Ex Parte Zikria et al

Board of Patent Appeals and Interferences

Feb 9, 2011

11213303 (B.P.A.I. Feb. 9, 2011)

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.
11/213,303 08/29/2005 Bashir A. Zikria 9034
43399 7590 02/10/2011
EVELYN M. SOMMER
570 LEXINGTON AVENUE , 17TH FLOOR
NEW YORK, NY 10022
EXAMINER
OLSON, ERIC
ART UNIT PAPER NUMBER
1623
MAIL DATE DELIVERY MODE
02/10/2011 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte BASHIR A. ZIKRIA and JEMAL DEAN ZIKRIA
__________

Appeal 2010-010313
Application 11/213,303
Technology Center 1600
__________

Before ERIC GRIMES, MELANIE L. McCOLLUM, and STEPHEN
WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of treating a human subject and a composition for treating the
subject. The Patent Examiner issued a final rejection of all the claims. We
have jurisdiction under 35 U.S.C. § 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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STATEMENT OF THE CASE
“[T]his invention relates to macromolecules and biochemical methods
for preventing leakage of macromolecules from capillary endothelial
junctions during a period of increased capillary permeability secondary to
burn injury, battlefield injury, cytotoxicity, trauma, septic and hemorrhagic
shock, ischemia and other toxic processes while simultaneously preventing
pathology due to the activity of free radicals.” (Spec. 1.)
Claims 1-11 and 13-31, which are all the pending claims, are on
appeal. A copy of the claims on appeal may be found in Appellants’ Brief at
19-26. Briefly, method claims define a method of administering an effective
amount of a composition comprising at least one polysaccharide selected
from a list of three, and at least one active agent selected from a list of about
three dozen named agents or kinds of agents. (E.g., claim 1, App. Br. 19.)
Composition claims define compositions comprising a polysaccharide
selected from a list of three and an active agent selected from a list of about
three dozen named agents or kinds of agents. (E.g., claim 23, App. Br. 23.)
The Examiner rejected all the claims under 35 U.S.C. § 112 for lack
of enablement, and rejected all the claims over prior art in several rejections
grouping different claims under §§ 102(b) and 103. We reverse the rejection
for lack of enablement, and affirm the rejections for anticipation and
obviousness.
ENABLEMENT
The Examiner rejected claims 1-11 and 13-31 under 35 U.S.C. § 112,
first paragraph, “because the specification, while being enabling for methods
and compositions for treating or reducing leakage of serum proteins from
capillary endothelial junctions, does not reasonably provide enablement for a
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method of prevention or prophylaxis of said condition.” (Ans. 5-9.)
Appellants dispute the Examiner’s claim interpretation, and contend that
“the term ‘prevent’ is used in the sense of a method of treatment of human
subjects to prevent leakage of molecules, not for the life of the subject but to
inhibit capillary leakage and inflammatory changes before the trauma has
occurred (before surgery) or to correct or reduce the leakage after the trauma
has occurred (after a burn).” (App. Br. 7-8.)
The claims define a “[m]ethod of treating a human subject to prevent
leakage of serum proteins from capillary endothelial junctions . . . during a
period of increased capillary permeability which comprises administering to
a subject in need of such treatment . . . .” (Claim 1.) The defined method
treats a subject “in need of such treatment.” The rejection agrees that
treating or reducing leakage is enabled, or, put another way, preventing
further leakage during the period of increased permeability is enabled, as is
reducing the leakage from the level occurring prior to treatment. To the
extent the rejection concerns “prophylaxis” in the sense of preventing leaky
junctions from developing, that concern is misdirected because the claim
does not purport to prevent leaky junctions from developing.
We have reviewed the rejection’s analysis of the Wands factors (Ans.
5-9) but find it misdirected in that it concerns “prevention of a disease,”
which is not the method defined in the claims. For example, the rejection
directs its analysis to discussing “preventing disease” or “prevention of a
disease,” and finds that “prevention in the sense used herein must be capable
of stopping any occurrence of a condition at any time in the future.” (See,
e.g., Ans. 6, 8.) However, the method defined in the claims is “to prevent
leakage . . . during a period of increased capillary permeability which
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comprises administering to a subject in need of such treatment . . . .” (Claim
1.) The rejection does not show that a person of ordinary skill in the art
would reasonably interpret “[m]ethod of treating . . . a subject in need of
such treatment” to mean the method purports to stop “any occurrence of a
condition at any time in the future.” We find that the rejection analyzed a
method that is not claimed, and conclude that it did not establish a prima
facie case of nonenablement for the method that is claimed.
APPELLANTS’ CLAIM FOR THE BENEFIT OF
AN EARLIER FILING DATE
The effective filing date of the appealed claims is disputed. We
address this issue before reviewing the rejections under §§ 102 and 103
because Appellants intend their argument to disqualify some of the
references the Examiner used as evidence to support several of the
rejections.
The Issue
This Application was filed Aug. 29, 2005, as a continuation-in-part of
an application filed April 22, 1997. The Examiner determined that the
