Ex Parte Krebs et al

Patent Trial and Appeal Board

Oct 27, 2016

12941571 (P.T.A.B. Oct. 27, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/941,571 11/08/2010
23370 7590 10/31/2016
KILPATRICK TOWNSEND & STOCKTON LLP
Mailstop: IP Docketing - 22
1100 PEACHTREE STREET
SUITE 2800
ATLANTA, GA 30309
Peter J. Krebs
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.
39073/398129 1006
EXAMINER
THOMAS, TIMOTHY P
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
10/31/2016 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):
ipefiling@kilpatricktownsend.com
j lhice@kilpatrick.foundationip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PETER J. KREBS, ALLISON KREBS-BENSCH, and
JEROME W. MINCY1
Appeal2014-0000482
Application 12/941,571
Technology Center 1600
Before ULRIKE W. JENKS, ROBERT A. POLLOCK, and
TA WEN CHANG, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) 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 According to Appellants, the real party in interest is U.S. Pharmaceuticals
Corporation. (App. Br. 3.)
2 An oral hearing was held on Oct. 4, 2016.
Appeal2014-000048
Application 12/941,571
STATEMENT OF THE CASE
Claims 1 and 4 are on appeal 3, and can be found in the Claims
Appendix of the Appeal Brief. Claim 1 is representative of the claims on
appeal, and reads as follows:
1. An orally administrable iron supplement composition for
treatment or prophylaxis of iron deficiency, comprising:
an effective amount of ferrous fumarate; and
an effective amount of polysaccharide iron complex,
wherein the polysaccharide iron complex comprises from about
38 wt% to about 46 wt% iron, and
wherein the amount of iron derived from the ferrous fumarate is
the same as the amount of iron derived from the polysaccharide
iron complex.
(App. Br. 37, Claims Appendix.)
Appellants request review of the Examiner's rejection of claims 1 and
4 under 35 U.S.C. § 103(a) as unpatentable over Hermelin4 in view of Liu,5
Coe,6 and Montgomery.7
The issues with respect to this rejection are: (i) Does the evidence of
record support the Examiner's conclusion that the prior art renders the
claims prima facie obvious? (ii) If so, have Appellants presented evidence of
3 Claims 5-7, 10, and 13-15 are withdrawn from consideration. (App.
Br. 5).
4 Hermelin et al., US 2003/0190355 Al, published Oct. 9, 2003
("Hermelin").
5 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. J. Hematology 416-420 (2004) ("Liu").
6 Coe et al., Comparison of Polysaccharide Iron Complexes Used as Iron
Supplements, 57 J. Inorg. Biochem. 287-292 (1995) ("Coe").
7 Montgomery et al., US 3,821,192, issued June 28, 1974 ("Montgomery")
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secondary considerations, that when weighed with the evidence of
obviousness, is sufficient to support a conclusion of non-obviousness?
Findings of Fact
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art as set out in the Final Action8 and Answer.
For emphasis only we highlight the following:
FF 1. Hermelin teaches that "administration of a high dose of poorly
absorbed iron complexes may cause siderosis of the gut wall and a
variety of side effects such as nausea" in addition to other ailments
(Hermelin i-f 8).
FF2. Hermelin teaches compositions containing "at least two iron-
providing materials in a single dosage form wherein at least one of the
iron-providing materials contains a modified release mechanism,
matrix, or coating" (Hermelin, Abstract). The "combination provides
both an initial absorption of iron and a prolonged absorption of iron
over time upon administration to a patient" (id. at i-f 9).
FF3. Hermelin teaches using soluble iron salt selected from a group that
includes "ferrous fumerate" (id. at i-f 40).
FF4. Hermelin teaches using iron complexes including among others
a polysaccharide iron complex (PIC) (id. at i-f 43).
FF5. Hermelin exemplifies two compositions containing two different iron
sources in each formulation (see id. at i-fi-1 83-87, and claims 1, 2, 11 ).
Specifically, examples 1 and 3 of Hermelin include ferrous fumarate
and micromask carbonyl iron (see id. at i-fi-1 83 and 87).
