Ex Parte Krebs et al

Board of Patent Appeals and Interferences

Sep 8, 2010

11243043 (B.P.A.I. Sep. 8, 2010)

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.
11/243,043 10/04/2005 Peter J. Krebs 39073/321328 7220
23370 7590 09/08/2010
JOHN S. PRATT, ESQ
KILPATRICK STOCKTON, LLP
1100 PEACHTREE STREET
SUITE 2800
ATLANTA, GA 30309
EXAMINER
THOMAS, TIMOTHY P
ART UNIT PAPER NUMBER
1628
MAIL DATE DELIVERY MODE
09/08/2010 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 PETER J. KREBS,
ALLISON KREBS-BENSCH, and JEROME W. MINCY
__________

Appeal 2010-003834
Application 11/243,043
Technology Center 1600
__________

Before ERIC GRIMES, LORA M. GREEN, and STEPHEN WALSH,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to an iron
supplement, which the Examiner has rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.

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.
Appeal 2010-003834
Application 11/243,043

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STATEMENT OF THE CASE
The Specification discloses that “[t]reatment of anemia … typically
involves administering iron supplements…. Ionic iron (ferrous) oral dosage
forms … are often used.” (Spec. 2.) “An alternative to ionic oral dosage
forms of iron is polysaccharide iron complex (PIC), which has been shown
to have equivalent efficacy at increasing hemoglobin and hematocrit values
as ferrous sulfate and/or ferrous fumarate, but is better tolerated” (id. at 3).
Claims 1, 2, 4, 8, and 9 are on appeal. Claims 1 and 2 are
representative and read as follows:
1. An orally administrable iron supplement composition for treatment
or prophylaxis of iron deficiency, comprising:
an effective amount of a pharmaceutically acceptable ferrous iron salt;
and
an effective amount of polysaccharide iron complex, wherein the
polysaccharide iron complex comprises from about 38 wt% to about 46 wt%
iron.

2. The composition of claim 1, wherein the amount of iron derived
from pharmaceutically acceptable ferrous iron salt is the same as the amount
of iron derived from polysaccharide iron complex.

Issue
The Examiner has rejected claims 1, 2, 4, 8, and 9 under 35 U.S.C.
§ 103(a) as being obvious in view of Liu.2 Claim 2 has been argued
separately; claims 4, 8 and 9 stand or fall with claim 1. 37 C.F.R.
§ 41.37(c)(1)(vii).