appealed claims are not entitled to the 1997 date, “as the parent application
fails to provide support under 35 USC 112, first paragraph[, for] a method or
composition involving any of the second active agents recited in instant
claim 1.” (Final Rej. 2.) The Examiner found that “though the parent
application offers support for the inclusion of generic antioxidants in the
disclosed method, it does not provide support for the many specific
compounds recited in the instant claims.” (Id.) That is, “the few examples
[listing six named compounds] given in the parent application are not
sufficiently representative of the full scope of the invention to provide
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written description for all of the individual species recited in the instant
claims.” (Id. at 2-3.)
Appellants agree that in comparison to the parent application, “the
instant application discloses additional antioxidants.” (App. Br. 6, citing
Spec. ¶ 9.) Appellants then state: “[i]t is submitted that it is the disclosure
of additional antioxidants and compositions containing them that constitutes
the added matter and that the basis for the same has been provided for in the
parent application. The applicant is entitled to claim priority as to this
common disclosure.” (Id. at 6-7.)
The issues to be decided are:
whether the Examiner made a prima facie case that the effective filing
date of the appealed claims is Aug. 29, 2005, the filing date of the instant
continuation-in-part application, not the April 22, 1997, filing date of the
parent application; and if so,
whether Appellants have rebutted the prima facie case by showing a
descriptive basis for the so-called “added matter” in the parent application
filed April 22, 1997.
Principles of Law
“[A] patent application is entitled to the benefit of the filing date of an
earlier filed application only if the disclosure of the earlier application
provides support for the claims of the later application, as required by
35 U.S.C. § 112.” In re Chu, 66 F.3d 292, 297 (Fed. Cir. 1995). When a
patent or an application claims the benefit of an earlier filed application, the
fact finder “must determine if one skilled in the art, reading the original
specification, would immediately discern the limitation at issue . . . .”
Waldemar Link, GmbH & Co. v. Osteonics Corp., 32 F.3d 556, 558-59 (Fed.
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Cir. 1994). “In other words, does the ‘disclosure of the application relied
upon reasonably convey to the artisan that the inventor had possession at
that time of the later claimed subject matter?’” Id., citation omitted.
An Examiner may meet “the initial burden of presenting evidence or
reasons why persons skilled in the art would not recognize in the disclosure
a description of the invention defined by the claims” by pointing out
differences between what is disclosed in the priority application and what is
now claimed. In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989) (affirming
a finding that the two chemical species disclosed in a foreign priority
application were insufficient written description to support the genus claims
of the corresponding U.S. application). “The applicant for a United States
patent bears the burden of establishing its entitlement to the filing date of a
previously filed application.” In re Ziegler, 992 F.2d 1197, 1200 (Fed. Cir.
1993).
Analysis
Appellants agree with the Examiner that antioxidants and
compositions disclosed and claimed in this CIP application did not appear in
the parent application. We also agree with the Examiner and therefore find
the Examiner met the burden of establishing a prima facie case for holding
that the appealed claims have an effective filing date of Aug. 29, 2005, the
filing date of this Application, and not of April 22, 1997, the filing date of
the parent application. See Gosteli, 872 F.2d at 1012.
Rather than offer evidence or an explanation showing that a person of
ordinary skill in the art, reading the parent application, would immediately
discern the additional antioxidants and compositions listed in the currently
appealed claims, Appellants simply state “the basis for the same has been
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provided for in the parent application.” (App. Br. 6-7.) We find this
conclusory allegation insufficient to rebut the prima facie case because it is
neither evidence nor explanation sufficient to show that one skilled in the
art, reading the parent specification, would immediately discern the
limitations at issue in the appealed claims. See Waldemar Link, 32 F.3d at
558-59.
We also find Appellants’ statement that they are entitled to claim
priority “as to this common disclosure” obscure because it does not explain
what “this common disclosure” means. If it refers only to the six
compounds the Examiner identified in the parent application that is not
disputed. But Claim 1, for example, lists dozens of compounds, and there is
no showing that the six compounds making up the common disclosure
support the dozens now recited in the claim.
We affirm the Examiner’s filing date determination. We thus agree
with the Examiner that the references relied on under §§ 102 and 103 were
available as evidence of the prior art as of April 29, 2005, the effective filing
date of the appealed claims.
ANTICIPATION
The Examiner’s position is that claims 1, 2, 4, 5, 11, 17-19, 23 and 24
were anticipated under 35 U.S.C. § 102(b) by Davis.2 The Examiner gave a
detailed summary of Davis’ disclosure, which taught administering
compositions to reperfuse an ischemic limb. (Ans. 10-11.) The evidence
supports the Examiner’s findings, and we adopt them as our own.