8 Office Action mailed Jan. 10, 2013 ("Final Act.").
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FF6. Liu teaches treating patients with ferrous fumarate iron supplement or
a ferric iron polysaccharide complex (Liu, Abstract). Specifically, Liu
"compared a combination ferrous iron product (Ferall) with a ferric
polysaccharide complex product (Niferex) as oral treatment of iron
deficiency anemia in our patient population" (id. at 417). "Both iron
supplements ... raised mean hemoglobin level over the course of the
12-week study .... Both iron supplements were well tolerated, no
patients withdrawing from the study for a GI reason or for any other
type of self-reported adverse event" (id. at 419).
FF7. Montgomery teaches the production of iron complexes having
"between 40 and 46 percent iron" (Montgomery col. 1, 11. 44--45).
Montgomery compared the absorption of ferrous sulfate and iron-
dextrin, and concludes that "iron from the iron-dextrin compound is at
least as absorbable as iron from ferrous sulfate" (id. at col. 4, 11. 10-
12).
Principle of Law
"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).
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 .... [T]he idea of combining
them flows logically from their having been individually taught
in the prior art.
In re Kerkhoven, 626 F .2d 846, 850 (CCP A 1980)( citations omitted).
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Analysis
The Examiner acknowledges that Hermelin alone "would require
picking and choosing to arrive at the combination of PIC iron complex and
applicant[s] elected ferrous fumarate" (Final Act. 5; Ans. 4; FF1-FF5). The
Examiner finds that "Hermelin features ferrous fumarate in two of three
Example formulations, motivating selection of this iron source; combination
of this component with PIC, from the species recited in claim 11 would have
been obvious; i.e., selection of two iron species for a two-iron component
single dose combination" (Ans. 6). In other words, Hermelin's exemplified
formulations would lead the ordinary artisan to select ferrous fumarate as the
soluble iron salt narrowing the source of the other iron-providing material
for the composition (see Hermelin i-f 39; FF3 & FF5). The Examiner
acknowledges that PIC is but one of the iron complexes named in a list (see
Ans. 4). However, picking and choosing among various options is entirely
proper the context of an obviousness rejection. See In re Arkley, 455 F.2d
586, 587-588 (CCP A 1972). Additionally, the Examiner does not stop with
the Hermelin reference alone and looks to the additional teachings of Liu,
Coe, and Montgomery in formulating the obviousness rejection.
The Examiner finds that Liu teaches the administration of both
claimed iron forms, however, only as individual components (see Final Act.
5---6; Ans. 6; FF6). Similarly, Montgomery teaches administration of an
"iron-polysaccharide complex and uses it alternately with a ferric
compound, to treat iron deficiency; both increase hemoglobin and red cell
volume" (Ans. 6; FF7). The Examiner relies on the Kerkhoven rationale for
providing the motivation "to combine the two components into a single
composition for the same purpose of treating iron deficiency anemia,
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Application 12/941,571
providing a combination iron source, rendering the combination prima facie
obvious, in addition to the specific teaching of Hermelin for the combination
of two different iron sources." (Ans. 7; see Final Act. 9-10, emphasis
omitted).
Appellants contend (A) that the art does not recognize, teach, or
suggest "the different mechanisms by which ferrous fumarate and PIC are
absorbed" (Reply Br. 3); (B) that there is no direction in "Hermelin on
which of the many iron complexes should be selected and combined with
ferrous fumarate or any other iron salts" (App. Br. 17); (C) that "Hermelin
specifically teaches that various iron-providing materials disclosed in the
document are not equivalent" (Reply Br. 10-11); (D) that there is "no
motivation to pick and choose" PIC and ferrous fumarate from the extensive
lists in Hermelin (Reply Br. 1 O); and (E) that "Liu fails to provide any
suggestion or motivation to combine ferrous and ferric iron sources in a
single dose form" (App. Br. 18).
(A) Appellants contend that the art does not recognize the different
absorption mechanisms (see Reply Br. 3). We do not find this argument
persuasive as the claims are silent with respect to requiring different routes
of absorption. It is well established that limitations not appearing in the
claims cannot be relied upon for patentability. In re Self, 671 F .2d 1344,
1348(CCPA1982).
(B) Appellants contend that Hermelin does not provide guidance
for picking the claimed iron components (see App. Br. 17). "[N]either the
particular motivation nor the avowed purpose of the patentee controls ....