2 Liu et al., Comparison of a Combination Ferrous Fumarate Product and a
Polysaccharide Iron Complex as Oral Treatments of Iron Deficiency
Anemia: A Taiwanese Study, 80 INT.’L JOURNAL OF HEMATOLOGY 416-420
(2004)
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The Examiner finds that Liu discloses a clinical comparison “where a
ferrous fumarate iron supplement was compared with a ferric iron
polysaccharide complex (Niferex…)” (Answer 3). The Examiner finds that
Liu reports the ferrous product was significantly more effective in increasing
levels of hemoglobin, but caused more gastrointestinal side effects (id.).
The Examiner concludes that it “would have been obvious to one of ordinary
skill in the art … to combine the ferrous fumarate and PIC taught by Liu into
a single supplement” (id. at 3-4) because doing so “would be expected to
give [the] effective results (of the ferrous fumarate) and lower the
gastrointestinal side effects of the combination, compared to straight dosing
of the ferrous fumarate” (id. at 4).
Appellants contend that one of skill in the art would not have been
motivated to form a composition that contains both a ferrous salt and a PIC
because Liu’s results show that the two are not art-recognized equivalents
(Appeal Br. 10). Appellants also contend that Liu teaches away from
combining a ferrous salt and a PIC because it teaches that the ferrous salt is
significantly more effective than the PIC while causing comparable side
effects (id. at 15-16). Finally, Appellants contend that the Specification
shows that a combination of a ferrous salt and a PIC is unexpectedly
effective as an iron supplement (id. at 13-14), especially when combined in
equal amounts (id. at 17-18).
The issues presented are:
Does the evidence of record support the Examiner’s conclusion that
one of skill in the art would have considered it obvious to combine a ferrous
salt and a PIC in view of Liu? and, if so,
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Have Appellants provided evidence of unexpected results that, when
weighed with the evidence supporting the Examiner’s rejection, shows that
the claimed invention would not have been obvious?
Findings of Fact
1. Liu discloses that “[i]n vivo, iron readily and reversibly moves
between the ferrous (Fe2+) and ferric (Fe3+) oxidation states” (Liu 416, left
col.).
2. Liu discloses that “[f]errous salt preparations historically have
been effective treatments of iron deficiency anemia. However, these agents
also have been associated with more side effects than ferric preparations.…
On the other hand, iron is absorbed far less efficiently from ferric salts.”
(Id.)
3. Liu discloses treating iron anemia with either “a ferrous iron
supplement (Ferall, a combination of ferrous fumarate with ascorbic acid,
folic acid, and cyanocobalamin) or a ferric iron polysaccharide complex
(Niferex, ferro-glycine sulfate) plus ascorbic acid” (Liu, abstract).
4. Liu discloses that participants received either “Ferall, 1 capsule
daily (ferrous fumarate equivalent of 151 mg elemental iron … ) or Niferex,
1 capsule daily (ferro-glycine equivalent of 150 mg elemental iron)” (id. at
417).
5. Liu discloses that “[b]oth iron supplements … raised mean
hemoglobin level over the course of the 12-week study” (id. at 419).
6. Liu discloses that, in patients administered Niferex, “[h]emoglobin
concentration did not rise enough to reach the lower limit of the normal
range” (id.).
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7. Liu discloses that “hemoglobin concentration … rose into the
normal range for patients in the current study who took the ferrous
supplement” (id.)
8. Liu discloses that the “ferrous product was more effective but had
a higher level of reported GI side effects,” although it was “a marginal
difference in GI side effects …, mild-to-moderate nausea and diarrhea being
the problems more common among patients taking ferrous-based
supplementation” (id. at 420).
Analysis
Claim 1 is directed to an oral iron supplement composition comprising
a pharmaceutically acceptable ferrous iron salt and a polysaccharide iron
complex (PIC).3 Liu discloses treatment of anemia with either a ferrous iron
salt composition or a PIC, and concludes that both compositions raised mean
hemoglobin levels over the course of the study, and that the “ferrous product
was more effective but had a higher level of reported GI side effects” (FF 8).
We agree with the Examiner that, in view of these disclosures, it would have
been obvious to one of ordinary skill in the art to form an anemia treatment
composition comprising both a ferrous iron salt and a PIC to form a
composition that would adequately raise hemoglobin levels while
minimizing the nausea and diarrhea that were more common among patients
taking a ferrous-based supplement alone.