2 Scott Davis, WO 00/69427, published Nov. 23, 2000.
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Appellants contend that “[i]n complete contrast, the compositions of
the invention are introduced by a conventional I.V. delivery to prevent or
inhibit capillary leakage and inflammatory changes before the trauma has
occurred or to correct or reduce the leakage and inflammatory damages after
the trauma has occurred.” (App. Br. 11.) Appellants argue that an easily
oxidizable energy substrate is an important component of the Davis
composition, but that it is not necessary or required in their own claims.
(Id.) Appellants did not argue any claim in particular, and we select claim 1
as representative. Claims 2, 4, 5, 11, 17-19, 23 and 24 were not argued
separately and therefore stand or fall with claim 1. 37 C.F.R.
§ 41.37(c)(1)(vii).
The Examiner responds that “the rejected method claims do not
contain any limitation which would exclude the method described by
Davis,” and, with regard to the composition claims, the intended use of a
composition does not limit the claims. (Ans. 33-34.) We agree. The
claimed method does not require intravenous administration, nor have
Appellants identified another step to distinguish Davis’ method. The
Examiner is correct that an intended use recited in a claim does not
distinguish the claimed composition from the same composition described in
the prior art. Finally, Appellants’ claims define the composition with the
transitional term “comprising,” which means the claim is open to the
inclusion of unrecited components, including an easily oxidizable energy
substrate that Appellants argue is a component of Davis’ composition. As
the rejection under § 102 is supported by the evidence, we affirm it.

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OBVIOUSNESS
Principles of Law
“It is prima facie obvious to combine two compositions each of which
is taught by the prior art to be useful for the same purpose, in order to form a
third composition which is to be used for the very same purpose.” In re
Kerkhoven, 626 F.2d 846, 850 (CCPA 1980); Merck & Co., Inc. v. Biocraft
Labs, Inc., 874 F.2d 804, 809 (Fed. Cir. 1989) (“Given the prior art teaching
that both amiloride and hydrochlorothiazide are natriuretic, it is to be
expected that their co-administration would induce more sodium excretion
than would either diuretic alone”); In re Diamond, 360 F.2d 214, 217
(CCPA 1966) (where the evidence showed that synergy was expected
because combined drugs targeted different cellular mechanisms, and no
evidence to the contrary was produced, “[w]e are not convinced of non-
obviousness of the combination of the two drugs, A5MP and a
glucocorticoid . . . particularly since the record supports the [PTO’s]
contention that the drugs selected are two of the commonly used drugs in the
treatment of such collagen diseases”). See also, Princeton Biochemicals,
Inc. v. Beckman Coulter, Inc., 411 F.3d 1332, 1338-1339 (Fed. Cir. 2005)
(affirming obviousness where motivation was found in the knowledge of
those skilled in the art at the time, and where the nature of the problem also
supplied a motivation); DyStar Textilfarben GmbH & Co. Deutschland KG
v. C.H. Patrick Co., 464 F.3d 1356, 1366 (Fed. Cir. 2006) (“the ‘evidence’
of motive will likely consist of an explanation of the well-known principle
or problem-solving strategy to be applied”).
“[I]t is not necessary in order to establish a prima facie case of
obviousness…. that there be a suggestion in or expectation from the prior art
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that the claimed compound or composition will have the same or a similar
utility as one newly discovered by applicant.” In re Dillon, 919 F.2d 688,
693 (Fed. Cir. 1990) (emphasis in original).
“A reference is reasonably pertinent if, even though it may be in a
different field from that of the inventor’s endeavor, it is one which, because
of the matter with which it deals, logically would have commended itself to
an inventor’s attention in considering his problem.” In re Clay, 966 F.2d
656, 659 (Fed. Cir. 1992).

