Ex Parte Motyka et al

Board of Patent Appeals and Interferences

Apr 6, 2010

10828827 (B.P.A.I. Apr. 6, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MAX R. MOTYKA, RICK HARNISH,
STEPHEN D. ASHMEAD, and H. DEWAYNE ASHMEAD
__________

Appeal 2009-0083291
Application 10/828,827
Technology Center 1600
__________

Decided: April 7, 2010
__________

Before JAMES T. MOORE, Vice Chief Administrative Patent Judge,
RICHARD M. LEBOVITZ, and FRANCISCO C. PRATS, Administrative
Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to methods of
preparing and administering hypoallergenic metal amino acid chelate
compositions. The Examiner rejected the claims as anticipated and obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.

1 Albion International, Inc. is the Real Party in Interest (App. Br. 3).
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STATEMENT OF THE CASE
An amino acid chelate can be defined as “the product resulting from
the reaction of a metal ion from a soluble metal salt with amino acids having
a mole ratio of one mole of metal to one to three (preferably two) moles of
amino acids to form coordinate covalent bonds” (Spec. 2). Amino acid
chelates are advantageous from a nutritional standpoint because they are
“readily absorbed from the gut and into mucosal cells by means of active
transport” (id. at 4).
However, as “amino acids used to prepare amino acid chelates are
typically derived from protein hydrolysis, such amino acids can cause
allergic reactions in a small percentage of the population” (id. at 5).
Claims 38-54 are pending and on appeal (App. Br. 5). Claims 38 and
46, the independent claims, are representative and read as follows:

38. A method of preparing a hypoallergenic metal amino
acid chelate composition, comprising:
a) selecting an amino acid source determined to be
hypoallergenic;
b) selecting a metal source determined to be
hypoallergenic; and
c) chelating an amino acid of the amino acid source to a
metal of the metal source to form a hypoallergenic metal amino
acid chelate composition.

46. A method of administering a metal amino acid
chelate composition, comprising:
a) identifying a subject susceptible to a type of allergic
reaction;
b) formulating a metal amino acid chelate by:
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i) selecting an amino acid source determined to be
hypoallergenic with respect to the type of allergic
reaction;
ii) selecting a metal source determined to be
hypoallergenic with respect to the type of allergic
reaction, and
iii) chelating an amino acid of the amino acid
source to a metal of the metal source to form a
hypoallergenic metal amino acid chelate composition;
and
c) administering the hypoallergenic metal amino acid
composition to the subject.

The Examiner cites the following documents as evidence of
unpatentability:
Hsu US 5,504,055 Apr. 2, 1996
Ashmead US 6,426,424 B1 Jul. 30, 2002
Ashmead US 4,725,4272 Feb. 16, 1988

Yoshiharu Izumi et al., Production and Utilization of Amino Acids, 17
ANGEW. CHEM. INT. ED. ENGL. 176-183 (1978).

The Examiner has rejected the claims as follows:
(1) Claims 38-40, 44-46, 48, 49, and 52-54, under 35 U.S.C. § 102(b)
as anticipated by Hsu (Ans. 3-4);
(2) Claims 38-40, 44-46, 48, and 49, under 35 U.S.C. § 102(b) as
anticipated by Ashmead ‘424 (Ans. 4-5);
(3) Claims 38-40, 43-49, and 52-54, under 35 U.S.C. § 102(b) as
anticipated by Ashmead ‘427 (Ans. 5-6);

2 The Examiner provided an incorrect patent number for Ashmead ‘427 on
page 3 of the Answer.
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(4) Claims 41, 42, 50, and 51, under 35 U.S.C. § 103(a) as obvious
over Ashmead ‘427 and Izumi (Ans. 7-8).
ANTICIPATION
ISSUE
The Examiner finds that each of Hsu, Ashmead ‘424, and Ashmead
‘427 discloses a process that has all of the steps recited in independent
claims 38 and 46 (Ans. 3-6). Appellants contend, among other things, that
the Examiner has failed to provide an adequate evidentiary basis for finding
that the references inherently teach the claimed steps of selecting an amino
acid source determined to be hypoallergenic, and selecting a metal source
determined to be hypoallergenic (see, e.g., App. Br. 18-21).
The Examiner responds that the Specification defines the term
“hypoallergenic” as a composition that does not evoke an allergic reaction in
a particular class of subject, due to the absence in the composition of
specific allergens, such as soy, peanuts, tree nuts, crustaceans, fin fish, dairy,
wheat, and eggs, etc. (see Ans. 9). The Examiner reasons that, since none of
the references cited as anticipatory discloses such allergens in their
compositions, “the Examiner can only reasonably conclude that the prior art
compositions and methods of making and using the compositions are
hypoallergenic and read on the instant claims” (id. at 10).
Moreover, the Examiner argues, it is “contrary to good manufacturing
practice to make products with impurities that could be potentially lethal to
the consumers ingesting them without a distinct warning label as having
those impurities present and it is contrary to conventional wisdom to
administer products with those impurities to individuals with known
intolerance issues” (id. at 11). Therefore, the Examiner finds
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[O]ne of ordinary skill in the art would “determine” the types of
impurities in an ingredient, such as a metal or amino acid,
before formulating a composition, such as a metal amino-acid
chelate, and make an impurity free product and one of ordinary
skill in the art would “determine” a susceptible subject, for
example a child with a peanut allergy, and not administer a
product to that subject with the allergen in it. This is merely
common sense.

