Ex Parte Haschke et al

Patent Trial and Appeal Board

Aug 30, 2016

12298078 (P.T.A.B. Aug. 30, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/298,078 10/22/2008
29157 7590
K&L Gates LLP-Chicago
P.O. Box 1135
CHICAGO, IL 60690
09/01/2016
FIRST NAMED INVENTOR
Ferdinand Haschke
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.
3712036-00899 4358
EXAMINER
BEKKER, KELLY JO
ART UNIT PAPER NUMBER
1791
NOTIFICATION DATE DELIVERY MODE
09/01/2016 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):
USpatentmail@klgates.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte FERDINAND HASCHKE and CORINNE RENEE MAGLIOLA
Appeal2015-004061
Application 12/298,078
Technology Center 1700
Before CHUNG K. PAK, JEFFREY T. SMITH, and
WESLEY B. DERRICK, Administrative Patent Judges.
PAK, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 appeal under 35 U.S.C. § 134(a) from the Examiner's
decision finally rejecting claims 1through6, 13, 14, 18, 20, and 21. 2 We
have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 Appellants identify the Real Party in Interest as Nestec, S.A. (Appeal Brief
filed December 2, 2014 ("App. Br.") at 2.)
2 Appellants cancelled claim 19 in an Amendment filed December 2, 2014,
the same date they filed their Appeal Brief.
Appeal2015-004061
Application 12/298,078
The subject matter on appeal is generally directed to a nutnt10nal
composition comprising a source of hypoallergenic hydrolyzed whey
protein, a fat source comprising 11 to 20% by weight of a structured lipid in
which 40 to 55% of palmitic acid residues contained in the structured lipid
are esterified at the Sn2 position, and a carbohydrate source. (Spec. 2, 11.
22-27; 5, 1. 31---6, 1. 2.)
Details of the appealed subject matter are recited in representative
claim 1, which is reproduced below from the Claims Appendix to the Appeal
Brief:
1. A nutritional composition comprising:
from 26 to 3 8 g/l of a source of hypoallergenic
hydrolysed whey protein with a degree of hydrolysis between 8
and 20,
from 37 to 46 g/l of a fat source of which 20 to 40% by
weight is medium chain triglycerides and which has an n6:n3
ratio between 6 and 12, wherein the fat source comprises from
11 to 20% by weight of a structured lipid in which 40 to 55% of
palmitic acid residues contained in the structured lipid are
esterified at the Sn2 position,
from 50 to 100 g/l of a carbohydrate source, and
from 3.2 to 4.0 grams of protein per 100 kcal.
The Examiner maintains the following grounds of rejection in the
Answer entered on January 15, 2015 ("Ans."):
Claims 1-6, 13, 14, 18, 20, and 21under35 U.S.C. § 103(a) as
unpatentable over the disclosure of U.S. Patent 6,777,391 Bl issued in the
name of Kratky et al. on August 1 7, 2004 (hereinafter referred to as
"Kratky") in view of U.S. Patent 6,863,918 B2 issued in the name ofBindels
et al. on March 8, 2005 (hereinafter referred to as "Bindels"), Pahud, J., et
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Application 12/298,078
al., Allergenicity of Whey Protein: Its J\lf odification by Tryptic In Vitro
Hydrolysis of the Protein, 4 J. Pediatric Gastroenterology and Nutrition 408
(1985) (hereinafter referred to as "Pahud"), and as evidenced by U.S. Patent
Application Publication 2002/0004527 Al, published in the name of Auestad
et al. on January 10, 2002 (hereinafter referred to as "Auestad"); and
Claim 21 under 35 U.S.C. § 103(a) as unpatentable over the disclosure
of Kratky in view of Bindels and Pahud as evidenced by Auestad, and in
further view of U.S. Patent 4,216,236, issued August 5, 1980 in the name of
Mueller et al. (hereinafter referred to as "Mueller").
DISCUSSION
Upon consideration of the evidence on this appeal record and each of
Appellants' contentions, we determine that Appellants have not identified
reversible error in the Examiner's rejections of claims 1---6, 13, 14, 18, 20,
and 21under35 U.S.C. § 103(a). Accordingly, we affirm these rejections
for the reasons set forth in the Final Action entered September 16, 2014
("Final Act.") and the Answer. We add the discussion below primarily for
emphasis and completeness.
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Application 12/298,078
Rejection of claims 1---6, 13, 14, 18, 20, and 21under35 U.S.C. § 103(a) as
unpatentable over Kratky, Bindels, and Pahud, evidenced by Auestad 3
Appellants do not dispute the Examiner's finding that Kratky
discloses an infant formula having all of the ingredients of the nutritional
composition recited in claim 1, except for (1) the recited degree of
hydrolysis of a whey protein included in the formula, (2) the recited amounts
of the whey protein, a lipid source, and a carbohydrate source included in the
formula expressed in units of g/l, and (3) the recited lipid source comprises
11-20% of a structured lipid in which 45-55% of the palmitic acid residues
contained in the structured lipid are esterified at the Sn2 position. (Compare
Ans. 2-5 with App. Br. 7-12.)