Claims grouped with claim 1 will stand or fall with claim 1.
For each rejection that grouped claims together, Appellants did not
argue any claims separately. For those rejections, we select claim 1 as
representative, and the other claims in the group will stand or fall will claim
1. See 37 C.F.R. § 41.37(c)(1)(vii).
A. The rejection of claims 25-29 under 35 U.S.C. § 103(a) as
unpatentable over Davis. (Ans. 11-12.)
Appellants did not request review of this rejection, and did not
mention it in their Brief. (App. Br. 5, listing grounds of rejection to be
reviewed, not including this rejection.) Appellants thus have waived their
right for further appellate review of this rejection. We therefore do not
review the rejection.
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B. The rejection of claims 1, 13, 18-21, 23, 25 and 27-31 under
35 U.S.C. § 103(a) as unpatentable over Zikria,3 and Simpkins.4 (Ans. 12-
14.)
The Examiner gave a detailed summary of the Zikria and Simpkins
disclosures, and found they taught administering compositions comprising
hydroxyethyl starch and estrogen compounds, respectively, to treat ischemic
damage. The Examiner found that “[o]ne of ordinary skill in the art would
have recognized that these two therapies were both useful for treating
ischemic damage in a subject, and would therefore have been motivated to
coadminister them, either as two separate compositions or as one combined
pharmaceutical composition. Combining two therapies known in the prior
art is well within the ordinary and routine level of skill in the art.” (Ans.
13.) The evidence supports the Examiner’s findings and we adopt them as
our own.
Appellants do not dispute the Examiner’s finding that treating
ischemia would inherently prevent leakage, but contend “[t]here is no
suggestion or motivation from the references to make the modification
suggested by the Examiner.” (App. Br. 12.)
The Examiner responds that the motivation to modify a reference may
be for a different purpose than the inventor’s purpose, in this case, the
general problem of treating ischemic damage rather than the specific
problem of leakage that Appellants addressed. (Ans. 35, citing authority.)
The Examiner’s position is consistent with precedent. E.g., Dillon, 919 F.2d
at 693. Further, “[c]onsidering that Simpkins discloses treating the same

3 Bashir A. Zikria, US 4,994,444, issued Feb. 19, 1991.
4 James W. Simpkins, US 5,877,169, issued Mar. 2, 1999.
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conditions as Zikria, one of ordinary skill in the art would have had a clear
motivation to combine and co-administer them in the expectation of an
additive benefit.” (Ans. 35.) In our view, the Examiner’s original finding of
motivation, and the reasoning in the response, are supported by the evidence
and consistent with precedent. See Kerkhoven, 626 F.2d at 850; Merck &
Co., 874 F.2d at 809; Diamond, 360 F.2d at 217. We therefore affirm the
rejection.
C. The rejection of claims 1, 13, and 17-31 under 35 U.S.C. § 103(a) as
unpatentable over Oz,5 and Simpkins. (Ans. 14-16.)
The Examiner gave a detailed summary of the Oz and Simpkins
disclosures, and found they taught administering compositions comprising
superoxide dismutase with hydroxyethyl starch and estrogen compounds,
respectively, to treat ischemic damage. The Examiner found that “[o]ne of
ordinary skill in the art would have recognized that these two therapies were
both useful for treating ischemic damage in a subject, and would have
therefore been motivated to coadminister them, either as two separate
compositions or as one combined pharmaceutical composition. Combining
two therapies known in the prior art is well within the ordinary and routine
level of skill in the art.” (Ans. 15.) The evidence supports the Examiner’s
findings and reasoning, and we adopt them as our own.
Appellants contend that “the use of estrogen in Simpkins is
duplicative of the use of HES and SOD in Oz. There would be no need to

5 Mehmet C. Oz et al., Hydroxyethyl Starch Macromolecule and Superoxide
Dismutase Effects on Myocardial Reperfusion Injury, 162 AMER. J.
SURGERY 59-62 (1991).
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add estrogen, certainly no suggestion or teaching that it could function as an
antioxidant and be of any advantage to the combination.” (App. Br. 13.)
The Examiner responds that “it is ordinary and routine in the art to
combine two existing therapeutic compositions or methods in order to
achieve an additive effect that is greater than that produced by either one of
the compositions alone.” (Ans. 36.) The Examiner also responded that
because Oz showed a method improved over a control “but not perfectly
efficacious,” a further improvement would have been expected by adding
estrogen to Oz’s composition and method. (Id.)
Appellants have not identified evidence in the prior art to support their
contention that the use of estrogen is duplicative. More importantly, they
have not identified evidence showing that those of ordinary skill in the art
would have considered that estrogen use was duplicative or redundant of
HES and SOD. In the absence of such evidence, we think the Examiner has
the better account of the facts. The rejection is also consistent with the law.
See Kerkhoven, 626 F.2d at 850; Merck & Co., 874 F.2d at 809; Diamond,
360 F.2d at 217. We therefore affirm the rejection.
D. The rejection of claims 1, 7, 8, 18-21, 23, 25, and 27-31 under
35 U.S.C. § 103(a) as unpatentable over Zikria, and Bouskela.6 (Ans. 16-
18.)
The Examiner gave a detailed summary of the Zikria and Bouskela
disclosures and concluded that “[i]t would have been obvious . . . to add the