[A ]ny need or problem known in the field of endeavor at the time of
invention and addressed by the patent can provide a reason for combining
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the elements in the manner claimed." KSR Int'! Co. v. Teleflex Inc., 550
U.S. 398, 418, 419-420 (2007). Hermelin teaches formulations containing
two different iron components (FF2 & FF5). A reference may be relied
upon for all that it would have reasonably suggested to one having ordinary
skill the art, including non-preferred embodiments. See Merck & Co. v.
Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (The disclosure in
the prior art of "a multitude of effective combinations does not render any
particular formulation less obvious. This is especially true because the
claimed composition is used for the identical purpose taught by the prior
art").
The Examiner reasons that Hermelin's exemplified formulations
direct one of ordinary skill in the art to using ferrous fumarate as one of the
iron-containing sources, leaving only the second iron-component open for
selection from various lists. Hermelin explicitly names PIC as one of the
suitable iron complexes contemplated in the formulation (see Ans. 4). In
addition, Hermelin teaches that PIC can be used either in a modified or non-
modified form in the formulation (compare Hermelin claims 11 and 12).
The Examiner however, does not rely on Hermelin alone in making the
rejection (see Ans. 11-12), but combines Hermelin with the teachings of
Liu, Coe, and Montgomery. Liu specifically teaches the use of ferrous
fumarate and a polysaccharide-iron complex for treating anemia in patients
(FF6). Thus, Hermelin in combination with Liu directs the ordinary artisan
to select these two iron containing components for treating anemia.
Accordingly, the combination of references provides guidance for picking
the individual components.
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(C) Appellants contend "that various iron-providing materials" are
not equivalent (see Reply Br. 10-11). We are not persuaded that having
different mechanisms of absorption disqualifies these compositions as art
recognized equivalents as iron supplements (see Reply Br. 10-11 ). Even if
Hermelin recognizes that different iron sources have different properties -
each of the iron sources is considered an equivalent because each supplies
iron for the purpose of treating anemia (FF1-FF5; see also Ans. 12 ("both
ferrous fumarate and PIC are taught as suitable iron forms by Hermelin ....
The teachings of Liu and Montgomery establish both iron forms are used to
supply iron in therapy of iron deficiency anemia").
(D) We are also not persuaded by Appellants' arguments that there
is no motivation to pick and choose ferrous fumarate and PIC, especially
since each must be selected from a list disclosed in Hermelin (see Reply Br.
10; App. Br. 17)). Here, the Examiner finds that Hermelin exemplifies two
ferrous fumarate compositions, thereby directing the ordinary artisan to
choose this water soluble salt as one of the iron-providing materials leaving
only the selection of the second iron-providing material open to be chosen
from a list. Just because one has to select the second iron-providing
component from a list, even if from an extensive list, does not make any one
combination contemplated in Hermelin less obvious. See Merck & Co. v.
Biocraft Labs., Inc., 874 F.2d 804, 807. Because each of the iron-providing
materials in Hermelin is used for the same purpose, i.e., supplying iron to a
patient, the selection of any of them in combination with ferrous fumarate
would be obvious (FF1-FF5).
(E) We are also not persuaded by Appellants contention that Liu
fails to combine ferrous and PIC in a single dose form (see App. Br. 18).
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The test for obviousness is what the combined teachings of the references as
a whole would have suggested to those of ordinary skill in the art. In re
Keller, 642 F.2d 413, 425 (CCPA 1981). Thus, Appellants' focus on a
single reference when the rejection is based on a combination is not
persuasive. Additionally, combining two composition when each is taught
in the art to be useful for the same purpose is obvious based on the rationale
provided in Kerkhoven. Here, Liu discloses that ferrous fumerate and PIC
individually are useful for increasing hemoglobin levels in an anemic patient
population (FF6). We find no error with the Examiner's rationale that
combining ferrous fumerate and PIC in a single formulation is obvious based
on the combined teachings of Hermelin, Liu, Coe, and Montgomery.
After considering the evidence and the arguments, we conclude the
weight of the evidence favors the Examiner's conclusion of obviousness. In
addition to the arguments addressed above, we adopt the Examiner's
reasoning (see Final Act. 3-11), and agree that the Examiner properly found
Appellants' arguments unpersuasive (see Ans. 3-23; Final Act. 11-23).