(Id.)
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to the anticipation rejections, therefore, is whether
Appellants have shown that the Examiner erred in finding that the cited
references disclose forming an amino acid metal chelate where the amino
acid is from a hypoallergenic source, and the metal is from a hypoallergenic
source, as recited in claims 38 and 46.

FINDINGS OF FACT (“FF”)
The Claimed Invention
1. Claim 38 recites a method of preparing a hypoallergenic metal amino
acid chelate composition. Both the amino acid and the metal must be from a
“source determined to be hypoallergenic.”
Claim 46 recites a method of administering a hypoallergenic
metal amino acid chelate composition to a subject identified as being
susceptible to a type of allergic reaction. Similar to claim 38, the
chelate composition must be prepared using an amino acid and metal
obtained from a “source determined to be hypoallergenic” with
respect to the subject’s allergy.
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2. The Specification states:
The term “hypoallergenic” refers to compositions where
care has been taken in formulation and/or production to ensure
minimal instance of allergic reactions in a target subject or class
of subjects. Hypoallergenic can also refer to a composition that
when contacted, e.g., topical, or ingested, e.g., food fortification
or nutritional supplement, at customary levels to provide a
nutritional, cosmetic, or medicinal effect, the contact or
ingestion does not produce an adverse discernable allergic
reaction to a target subject or class of subjects.

(Spec. 8.)
3. The Specification states:
The term “allergen” refers to a substance that causes
manifestations of allergy, such as a protein or antigen. The
FDA lists eight major allergen sources in the FDA Compliance
Policy Guide, CPG 555.250, which includes: soy, peanuts, tree
nuts (almonds, walnuts, etc.), crustaceans, fin fish, dairy, wheat,
and eggs. Other known allergens that affect a relatively large
percentage of the population may include corn, from which
maltodextrin is derived, gelatin, whey, chocolate, strawberries,
etc.

(Id. at 8-9)
4. Regarding allergenic metal sources, the Specification states:
For example, biological sources of metal may more likely
include allergens that certain target subjects may be allergic to.
Heme iron from hemoglobin, magnesium from chlorophyll,
calcium from lactose, magnesium from magnesium stearate
each exemplify metal sources that may be undesireable [sic] for
use in certain circumstances. However, if such metal sources
are processed such that allergens present are reduced to a level
that is acceptable, or the use of the metal source would not be
problematic with respect to a target subject class, then these
metal sources may be acceptable for use. In other words, on a
case by case basis, a metal source can be selected for use to
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meet the goals of the hypoallergenic composition to be formed.
Examples of metal sources that typically do not include
allergens include metal sulfates, metal carbonates, metal oxides,
metal hydroxides, elemental metals, and the like.

(Id. at 11.)
5. The Specification discloses that “[e]xamples of amino acid sources
that can be hypoallergenic include those not prepared by protein hydrolysis,
those wherein the amino acid source is prepared by protein hydrolysis using
a hypoallergenic protein, and amino acids that have been purified of
allergens, such as by chromatography or bind-release separation
technologies” (id.). Thus, “the naturally occurring amino acid used to make
the metal amino acid chelates may be provided by a production method
other than protein hydrolysis, e.g., synthetic preparation or fermentation”
(id. at 12).