With respect to the recited degree of hydrolysis of a whey protein
included in the formula, the Examiner acknowledges that Kratky does not
specify the degree of hydrolysis of its hypoallergenic hydrolyzed whey
protein. Ans. 3. To address this feature missing from Kratky, the Examiner
relies on Pahud's disclosure to show that whey protein hydrolysates having a
degree of hydrolysis of 12.9 or 16.1 do not elicit allergic reactions, which
3 We limit our discussion to those claims separately argued, and claims not
separately argued stand or fall with the argued claims. 3 7 C.F .R.
§ 41.37(c)(l)(iv). Appellants argue claims 1---6, 14, and 18 as a group on the
basis of claim 1, and separately argue claims 13, 20, and 21 as a group on
the basis of claim 13. (See generally App. Br. 7-12.) However, Appellants
present the same arguments for claims 1 and 13. (Id.) Therefore, for the
purposes of this appeal, we select claim 1 as representative, and decide the
propriety of the rejection of claims 1---6, 13, 14, 18, 20, and 21 based on
claim 1 alone.
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Application 12/298,078
Appellants do not dispute. (Compare Ans. 3 with App. Br. 7-12.) The
Examiner concludes that it would have been obvious to one of ordinary skill
in the art at the time of the invention to utilize a hydrolyzed whey protein
having a degree of hydrolysis of 12.9 or 16.1 as the hypoallergenic
hydrolyzed whey protein in Kratky' s infant formula because Pahud teaches
that such whey proteins do not elicit allergic reactions. (Ans. 3.)
With respect to the recited amounts of the whey protein, a lipid
source, and a carbohydrate source included in the formula expressed in units
of g/l, the Examiner acknowledges that although Kratky discloses an infant
formula (nutritional composition) that comprises hydrolyzed whey protein, a
lipid source, and a carbohydrate source, Kratky expresses the amounts of
these components present in the formula in units of g/100 kcal, rather than in
units of g/l as recited in claim 1. (Id.) To address this discrepancy in units,
the Examiner calculates the amounts of the components in Kratky's
composition in units of g/l based on Auestad's disclosure of the caloric
density of infant formulas. (Ans. 3--4.) Appellants do not dispute the
Examiner's finding that the amounts of hydrolyzed whey protein, lipid
source, and carbohydrate source in Kratky' s formula calculated in units of
g/l based on Auestad's disclosures overlap the ranges for the corresponding
components recited in claim 1. (Compare Ans. 3--4 with App. Br. 7-12.)
With respect to the recited lipid source comprises 11-20% of a
structured lipid in which 45-55% of the palmitic acid residues contained in
the structured lipid are esterified at the Sn2 position, the Examiner
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Application 12/298,078
acknowledges that Kratky does not disclose that the lipid source in the infant
formula comprises 11-20% of a structured lipid in which 45-55% of the
palmitic acid residues contained in the structured lipid are esterified at the
Sn2 position, and relies on Bindels to address this feature missing from
Kratky's disclosures. (Ans. 4--5.) Appellants do not dispute the Examiner's
finding that Bindels discloses an infant formula that includes a lipid (fatty
acid triglyceride) component in which at least 40% of the palmitic acid
residues present in the lipid component are in the 2- or ~-position (Sn2
position) of the triglycerides. (Compare Ans. 4 with App. Br. 7-12.)
Appellants also do not dispute the Examiner's finding that Bindel discloses
that such a lipid having palmitic acid residues largely present in the 2-
position, which Bindels refers to as a "structured fat," is commercially
available under the name Betapol. (Compare Ans. 4 with App. Br. 7-12.)
Nor do Appellants dispute the Examiner's finding that Bindels discloses that
structured fats are easily digested by infants, and are better absorbed by
infants than lipids lacking palmitic acid residues largely present at the 2-
position. (Compare Ans. 4 with App. Br. 7-12.)
Based on these undisputed findings, the Examiner concludes that it
would have been obvious to one of ordinary skill in the art at the time of the
invention to utilize a structured fat in which at least 40% of the palmitic acid
residues are esterified at the 2-position as part of the lipid component (fat
source) in Kratky' s infant formula for easy digestion and better absorption of
the fat as taught by Bindels. (Ans. 4.) The Examiner further concludes that
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it would have been obvious to optnn1ze the amount of structured fat included
in the lipid component of Kratky' s infant formula through routine
experimentation because Bindels discloses that the level of palmitic acid
residues at the 2-position of the triglycerides (structured fats) in the lipid
component affects the digestibility and absorption of the lipid component,
thus establishing that the amount of structured fat is a result-effective
variable. (Ans. 4--5.)
Appellants argue---citing to Bindels' Examples 1-3-that Bindels
discloses that the lipid source in the infant formula contains only 6.9-7.6%
structured lipid, and contend that the Examiner fails to identify a reason why
one of ordinary skill in the art would have increased this amount to 11-20%
as recited in claim 1. (App. Br. 7-8.)