Because the Examiner presents a prima facie case of obviousness, we
consider whether Appellants submit sufficient evidence or argument in
rebuttal. "After a prima facie case of obviousness has been made and
rebuttal evidence submitted, all the evidence must be considered anew." In
re Eli Lilly & Co., 902 F.2d 943, 945 (Fed. Cir. 1990) (citing In re Piasecki,
745 F.2d 1468, 1472 (Fed. Cir. 1984)).
In an effort to rebut the Examiner's conclusion of obviousness
Appellants provide declaration evidence to address the following: (1) that
"physicians clearly prefer USPC's dual iron products over previously
available products" (Reply Br. 12); (2) that "the two iron materials identified
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and claimed by Appellant satisfied a long felt need" (Reply Br. 11; App. Br.
29-30); (3) that "showing superior effect on iron blood parameters in
comparison with both the single-source compositions containing ferrous
fumarate or PIC" (App. Br. 34); and ( 4) commercial success based on "the
sales data presented demonstrate an increase in the relative number of dual
iron products sold, compared to single iron products" (Reply Br. 16; App.
Br. 31-33).
(1) Appellants present four declarations, the Bensch9, Rao 10,
Kopp 11 , and Cortese12 Declarations in an effort to establish nonobviousness
based on secondary considerations. "The Examiner does not dispute that 95
pages of physicians' letters have been provided as part of a declaration, and
the physicians clearly prefer one or more of the dual iron products from
USPC" (Ans. 13; see Bensch Deel., exhibits). The dispute lies with the
conclusions that should be drawn from these letters. The Examiner notes
that many of the letters presented do not state which USPC products are
compared, thus, it is not possible to establish that the only difference
between the single iron and dual iron product is the actual iron component
(Ans. 13-14). The Examiner also points out that, because additional
excipients are found in the various USPC formulations and any of these
excipients could contribute to providing improved tolerability, it is essential
9 Declaration under 37 C.F.R. § 1.132 by Allison Krebs Bensch signed
Oct. 9, 2012 ("Bensch Deel.").
10 Declaration under 37 C.F.R. § 1.132 by Dr. Arnn R. Rao signed Oct. 19,
2012 ("Rao Deel.").
11 Declaration under 37 C.F.R. § 1.132 by Dr. James Henry Kopp signed
Oct. 3, 2012 ("Kopp Deel.").
12 Declaration under 37 C.F.R. § 1.132 by Dr. Jack L. Cortese signed Oct. 3,
2012 ("Cortese Deel.").
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Application 12/941,571
that the only differences between formulation is the iron component (Ans.
13-14; see also Ans. 15 ("the skilled artisan would not be able to establish
from comparative testimonials that the excipients do not affect iron uptake
or tolerability, and thus contribute to the physicians' preferences")). The
Examiner explains that components such as gelatin can "sooth[] the
stomach/intestines in these formulations, reducing GI side effects further, or
promoting better absorption" (Ans. 16). We agree with the Examiner's
finding that, although an impressive number of physicians now recommend
or prescribe the dual iron containing supplements to their patients, the
evidence is not sufficient to establish that the recommendation is because of
the claimed iron component. In order to establish non-obviousness there has
to be a nexuses between claimed iron formulation, and the reason for
prescribing the product that cannot be influenced by other factors, such
advertising or promotional incentives. Accordingly, we agree with the
Examiner that that the presentation of physicians letters and declarations in
the Bensch Deel. stating preferences for the dual iron formulations is not
sufficient to establish non-obviousness when weighed against the totality of
the prior art evidence.
(2) Appellants contend that the declarations establish long-felt need
(Reply Br. 11; App. Br. 29-30). We are not persuaded. As explained by the
Examiner (Ans. 16-17), to establish a long-felt need, three elements must be
proven: First, the need must have been a persistent one that was recognized
by ordinarily skilled artisans. In re Gershon, 372 F.2d 535, 538 (CCPA
1967). Second, the long-felt need must not have been satisfied by another
before Appellants' invention. See Newell Companies, Inc. v. Kenney Mfg.
Co., 864 F.2d 757, 768 (Fed. Cir. 1988) ("[o]nce another supplied the key
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element, there was no long-felt need or, indeed, a problem to be solved
.... "). Third, the invention must, in fact, satisfy the long-felt need. In re
Cavanagh, 436 F.2d 491, 496 (CCPA 1971).