The Prior Art
Hsu
6. Hsu discloses metal amino acid chelates “capable of delivering high
levels of desirable metal ions to plants, animals or human beings” (Hsu, col.
1, ll. 44-46).
7. Hsu discloses:
Highly critical to the invention is the deaeration of the
water used to produce the chelate. The presence of dissolved
oxygen appears detrimental to the end product as it can result in
a shifting of the valence state of the metal (e.g., Fe+2 to Fe+3).
It is also important that the calcium and magnesium
content of the water be reduced or eliminated. Suitable
procedures include distillation, deionization or softening the
water.
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(Id. at col. 3, ll. 14-22.)
8. Hsu discloses that its process can be applied to “a broad range of
metal ions including water soluble salts of iron, cobalt, copper, zinc,
manganese, magnesium, calcium, boron, molybdenum, and nickel or
mixtures thereof. A list of representative metal salts includes the water
soluble carbonates, sulfates, nitrates, oxides, hydroxides, chlorides,
phosphates and acetates or mixtures thereof” (id. at col. 2, ll. 47-53).
9. Hsu discloses that “[p]referred amino acids include glycine, lysine,
methionine, cysteine, glutamic acid and aspartic acid and mixtures thereof”
(id. at col. 2, l. 67, through col. 3, l. 2).
10. Hsu’s examples disclose the preparation of iron/citrate/glycine
chelates, calcium/malonic/lysine chelates, and other similar chelates, as well
as the administration of a number of those chelates to tomato, corn and bean
plants (id. at cols. 7-10).
11. Hsu does not disclose that the amino acids used in its processes should
be obtained from any particular source, nor does it disclose where the amino
acids used in its experiments were obtained.

Ashmead ‘424
12. Ashmead ‘424 discloses methods of preparing amino acid chelates
that “are more granular, dense, and free flowing than other amino acid
chelates prepared under similar reaction conditions” (Ashmead ‘424, col. 4,
ll. 33-35).
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13. Ashmead ‘424 states that chelates made by its methods can be used to
supply metal nutrients to plants, and also “used in food applications for
warm-blooded animals, including humans” (id. at col. 7, ll. 62-63).
14. Ashmead ‘424’s chelates are prepared by blending amino acids and
hydrated metal sulfates in particulate form with reaction modifiers, and then
heating the blend in an enclosed environment “for a time sufficient that the
waters of hydration from the hydrated metal sulfate salt are released and
provide the moisture necessary to effect a bonding reaction between the
electron rich functional groups of the amino acid ligand with the metal ion of
the sulfate salt” (id. at col. 4, ll. 28-32).
15. Ashmead discloses that the reaction modifiers in the compositions
“enhance the physical properties of the compositions and methods of the
present invention include any combination of starches, partially hydrolyzed
starches, powdered cellulose, and/or modified cellulose. These modifiers
may be provided from any know[n] source or in any known form” (id. at col.
5, l. 66, through col. 7, l. 4).
16. Regarding the amino acids useful in its methods, Ashmead ‘424
discloses:
Since the ligands of the present invention are generally
amino acids, the naturally occurring amino acids including
alanine, arginine, asparagine, aspartic acid, cysteine, cystine,
glutamine, glutamic acid, glycine, histidine, hydroxyproline,
isoleucine, leucine, lysine, methionine, ornithine,
phenylalanine, proline, serine, threonine, tryptophan, tyrosine,
valine, and combinations thereof are preferred. However,
ligands including dipeptides, tripeptides, and tetrapeptides
formed by any combination of the aforementioned amino acids
may be used.

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(Id. at col. 7, ll. 14-23.)
17. In its examples, Ashmead ‘424 discloses the preparation of chelates
using glycine, lysine, and methionine (id. at cols. 8-10).
18. Ashmead ‘424 does not, however, disclose that the amino acids used
in its processes should be obtained from any particular source, nor does it
disclose where the amino acids used in its experiments were obtained.

Ashmead ‘427
19. Ashmead ‘427 discloses “[f]lavored, effervescent, water soluble
compositions containing water-soluble and oil-soluble vitamins and amino
acid chelated minerals in bioavailable form” (Ashmead ‘427, abstract).
20. Ashmead ‘427 discloses that it is “well documented that minerals are
more bioavailable if administered in the form of chelates wherein the
chelating ligands are amino acids or protein hydrolysates” (id. at col. 1, ll.
58-61).
21. Ashmead ‘427 discloses:
The minerals capable of forming amino acid chelates for
which a U.S. RDA has been established are calcium, iron,
magnesium, zinc and copper. Manganese is also considered
essential although no U.S. RDA has been established. In
addition, other chelatable minerals such as cobalt, vanadium,
molybdenum, tin, nickel, selenium and chromium are also
considered to play essential roles in life’s processes. Any or all
of these metals, as amino acid chelates, may be utilized in the
present invention.