6 Eliete Bouskela et al., Effects of Oral Administration of Purified
Micronized Flavonoid Fraction on Increased Microvascular Permeability
Induced by Various Agents and on Ischemia/Reperfusion in Diabetic
Hamsters, 15 INT. J. MICROCIRC. 293-300 (1995).
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flavonoid composition of Bouskela to the treatment described by Zikria.”
(Ans. 17.) The evidence supports the Examiner’s findings and we adopt
them as our own.
Appellants contend that the “Bouskela reference is specific to the oral
administration of a micronized flavonoid . . . .” (App. Br. 13.) According to
Appellants, there is no motivation or suggestion to use flavonoids
intravenously or to use them in addition to a macromolecule like HES.
(App. Br. 13.)
The Examiner responds that “oral and intravenous administration are
both routine, conventional, predictable methods for administering an active
agent and one of ordinary skill in the art would have had a reasonable
expectation of success in using a small molecule therapeutic such as a
flavonoid in either of these conventional methods.” (Ans. 37.)
Appellants’ argument about intravenous administration is directed to a
limitation that does not appear in the claims. Appellants provide no
evidence that the Examiner’s proposed combination would not have been
expected to work. The Examiner’s reasoning is consistent with precedent.
See Kerkhoven, 626 F.2d at 850; Merck & Co., 874 F.2d at 809; Diamond,
360 F.2d at 217. We therefore affirm the rejection.
E. The rejection of claims 1, 7, 8, and 17-31 under 35 U.S.C. § 103(a) as
unpatentable over Oz, and Bouskela. (Ans. 18-20.)
The Examiner gave a detailed summary of the Oz and Bouskela
disclosures and concluded that “[i]t would have been obvious . . . to add the
flavonoid composition of Bouskela to the treatment described by Oz.” (Ans.
19.) The evidence supports the Examiner’s findings.
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Appellants argue that this rejection should be reversed for the same
reasons presented against the rejection over Zikria and Bouskela (App. Br.
14.) We found those arguments unpersuasive, see item D, immediately
above, and find them unpersuasive here as well. We therefore affirm the
rejection.
F. The rejection of claim 16 under 35 U.S.C. § 103(a) as unpatentable
over Davis, and Faivre.7 (Ans. 20-21.) Claim 16 limits the polysaccharide-
conjugated hemoglobin of claim 1 to a member of a group including
dextran-conjugated hemoglobin.
The Examiner relied on the earlier findings concerning Davis’
teachings (see Ans. 10-11), and found that Davis did not teach using stroma-
free hemoglobin conjugated to dextran. (Ans. 20.) However, Faivre taught
using dextran-conjugated hemoglobin in a plasma substitute shown “to
provide improved survival of ischemic-reperfused bowel tissue as compared
to unmodified hemoglobin.” (Id.) The Examiner concluded that it would
have been obvious to use dextran-conjugated hemoglobin because Faivre
showed it was “especially useful for reperfusing ischemic tissue with
minimal damage.” (Id. at 21.) The evidence supports the Examiner’s
findings and we adopt them as our own.
Appellants contend that Faivre teaches that conjugated hemoglobin
has the capacity to release oxygen, but Appellants’ invention uses it as an
antioxidant. “The artisan would not look to Faivre . . . as Faivre’s teachings
would not result in applicant’s objectives.” (App. Br. 14.)