As explained above ( 1), the physicians letters and the declarations are
not sufficient to establish the first element of the long-felt need analysis
because iron supplements that increase blood iron levels were known and
available, even if the claimed formulations provide reduced side effects.
Additionally, the Kopp. Deel. implies that not every patient suffers from side
effects and for that patient population the single iron formulations are
suitable iron sources (see Kopp. Deel. i-f 10 ("In some cases where a patient
taking a single source iron produce has had problems, I prescribe dual
iron").)
The Examiner explains that Appellants are also not able to meet the
second element of the long-felt need analysis. Although Hermelin does not
exemplify an iron composition containing ferrous fumarate and PIC,
"Hermelin clearly teaches two-iron component compositions that improve
iron absorption, and reduce the GI side effects of single iron therapies"
(Ans. 17; FF1-FF5). We agree with the Examiner's rational as set out in the
Answer, and agree that the evidence does not support a finding of long-felt
need.
( 3) We are also not persuaded by Appellants contention that there
is an unexpected effect based on the dual iron composition, containing
ferrous fumarate or PIC (see App. Br. 34). There has to be a nexus between
the unexpected property and the claimed invention. See In re Kao, 639 F.3d
1057, 1068 (Fed. Cir. 2011) ("Where the offered secondary consideration
actually results from something other than what is both claimed and novel in
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the claim, there is no nexus to the merits of the claimed invention."). The
Examiner raises three points with regard to the unexpected property
argument.
First, the Examiner explains that all the commercial compositions
described in the Bensch Declaration contain additional excipients in addition
to the dual iron sources. The Examiner notes that many of the tested dual
iron products contain gelatin and questions "whether gelatin as a component
sooths the stomach/intestines in these formulations, reducing GI side effects
further, or promoting better absorption" and resulting in less side effects
(Ans. 18).
Second, the Examiner explains that the reduced side effects using a
dual iron containing components can indeed be expected. "[T]he teachings
of record, especially the teachings of Hermelin, lead to the expectation of
reduction in side effects, and increase in iron absorption levels with dual iron
products" (Ans. 22).
Hermelin makes clear that the combination of two iron
substances enhancing the rate and extent of absorption of iron
(paragraph 0009); i.e., replenishing iron stores would be the
result of enhanced rate and extent of absorption; And the side
effects of single iron products, resulting from high dosing of
poorly absorbed iron discussed at paragraph 0008 would have
been minimized.
(Ans. 19). In other words, using two iron-containing components allows for
the reduction of each induvial component in order to achieve the same iron
dosing. Thus, by simply cutting in half the component known to causes side
effects, the ordinary artisan would expect a reduction in the side effects.
Finally, the Examiner also points out that any of the comparisons
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made in the declarations do not compare the claimed product to the closest
prior art product of Hermelin (Ans. 22).
( 4) We are also not persuaded by Appellants contention that they
have shown commercial success (Reply Br. 16; App. Br. 31-33). We agree
with the Examiner "that sales data presented demonstrate an increase in the
relative number of dual iron products sold, compared to single iron products.
But the evidence ... does not include a market share, compared to any
competitor products" (Ans. 17). The results in the change in sales between
the two products marketed by the same company can be for other reasons
such as increased marketing efforts of one product over the other, the use
incentives and other promotional or marketing efforts can drive the sales of
one product versus the other (see Ans. 17-18). Commercial success "is
relevant in the obviousness context only if there is proof that the sales were a
direct result of the unique characteristics of the claimed invention - as
opposed to other economic and commercial factors unrelated to the quality
of the patented subject matter." In re Huang, 100 F.3d 135, 140 (Fed. Cir.
1996). "In other words, a nexus is required between the sales and the merits
of the claimed invention." Id. Without knowing the market share of the
product over time it cannot be evaluated with respect to the competitors'
products and it cannot be evaluated whether the sales of the dual iron
product are due to the claimed compositional components by taking over the
competitors market share.
Accordingly, we agree with the Examiner that Appellants'
presentation of the four declarations and the physicians letters stating
preferences for the dual iron formulations are not sufficient to establish non-
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obviousness when weighed against the totality of the prior art evidence. The
preponderance of the evidence weighs against Appellants.
SUMMARY
We affirm the rejection of claims 1 and 4 under 35 U.S.C. § 103(a)
over Hermelin, Liu, Coe, and Montgomery.
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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