(Id. at col. 4, ll. 37-45.)
22. Ashmead ‘427 discloses:
Depending upon the ligand used the molecular weight of
any amino acid chelate may vary greatly. For example, the
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weight ratio of metal to ligand will be greatest if using pure
glycine, the simplist [sic] amino acid, as the ligand. However,
if using a polypeptide at the chelating ligand the ratio of metal
to ligand will be greatly diminished. Therefore, the amount of
amino acid chelate to be blended with the vitamin premix will
vary greatly depending upon the number of metals utilized and
the metal concentration.

(Id. at col. 5, l. 64 through col. 6, l. 5.)
23. In its examples, Ashmead ‘427 discloses the preparation of a
powdered mixes that contain “a mixture of iron, zinc, magnesium, calcium
and manganese amino acid chelates and potassium amino acid complex” (id.
at col. 9, ll. 45-47).
24. Ashmead ‘427 does not, however, disclose that the amino acids or the
metals used in its processes should be obtained from any particular source,
nor does it disclose where the amino acids or the metals used in its
experiments were obtained.

PRINCIPLES OF LAW
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . . After evidence or
argument is submitted by the applicant in response,
patentability is determined on the totality of the record, by a
preponderance of evidence with due consideration to
persuasiveness of argument.

“[W]hen the PTO shows sound basis for believing that the products of
the applicant and the prior art are the same, the applicant has the burden of
showing that they are not.” In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990);
see also In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
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However, the “very essence of inherency is that one of ordinary skill
in the art would recognize that a reference unavoidably teaches the property
in question.” Agilent Technologies, Inc. v. Affymetrix, Inc., 567 F.3d 1366,
1383 (Fed. Cir. 2009) (emphasis added); see also In re Oelrich, 666 F.2d
578, 581 (CCPA 1981) (“Inherency, however, may not be established by
probabilities or possibilities. The mere fact that a certain thing may result
from a given set of circumstances is not sufficient.”).
Thus, if “the disclosure is sufficient to show that the natural result
flowing from the operation as taught would result in the performance of the
questioned function, it seems to be well settled that the disclosure should be
regarded as sufficient.” Oelrich, 666 F. 2d at 581 (quoting Hansgirg v.
Kemmer, 102 F.2d 212, 214 (CCPA 1939)).

ANALYSIS
A preponderance of the evidence supports Appellants’ contentions
that the Examiner erred in finding that Hsu, Ashmead ‘424, and Ashmead
‘427 meet the limitations in the claims requiring the amino acid and metal in
the claimed methods to be obtained from hypoallergenic sources.
While Hsu is fairly particular about the oxygen, calcium, and
magnesium content in the water used to prepare its chelates (FF 7), Hsu’s
generic disclosure does not place any specific requirements on the source of
its amino acids (see FF 9), or identify any suitable amino acid sources, much
less a source known or determined to be hypoallergenic as recited in the
claims. Hsu does not identify the source of the amino acids used in its
examples (FF 10, 11).
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We agree with the Examiner that Hsu does not disclose that of any of
the allergens identified by Appellants’ Specification (FF 3) are present in its
compositions. We do not agree, however, that the absence of such a
disclosure is a sufficiently sound basis for finding that Hsu’s compositions
necessarily lack such allergens.
Rather, given Hsu’s lack of any positive disclosure that its amino
acids should be highly purified or prepared in a particular way, the
preponderance of the evidence shows that the natural result of following
Hsu’s teachings is that Hsu’ compositions do not necessarily, that is, do not
inherently, contain an amino acid derived from a hypoallergenic source, as
that term is defined in the instant application.
We therefore reverse the Examiner’s rejection of claims 38 and 46,
and their dependent claims, as anticipated by Hsu.
As the Examiner points out, Ashmead ‘424 similarly fails to disclose
that any of its compositions contain the allergens listed in Appellants’
Specification. On the other hand, however, Ashmead ‘424 does not disclose
the source of the amino acids used in its examples (see FF 17, 18).
To the contrary, Ashmead ‘424’s generic disclosure does not restrict the
amino acids to any specific sources. It might be true, as the Examiner
argues, that a manufacturer producing Ashmead ‘424’s chelates with
allergenic starting materials would label them so as to warn the relevant
segments of the population of the allergic danger.
However, the Examiner did not provide evidence that such practices,
or similar manufacturing standards, demonstrate that producing Ashmead
‘424’s chelates according to that reference’s disclosure necessarily entails
the use of a hypoallergenic amino acid source, as required by claims 38 and
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46, particularly given Ashmead ‘424’s lack of any specific source
requirements for its amino acids. We therefore also reverse the Examiner’s
rejection of claims 38 and 46, and their dependent claims, as being
anticipated by Ashmead ‘424.
Ashmead ‘427, on the other hand, contemplates using “pure glycine”
in its chelates (FF 22). As Appellants’ Specification concedes, purified
amino acids can be considered hypoallergenic (FF 5).
We acknowledge, as the Examiner argues, that Ashmead ‘427 does
not disclose that its metals were derived from allergenic sources like the
ones identified Appellants’ Specification (see FF 4). Nonetheless, Ashmead
‘427 does not disclose any specific source for the metals used in its chelates
(see FF 21, 23). Thus, at best, it is possible that Ashmead ‘427’s metals
were obtained from a hypoallergenic source. As noted above, however,
inherency cannot be based on probabilities or possibilities.
As the Examiner has not advanced an adequate basis for finding that
the metal nutrients used in Ashmead ‘427’s were derived from a
hypoallergenic source, we reverse the Examiner’s rejection of claims 38 and
46, and their dependent claims, as anticipated by Ashmead ‘427.
OBVIOUSNESS
ISSUE
The Examiner rejected claims 41, 42, 50, and 51, under 35 U.S.C.
§ 103(a) as obvious over Ashmead ‘427 and Izumi (Ans. 7-8). Those claims
read as follows:
41. A method as in claim 38, wherein the amino acid
source is not prepared by protein hydrolysis.

