jurisdiction under
35 U.S.C. § 6(b).
We reverse.
1 The Real Party in Interest is identified as "AIM Pharma AB." Appeal Br.
3. We herein refer to the Specification of Jan. 14, 2011 ("Spec."); Final
Office Action of Dec. 1 7, 2015 ("Final Action"); Appeal Brief of May 12,
2016 ("Appeal Br."); Examiner's Answer of Dec. 12, 2016 ("Answer"); and
Reply Brief of Feb. 7, 2017 ("Reply Br."). Oral argument was heard on
November 1, 2018; a transcript of the hearing will be made a part of the
record on appeal.
Appeal2017-004993
Application 13/054,188
STATEMENT OF THE CASE
Independent claim 28, reproduced below, is representative:
28. A method of treating a subject suffering from a disease or
condition involving oxidative stress and reducing oxidant levels
in a subject in need thereof, the method comprising administering
to the subject an amount of alpha-1-microglobulin (AIM)
effective to reduce oxidant levels in the subject of from about 0.5
mg/kg to about 100 mg/kg, wherein the disease or condition
involving oxidative stress is selected from the group consisting
of sepsis, inflammation, arthritis, hemolytic transfusion reaction,
and diabetes.
Appeal Br. 21 (Claims Appendix). The other independent claim, claim 29,
is substantially similar to claim 28, except for being directed to "reducing
free haemoglobin levels in a subject" suffering from a disease or condition
associated with the presence of free haemoglobin, as opposed to "reducing
oxidant levels," however, both claims define the same group of "disease[s]
or condition[ s ]" to be treated.
The following rejections are on appeal:
Claims 28, 30, 31, and 39--43 stand rejected under 35 U.S.C. § I02(b)
as anticipated by Houston, 2 as evidenced by MGI. 3 Final Action 2.
Claim 29 stands rejected under 35 U.S.C. § I02(b) as anticipated by
Houston, as evidenced by COLA. 4 Id. at 6.
2 US 5,166,133 (issued Nov. 24, 1992) ("Houston").
3 MGI-Mouse Facts, http://www.informatics.jax.org/mgihome/other/ -
mouse_facts 1.shtml (last visited June 1, 2015) ("MGI").
4 COLA, Fast Facts 30, Complications of Blood Transfusion: Discussion
and Investigation (2006) ("COLA").
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Application 13/054,188
Claim 35 stands rejected under 35 U.S.C. § I03(a) over Houston and
Sadeghi. 5 Id. at 15.
Claims 36 and 37 stand rejected under 35 U.S.C. § I03(a) over
Houston, Sadeghi, and Terpe. 6 Id. at 17-18.
DISCUSSION
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting aprimafacie case ofunpatentability.
[Only once] that burden is met, the burden of coming forward with evidence
or argument shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445
(Fed. Cir. 1992).
"Anticipation requires that all of the claim elements and their
limitations are shown in a single prior art reference." In re Skvorecz, 580
F.3d 1262, 1266 (Fed. Cir. 2009). "The combination of familiar elements
according to known methods is likely to be obvious when it does no more
than yield predictable results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,
416 (2007). "[O]bviousness requires a suggestion of all limitations in a
claim." CFMT, Inc. v. Yieldup Int 'l Corp., 349 F.3d 1333, 1342 (Fed. Cir.
2003) (citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
Appellants argue the anticipation rejections together, focusing on the
Houston reference's alleged failings. The arguments presented by
Appellants over the obviousness rejections largely overlap their anticipation
arguments and they are also argued together by Appellants. Moreover, the
5 US 2007 /0060512 Al (published Mar. 15, 2007) ("Sadeghi").
6 K. Terpe, Overview of tag protein fusions: from molecular and
biochemical fundamentals to commercial systems, 60 APPL MICROBIOL
BIOTECHNOL 523-33 (2003) ("Terpe").
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Application 13/054,188
same findings of fact are determinative for all outstanding rejections.
Therefore, we address all rejections together.
The Examiner determined that claims 28, 30, 31, and 39-43 are
anticipated by Houston because the reference teaches administering the
claimed composition (i.e., "AIM"), at the claimed amount (i.e., 3 mg/kg,
which is within the claimed "about 0.5 mg/kg to about 100 mg/kg"), to the
claimed patient population (i.e., subjects needing treatment for sepsis,
inflammation, arthritis, and/or hemolytic transfusion reaction), and that the
physiological results of such administering, i.e., reducing oxidant levels,
would inherently occur. See Final Action 2-15, 20-22 and Answer 2-7, 12-
26 (citing Houston abstract, 1:54--58, 2:14--27, 2:41--48, 11:14--17, 11:20-
68, 18:56-19: 13 (Example 6, Table 8), claims 1, 5, 7; generally MGI
(laboratory mouse "[g]eneral [b Jody weight: average - 20 g; highly
variable")). Regarding claim 29, the Examiner made the same
determinations concerning Houston, but also cited COLA as evidence that
blood transfusions cause acute hemolytic transfusion reaction. Final Action
6. Regarding claim 35, the Examiner determined that the claim would have
been obvious over the combination of Houston and Sadeghi, relying on the
determinations concerning Houston set forth for the anticipation of the
independent claims and adding Sadeghi for its disclosure of specific claimed
AIM peptide sequences. See Answer 7-9. Similarly, regarding claims 36
and 3 7, the Examiner also relied on the determinations concerning
Houston's anticipation of the independent claims, combined with Sadeghi's
teachings as for claim 35, and added Terpe for its disclosure of ways to
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Application 13/054,188
modify AIM by adding a histidine tag and a factor X cleavage site. Id. at
10-11.
Appellants present a persuasive argument, which is that Houston does
not disclose administering from about 0.5 mg/kg to about 100 mg/kg of
AIM to a subject in need, as claimed. Appeal Br. 15-16.
Although Appellants do not contest the Examiner's math or factual
determinations concerning the dosage of Houston's Example 6 (i.e., that a
mouse has a mass of about 20g and administering 60 µg of a therapeutic
formulation to a 20g animal results in a dose of 3 mg/kg), we note that
Houston's relevant disclosure is not so straightforward. Houston's Example
6 indicates that "[f]our compositions were administered i.p. to mice: 1.5%
thioglycollate (TG) alone; 1.5% thioglycollate and a peptide from the CD 18
adhesion molecule called 4-29 (as a positive control); 1.5% thioglycollate
and a peptide from an oncogene called JUN (as a negative control); and
1.5% thioglycollate and a 1-M." Houston 18:56-66. Houston then discloses
that this last formulation of 1.5% thioglycollate and AIM was administered
to a mouse at a dose of 60 µg, which is the relevant disclosure cited by the
Examiner in rejecting the claims.
The problem we find with this determination by the Examiner is that
the claims require "administering to the subject an amount of alpha-1-
microglobulin (AIM) effective to reduce oxidant levels in the subject of
from about 0.5 mg/kg to about 100 mg/kg" (emphasis added), but the
disclosure of Houston does not specify how much of the 60 µg administered
to the mouse was actually AIM as compared to thioglycollate (or some other
component). See Appeal Br. 21 (Claims Appendix). We find no analysis by
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the Examiner that accounts for the amount of components in Houston's
compositions. Thus, it is not possible to know, based on the Examiner's
analysis, whether the claims are anticipated by such a disclosure or,
relatedly, would have been obvious thereover. For this reason, we must find
the Examiner has not established a prima facie case for either anticipation or
obviousness.
SUMMARY
The anticipation and obviousness rejections are each reversed.
REVERSED
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