7 B. Faivre et al., Assessment Of Dextran 10-Benzene-Tetracarboxylate-
Hemoglobin, An Oxygen Carrier, Using Guinea Pig Isolated Bowel Model,
23 ART. CELLS, BLOOD SUBS., AND IMMOB. BIOTECH. 495-504 (1995).
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We agree with the Examiner that “[w]hether one of ordinary skill in
the art would have been motivated to practice the claimed method for the
same reason as Applicant or for a different reason is immaterial to a finding
of obviousness so long as the resulting method is the same.” (Ans. 37-38.)
Appellants’ distinction between the property emphasized by Appellants and
the property emphasized by Faivre does not persuade us of error. See
Dillon, 919 F.2d at 693. Although Appellants contend that Faivre’s
teachings would not result in Appellants’ objectives, Appellants provide no
evidence to support that argument. We are persuaded by the Examiner’s
reasoning that because Davis and Faivre both provided solutions to treating
ischemia using hemoglobin, and Faivre showed that dextran-conjugated
hemoglobin was superior to unmodified hemoglobin, a person of skill in the
art would have been motivated to use dextran-modified hemoglobin in
Davis’ method. We therefore affirm the rejection.
G. The rejection of claim 3 under 35 U.S.C. § 103(a) as unpatentable
over Davis, and Babish.8 (Ans. 21-22.) Claim 3 limits claim 1’s tocotrienol
to one selected from the group consisting of alpha-, beta-, gamma-, and
delta-tocotrienols.
The Examiner relied on the earlier findings concerning Davis’
teachings (see Ans. 10-11), and found that Davis did not disclose a method
or composition using the listed tocotrienols. (Ans. 21.) The Examiner found
that Babish disclosed “a composition having a synergistic inhibitory effect
on biological oxidation processe[s] involving free radicals or singlet oxygen,

8 John G. Babish et al., US 2002/0120001 A1, published Aug. 29, 2002.
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comprising a . . . tocotrienol” and disclosed using alpha-, beta-, gamma-, or
delta-tocotrienol. (Id.)
Appellants contend that “[t]he Babish composition is a dietary
supplement and is intended for oral, topical, transdermal, transmucosal or
parenteral routes.” “There is no teaching in Babish or Davis that would
motivate the skilled artisan to make the combination proposed by the
Examiner.” (App. Br. 15.)
The Examiner responds that “as discussed in the rejection, Davis
discloses the need for a radical scavenger. Because Babish discloses a
radical scavenger, one of ordinary skill in the art would clearly be motivated
to include this radical scavenger in the composition of Davis.” (Ans. 38.)
We agree with the Examiner’s reasoning because it is supported by
the evidence. Appellants characterize Babish’s composition as a dietary
supplement, but acknowledge that Babish taught administering the
composition parenterally. We cannot agree that Babish limited its method to
diet supplements. See, e.g., Babish claims 25-31. We find that the
Examiner provided evidence that Babish would have motivated a person
skilled in the art to use one of the recited tocotrienols in Davis’ method and
composition. We therefore affirm the rejection.
H. The rejection of claims 1, 14, 18-21, 23, 25, and 27-31 under
35 U.S.C. § 103(a) as unpatentable over Zikria, and Ogiso.9 (Ans. 22-24.)
The Examiner gave a detailed summary of the Zikria and Ogiso
disclosures and concluded that “[i]t would have been obvious . . . to add
putrescine as described by Ogiso et al. to the treatment described by Zikira.

9 Seiji Ogiso et al., The Role of Polyamines in Liver Regeneration After
Hepatectomy with Ischemic Injury, 27 JPN. J. SURG. 833-839 (1997).
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One of ordinary skill in the art would have recognized that putrescine is
useful for the same purpose, namely protecting against ischemic tissue
damage, and that [t]he combined composition would have improved utility
for the treatment of hepatic ischemia-reperfusion injury. Combining two
therapies known in the prior art is well within the ordinary and routine level
of skill in the art.” (Ans. 23.) The evidence supports the Examiner’s
findings and we adopt them as our own.
Appellants contend that Ogiso has nothing to do with preventing
leakage from capillary endothelial junctions while simultaneously
preventing damage to surrounding tissues. “[A]ny suggestion to make the
combination of reference teachings can only come from the application . . .
.” (App. Br. 16.)
The Examiner responds that “both references disclose methods for
treating or preventing ischemic tissue damage. Therefore one of ordinary
skill in the art would have been motivated to administer [the compositions]
together in order to achieve an additive effect.” (Ans. 38.) We agree with
the Examiner that the reason for combining the teachings of the prior art is
based in the prior art itself. The Examiner’s reasoning is consistent with
precedent. See Kerkhoven, 626 F.2d at 850; Merck & Co., 874 F.2d at 809;
Diamond, 360 F.2d at 217. The motivation to modify a known method may
be for a different purpose than the inventor’s purpose, in this case, the goal
of treating or preventing ischemic damage rather than the specific problem
of leakage that Appellants addressed. E.g., Dillon, 919 F.2d at 693. The
Examiner’s position is consistent with precedent. We therefore affirm the
rejection.
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I. The rejection of claims 1, 14, and 17-31 under 35 U.S.C. § 103(a) as
unpatentable over Oz and Ogiso. (Ans. 24-26.)
The Examiner gave a detailed summary of the Oz and Ogiso
disclosures and concluded that “[i]t would have been obvious . . . to add
putrescine as described by Ogiso et al. to the treatment described by Oz et al.
One of ordinary skill in the art would have recognized that putrescine is
useful for the same purpose, namely protecting against ischemic tissue
damage, and that [t]he combined composition would have improved utility
for the treatment of hepatic ischemia-reperfusion injury. Combining two
therapies known in the prior art is well within the ordinary and routine level
of skill in the art.” (Ans. 25.) The evidence supports the Examiner’s
findings and we adopt them as our own.
Appellants contend that “[n]either reference is related to the invention
directed at preventing capillary leakage by administering a macromolecule
(HES, glycogen, dextran) and an antioxidant.” (App. Br. 16.) “The artisan
would not make the combination as suggested by the Examiner without
knowing of what the applicants had done.” (App. Br. 17.)
The motivation to modify a known method may be for a different
purpose than the inventor’s purpose, in this case, the goal of treating or
preventing ischemic damage rather than the specific problem of leakage that
Appellants addressed. E.g., Dillon, 919 F.2d at 693. The Examiner’s
position is consistent with precedent. We therefore affirm the rejection.