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42. A method as in claim 38, wherein the amino acid
source is prepared by protein hydrolysis, and wherein the
protein used in the hydrolysis is hypoallergenic.

50. A method as in claim 46, wherein the amino acid
source is prepared by a method other than protein hydrolysis.

51. A method as in claim 46, wherein the amino acid
source is prepared by protein hydrolysis, and wherein the
protein used in the hydrolysis is hypoallergenic.

The Examiner concedes that Ashmead ‘427’s methods do not prepare
amino acids by the methods recited in these claims, and cites Izumi to
demonstrate the obviousness of those methods (Ans. 7).
Appellants contend that the Examiner has “failed to show that each
and every element of the claimed invention is contained in the combined
references” (App. Br. 30). Specifically, Appellants argue, Izumi “never
discloses or teaches protein hydrolysis where the protein is hypoallergenic”
(id. at 31). Additionally, Appellants urge, “even though Izumi discloses
various techniques for producing amino acids, Izumi does not teach or
disclose each and every element of claims 38 and 46, from which claims
41-42 and 50-51 respectively depend” (id.).
In particular, Appellants argue:
For claim 38, neither Ashmead ‘427 nor Izumi teach
selecting an amino acid determined to be hypoallergenic or
selecting a metal source determined to be hypoallergenic.
For claim 46, neither Ashmead ‘427 nor Izumi teach
identifying a subject susceptible to a type of allergic reaction;
formulating a metal amino acid chelate by selecting an amino
acid determined to be hypoallergenic and selecting a metal
source determined to be hypoallergenic; or administering the
hypoallergenic metal amino acid chelate composition to a
subject.
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(Id. at 31-32.)
The Examiner disagrees “for the same common sense reasons
described in detail above” (Ans. 12). For convenience, we again reproduce
the Examiner’s summation of his position:
[O]ne of ordinary skill in the art would “determine” the types of
impurities in an ingredient, such as a metal or amino acid,
before formulating a composition, such as a metal amino-acid
chelate, and make an impurity free product and one of ordinary
skill in the art would “determine” a susceptible subject, for
example a child with a peanut allergy, and not administer a
product to that subject with the allergen in it. This is merely
common sense.

(Id. at 11.)
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether Appellants have overcome
the evidence of record establishing that Ashmead ‘427 and Izumi would
have taught or suggested methods having all of the features recited in claims
41, 42, 50, and 51, to an artisan of ordinary skill.
FINDINGS OF FACT
25. Appellants contend, and the Examiner does not dispute, that the
company “Similac offers various forms of its baby formula including a
regular formula, Similac Advance Infant Formula, and a hypoallergenic
formula, Similac Alimentum Hypoallergenic Formula” (App. Br. 25-26
(citing http://welcomeaddition.com)).
26. Izumi discloses that amino acids can be prepared “by extraction from
protein hydrolyzates, by fermentation with the aid of microorganisms, by
enzymatic processes, and by chemical synthesis” (Izumi 176).
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PRINCIPLES OF LAW
In KSR Int’ l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), the
Supreme Court emphasized “an expansive and flexible approach” to the
obviousness question. The Court nonetheless reaffirmed that “a patent
composed of several elements is not proved obvious merely by
demonstrating that each of its elements was, independently, known in the
prior art.” Id. at 418.
Rather, as the Court stated:
[I]t can be important to identify a reason that would have
prompted a person of ordinary skill in the relevant field to
combine the elements in the way the claimed new invention
does . . . because inventions in most, if not all, instances rely
upon building blocks long since uncovered, and claimed
discoveries almost of necessity will be combinations of what, in
some sense, is already known.