3 Claim 1 also requires that the PIC comprises about 38-46 wt% iron but
Appellants do not dispute the Examiner’s finding (Answer 3) that Liu’s
Niferex product meets this limitation.
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Appellants contend that one of skill in the art would not have
considered it obvious to combine a ferrous salt and a PIC in a single
composition because Liu discloses that the ferrous salt was more effective
than the PIC as a treatment for anemia and therefore the two are not art-
recognized equivalents (Appeal Br. 10). Along the same line, Appellants
argue that Liu teaches away from the claimed combination because “Liu
teaches that PICs are ineffective in treating iron deficiency anemia and
provide no significant benefit (such as significantly lower side effects)”
(Appeal Br. 16).
These arguments are not persuasive. Although Liu discloses that the
ferrous salt composition was more effective than the PIC composition, Liu
also discloses that both compositions raised hemoglobin levels and that the
ferrous salt composition caused more GI side effects. A skilled worker
would therefore expect that a composition that combined a ferrous salt and a
PIC would provide a level of iron supplementation intermediate between
what is achieved by each product alone, while decreasing the nausea and
diarrhea more commonly caused by the ferrous salt. Since both the ferrous
salt and PIC raised hemoglobin levels, one of skill in the art would
reasonably expect that the combination product would be useful in treating
anemia.
Appellants also argue that the Specification provides evidence that the
claimed combination is unexpectedly effective, because “one of skill in the
art reading Liu would not expect that adding a PIC to a ferrous salt would
result in a composition more effective than the ferrous salt alone, or that
replacing a portion of the ferrous salt with a PIC would lead to an equally
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effective composition. The claimed invention, however, does just that.”
(Appeal Br. 13.) Appellants point to the data shown in the Specification’s
¶ 0024 as supporting their position (id. at 13-15).
This argument is also unpersuasive. Unexpected results must be
shown by comparison to the closest prior art, and must be supported by
factual evidence. See In re Baxter-Travenol Labs., 952 F.2d 388, 392 (Fed.
Cir. 1991) (“[W]hen unexpected results are used as evidence of
nonobviousness, the results must be shown to be unexpected compared with
the closest prior art.”); In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997)
(“[I]t is well settled that unexpected results must be established by factual
evidence. ‘Mere argument or conclusory statements in the specification
does not suffice.’”).
The Specification describes an experiment in which rats were
administered an iron supplement as either ferrous fumarate or a mixture of
ferrous fumarate and PIC (Spec. 8). The Specification states that blood
samples were collected and evaluated (id. at 9) but does not disclose the
results of the blood tests for the two groups of iron-supplemented rats.
The evidence provided by the Specification is inadequate to show that
the claimed composition would have been nonobvious. The Specification
does not compare the claimed composition to a composition containing only
PIC, so it does not allow a determination of whether the combination
product is improved at all, let alone unexpectedly, compared to PIC alone.
The Specification also does not disclose the evidence supporting its
conclusion that the claimed composition “provide[s] equivalent efficacy at
increasing serum iron levels, but . . . is significantly better tolerated” than
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ferrous fumarate alone (Spec. 10). For both reasons, the Specification does
not provide adequate evidence to conclude that the claimed composition is
unexpectedly superior to the prior art.
Finally, Appellants’ contention that there would have been no
reasonable expectation of success in combining a ferrous salt and a PIC
(App. Br. 13-14) is unpersuasive. Contrary to Appellants’ position,
obviousness does not require an expectation of more effective results. In
fact patterns like that presented here, obviousness only requires a reasonable
expectation that the combined components will form a composition that
continues to work for the intended purpose the separate components were
known to have. We agree with the Examiner (Ans. 4) that the test is met
here.
Claim 2 is directed to the composition of claim 1, with equal amounts
of iron derived from the ferrous iron salt and the PIC. The Examiner
concludes that it would have been obvious to one of ordinary skill in the art
to combine the ferrous salt and the PIC “using amounts that would have
given the same amount of iron derived from each source (it is noted that the
amounts of elemental iron taught for Ferrall, ferrous fumarate, and Niferex
… are 151 and 150 mg, respectively, nearly equivalent elemental iron
amounts” (Answer 4).
Appellants argue that the Examiner “failed to articulate any reasoning
explaining why it would be obvious to combine a ferrous iron salt and a PIC
in amounts that would give equal amounts of iron from each source”
(Appeal Br. 17).
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This argument is not persuasive. Liu discloses a comparison of a
ferrous salt composition and a PIC composition having almost equal
amounts of elemental iron, with the finding that both compositions raised
hemoglobin levels. Thus, it would have been obvious to one of skill in the
art mix the ferrous salt composition and PIC composition in amounts that
would maintain the 150-151 mg dosage of elemental iron taught by Liu.
Adjustment of the precise relative amounts, including a 50/50 mixture, of the
two components would involve only routine optimization. It is not inventive
to discover the optimum or workable values by routine experimentation.
See, e.g., In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997).
Appellants’ argument that the composition of claim 2 “provides
unexpected effectiveness and reduced side effects” (Appeal Br. 17), is
unpersuasive for the reasons discussed above with respect to claim 1.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that one
of skill in the art would have considered it obvious to combine a ferrous salt
and a PIC in view of Liu. Appellants have not provided evidence of
unexpected results that, when weighed with the evidence supporting the
Examiner’s rejection, shows that the claimed invention would not have been
obvious.
SUMMARY
We affirm the rejection of claims 1, 2, 4, 8, and 9 under 35 U.S.C.
§ 103(a).
Appeal 2010-003834
Application 11/243,043

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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

lp

JOHN S. PRATT, ESQ
KILPATRICK STOCKTON, LLP
1100 PEACHTREE STREET
SUITE 2800
ATLANTA GA 30309