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J. The rejection of claims 1, 6, 18-21, 23, 25, and 27-31 under 35 U.S.C.
§ 103(a) over Zikria and Hirashima.10 (Ans. 26-28.)
The Examiner gave a detailed summary of the Zikria and Hirashima
disclosures and concluded that “[i]t would have been obvious . . . to add the
selenoprotein of Hirashima et al. to the treatment described by Zikria. One
of ordinary skill in the art would have recognized that selenoprotein P as
described by Hirashima et al. is useful for the same purpose as the invention
of Zikria, namely protecting against ischemic tissue damage, and that [t]he
combined composition would have improved utility for the treatment of
ischemia-reperfusion injury. Combining two therapies known in the prior
art is well within the ordinary and routine level of skill in the art.” (Ans.
27.) The evidence supports the Examiner’s findings and we adopt them as
our own.
Appellants contend that the “there is no suggestion or motivation for
the modification in the references so as to approximate the applicant’s
invention but not with true success either as concerns the composition or the
method.” (App. Br. 17.)
We agree with the Examiner that the reason for combining the
teachings of the prior art is based in the prior art itself. The Examiner’s
reasoning is consistent with precedent. See Kerkhoven, 626 F.2d at 850;
Merck & Co., 874 F.2d at 809; Diamond, 360 F.2d at 217.

10 Hirashima et al., JP 2002-060346A, published Feb. 2002.
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K. The rejection of claims 1, 6, and 17-31 under 35 U.S.C. § 103(a) over
Oz, and Hirashima. (Ans. 28-29.)
The Examiner gave a detailed summary of the Oz and Hirashima
disclosures and concluded that “[i]t would have been obvious . . . to add the
selenoprotein of Hirashima et al. to the treatment described by Oz et al. One
of ordinary skill in the art would have recognized that selenoprotein P as
described by Hirashima et al. is useful for the same purpose as the invention
of Oz, namely protecting against ischemic tissue damage, and that [t]he
combined composition would have improved utility for the treatment of
ischemia-reperfusion injury. Combining two therapies known in the prior
art is well within the ordinary and routine level of skill in the art.” (Ans. 28-
29.) The evidence supports the Examiner’s findings and we adopt them as
our own.
Appellants contend that the “there is no suggestion or motivation for
the modification in the references so as to approximate the applicant’s
invention but not with true success either as concerns the composition or the
method.” (App. Br. 17.)
We agree with the Examiner that the reason for combining the
teachings of the prior art is based in the prior art itself. The Examiner’s
reasoning is consistent with precedent. See Kerkhoven, 626 F.2d at 850;
Merck & Co., 874 F.2d at 809; Diamond, 360 F.2d at 217.