Id. at 418-419 (emphasis added); see also id. at 418 (requiring a
determination of “whether there was an apparent reason to combine the
known elements in the fashion claimed by the patent at issue”) (emphasis
added).
The Court advised, however, that in determining whether the prior art
supplied a reason for practicing the claimed subject matter, the analysis
“need not seek out precise teachings directed to the specific subject matter of
the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” Id. at
418; see also id. at 421 (“A person of ordinary skill is . . . a person of
ordinary creativity, not an automaton.”).
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ANALYSIS
Appellants’ arguments do not overcome the evidence of record that
Ashmead ‘427 and Izumi would have suggested methods having all of the
features recited in claims 41, 42, 50, and 51, to an artisan of ordinary skill.
It may be true, as Appellants argue, that neither Ashmead ‘427 nor Izumi
explicitly states that metal amino acid chelates should be prepared using
amino acids and metals from sources determined to be hypoallergenic.
As noted above, however, the obviousness analysis is not limited to
the references’ explicit disclosures. KSR, 550 U.S. at 418. Rather, the
analysis must take account of what an ordinary artisan would have inferred
from those teachings. Id.
Thus, in the instant case, an artisan of ordinary skill preparing a
hypoallergenic nutritional product like Similac’s baby formula (FF 25)
would have been advised by Ashmead ‘427 of the superior bioavailability of
metallic mineral nutrients in chelate form (FF 20, 21). We agree with the
Examiner that the ordinary artisan, being a person of common sense, and
being prompted by Ashmead ‘427 to include chelated minerals in such
hypoallergenic nutritional formulations, would have been further prompted
to prepare the chelates using amino acids and metals from sources
determined to be hypoallergenic, as recited in claim 38, so as to avoid a
harmful reaction when administering the chelates to allergic individuals, as
recited in claim 46.
For similar reasons, we also agree with the Examiner that an ordinary
artisan, advised by Izumi that amino acids were obtainable from sources
other than protein hydrolysis, such as fermentation or enzymatic or chemical
syntheses (FF 26), would have considered it obvious to use those known
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amino acid sources in preparing metal amino acid chelates for use in a
hypoallergenic product, as recited in claims 41 and 50. With respect to
claims 42 and 51, we further agree with the Examiner that, given the concern
for an allergic reaction, an ordinary artisan preparing amino acids via protein
hydrolysis as disclosed by Izumi (FF 26), for use in hypoallergenic
nutritional products, would have been prompted to ensure that the protein
starting material was itself hypoallergenic.
Thus, Appellants’ arguments do not overcome the evidence of record
supporting the conclusion that an ordinary artisan would have considered it
obvious to prepare metal amino acid chelates using metals and amino acids
obtained from hypoallergenic sources, including known
non-protein-hydrolysate sources, or from hydrolysates obtained from
hypoallergenic proteins. We therefore affirm the Examiner’s rejection of
claims 41, 42, 50, and 51 as being obvious in view of Ashmead ‘427 and
Izumi.
SUMMARY
We reverse the Examiner’s rejection of claims 38-40, 44-46, 48, 49,
and 52-54, under 35 U.S.C. § 102(b) as anticipated by Hsu.
We also reverse the Examiner’s rejection of claims 38-40, 44-46, 48,
and 49, under 35 U.S.C. § 102(b) as anticipated by Ashmead ‘424.
We also reverse the Examiner’s rejection of claims 38-40, 43-49, and
52-54, under 35 U.S.C. § 102(b) as anticipated by Ashmead ‘427.
However, we affirm the Examiner’s rejection of claims 41, 42, 50,
and 51, under 35 U.S.C. § 103(a) as being obvious over Ashmead ‘427 and
Izumi.

Appeal 2009-008329
Application 10/828,827

20
TIME PERIOD
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-IN-PART

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