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L. The rejection of claims 1, 5, 9, 10, 12, 19-21, 23, 25, and 27-31 under
35 U.S.C. § 103(a) as unpatentable over Feola,11 and Cliffton.12 (Ans. 29-
31.)
The Examiner found that Feola disclosed a blood substitute that
comprised cross-linked hemoglobin, dextran or hydroxyethyl starch, and an
electrolytic solution, but not including ellagic acid. (Ans. 30.) Cliffton
disclosed that ellagic acid induced hypercoaguability, and that it decreased
traumatic bleeding in rats after tail amputation. (Id.) The Examiner
concluded that it would have been obvious “to add ellagic acid to the blood
substitute of Feola et al.” because both compositions “are already useful for
administering to subjects suffering from traumatic bleeding, and are
therefore also useful in a composition for administration to a subject
suffering from traumatic bleeding that can both replace lost blood and
reduce further blood loss.” (Id.)
Appellants contend that “Feola teaches a blood substitute which is of
a very different composition with a very different objective than the
composition of the invention. Cliffton similarly has nothing to do with the
invention and is directed to the prevention of traumatic bleeding by ellagic
acid in animals.” (App. Br. 18.) “[T]he references are inappropriate and
their combination does not teach or suggest the invention as claimed.” (Id.)
Feola provided a composition said to be “effective in sustaining life
after severe hemorrhage.” (Feola, col. 1, ll. 15-19.) According to Feola,
severe hemorrhage endangers life because “the drop in circulating blood

11 Mario Feola et al., US 5,439,882, issued Aug. 8, 1995.
12 E.E. Cliffton et al., Prevention of Traumatic Bleeding by Ellagic Acid in
Rats, 120 PROC. SOC. EXP. BIO. MED. 179-180 (1965).
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volume reduces tissue perfusion and produces ischemia.” (Id. at col. 1, ll.
23-26.) Cliffton disclosed that “[i]ntravenous injection of ellagic acid causes
marked statistically significant decrease in bleeding after amputation of the
tail in the rat.” (Cliffton, Summary, 180.)
We cannot agree with Appellants’ contention that Feola’s treatment of
hemorrhage and ischemia had a very different objective than the invention.
As Appellants describe it, their own invention is directed to preventing
leakage during conditions associated with trauma, hemorrhagic shock, and
ischemia. (Spec. 1.) Feola was also directed at treating hemorrhage and
ischemia, and Cliffton was directed to reducing hemorrhage. We find that
the Feola and Cliffton teachings were reasonably combined for the reason
the Examiner stated. See Clay, 966 F.2d at 659. The motivation to modify a
known method may be for a different purpose than the inventor’s purpose, in
this case, Feola’s goal of treating or preventing ischemic damage rather than
the specific problem of leakage that Appellants addressed. E.g., Dillon, 919
F.2d at 693. If Cliffton’s ellagic acid had been added to Feola’s
composition, the result would have been the composition Appellants now
claim. We agree with the Examiner that the evidence supports concluding it
would have been obvious to do so, and it would have been obvious to use
the combined composition in Feola’s method, the method that Appellants
now claim.

SUMMARY
We reverse the rejection of claims 1-11 and 13-31 under 35 U.S.C.
§ 112, first paragraph.
We affirm the following rejections:
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claims 1, 2, 4, 5, 11, 17-19, 23 and 24 under 35 U.S.C. § 102(b) as
anticipated by Davis;
claims 1, 13, 18-21, 23, 25 and 27-31 under 35 U.S.C. § 103(a) as
unpatentable over Zikria and Simpkins;
claims 1, 13, and 17-31 under 35 U.S.C. § 103(a) as unpatentable over
Oz and Simpkins;
claims 1, 7, 8, 18-21, 23, 25, and 27-31 under 35 U.S.C. § 103(a) as
unpatentable over Zikria and Bouskela;
claims 1, 7, 8, and 17-31 under 35 U.S.C. § 103(a) as unpatentable
over Oz and Bouskela;
claim 16 under 35 U.S.C. § 103(a) as unpatentable over Davis and
Faivre;
claim 3 under 35 U.S.C. § 103(a) as unpatentable over Davis and
Babish;
claims 1, 14, 18-21, 23, 25, and 27-31 under 35 U.S.C. § 103(a) as
unpatentable over Zikria and Ogiso;
claims 1, 14, and 17-31 under 35 U.S.C. § 103(a) as unpatentable over
Oz and Ogiso;
claims 1, 6, 18-21, 23, 25, and 27-31 under 35 U.S.C. § 103(a) over
Zikria and Hirashima;
claims 1, 6, and 17-31 under 35 U.S.C. § 103(a) over Oz and
Hirashima; and
claims 1, 5, 9, 10, 12, 19-21, 23, 25, and 27-31 under 35 U.S.C.
§ 103(a) as unpatentable over Feola and Cliffton.

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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

alw

EVELYN M. SOMMER
570 LEXINGTON AVENUE , 17TH FLOOR
NEW YORK, NY 10022