However, Bindels' disclosures are not limited to the examples cited
by Appellants, and the entirety of Bindels' disclosures must be evaluated for
what they would have fairly suggested to one of ordinary skill in the art at
the time of the invention. Merck & Co. v. Biocraft Labs., Inc., 874 F.2d at
807 (quoting In re Lamberti, 545 F.2d 747, 750 (CCPA 1976) ("[T]he fact
that a specific [embodiment] is taught to be preferred is not controlling,
since all disclosures of the prior art, including unpreferred embodiments,
must be considered."); In re Fracalossi, 681 F.2d 792, 794 n.1(CCPA1982)
(A prior art reference's disclosure is not limited to its examples.); In re Boe,
355 F.2d 961, 965 (CCPA 1966) (All of the disclosures in a prior art
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Application 12/298,078
reference "must be evaluated for what they fairly teach one of ordinary skill
in the art.").
Here, Bindels broadly discloses that palmitic acid residues should
make up more than 10%, preferably 16---24%, of all of the fatty acid residues
present in the triglycerides used in the lipid component of the infant formula.
(Bindels col. 14, 11. 9--12.) Bindels further discloses, as the Examiner
correctly finds, that preferably at least 40% of these palmitic acid residues
should be in the 2- or ~-position of the triglycerides (Sn2 position). 4
(Bindels col. 14, 11. 25-31.) Bindels further discloses that such triglycerides
include "structured fats" in which the triglycerides have been subjected to
re-esterification so that the "palmitic acid residues are for a large part
present in the 2-position." (Bindels col. 14, 11. 32--41.) In other words,
Bindels teaches that the amounts of the structured fats or lipids (preferred
lipid) in the lipid component essentially corresponds to the amount of
palmitic acid residues present in the 2-position in the lipid component.
Thus, Bindels impliedly discloses employing structured fats (structured
lipids) in amounts that overlap with the range of the structured lipids recited
in claim 1 ( 11 to 20%) to provide at least 40% of palmitic acid residues in
the 2- or ~-position (Sn2 position) of the triglycerides, which is inclusive of
4 Bindels also discloses that no more than 10. 7% of the palmitic acid
residues should be in the Snl or Sn3 position of the triglycerides in the lipid
component. (Bindels col. 14, 11. 13-20.) Thus, Bindels indicates that 40%
to 89.3% of the palmitic acid residues in triglycerides in the lipid component
should be in the 2-position.
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Application 12/298,078
40 to 55% of the pahnitic acid residues in the 2- or ~-position recited in
claim 1.
Moreover, as the Examiner correctly finds, Bindels recognizes that the
digestability and absorbability of the lipid component of the infant formula
is affected by the amount of palmitic acid residues in the 2-position of the
triglycerides (structure fats or lipids) in the lipid component, thus
establishing that the amount of the structured fat used is a result-effective
variable. Ans. 4--5; Bindel, col. 14, 11. 1-5 and 46-52; In re Applied
Materials, Inc., 692 F.3d 1289, 1297 (Fed. Cir. 2012) ("A recognition in the
prior art that a property [or a result] is affected by the variable is sufficient to
find the variable result-effective."). Accordingly, we find no error in the
Examiner's determination one of ordinary skill in the art would have been
led to include an optimum amount of structured lipid, such as that claimed,
to provide at least 40% of palmitic acid residues in the 2- or ~-position (Sn2
position) of the triglycerides in Kratky's infant formula through nothing
more than routine experimentation. In re Boesch, 617 F.2d 272, 276 (CCPA
1980) ("[D]iscovery of an optimum value of a result effective variable in a
known process is ordinarily within the skill of the art."); In re Aller, 220
F.2d 454, 456 (CCPA 1955) ("[W]here the general conditions of a claim are
disclosed in the prior art, it is not inventive to discover the optimum or
workable ranges by routine experimentation.").
Appellants appear to argue that the Examiner fails to establish that the
amount of structured lipid in the fat component of Bindels' infant formula is
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Application 12/298,078
a result-effective variable, asserting in the Reply Brief that the Examiner
"has not established that a functional relationship between the amount of
structured lipid and the rate of growth for very low birth weight premature
infants was known in the art." (Rep. Br. 3-5.) However, as discussed
above, the Examiner correctly finds that Bindels recognizes that the level of
structured lipid in the lipid component of the infant formula affects the
digestability and absorbability of the lipid component, thus establishing-
contrary to Appellants' arguments-that the level of structured lipid is a
result-effective variable. Appellants' arguments are therefore unpersuasive
of reversible error.
Appellants also refer to Bindels' disclosure that including a structured
lipid in the lipid component of infant formula allows the amount of the lipid
component in the formula to be reduced, and Appellants argue that this
disclosure teaches away from increasing the amount of the lipid component,
which includes the structured lipid, in the infant formula. (App. Br. 8.)
Referring again to the composition of Bindels' experimental examples,
Appellants contend that Bindels thus teaches away from increasing the
amount of structured lipid in the lipid formula to an amount above 6.9-7 .6%.
(Id.)
However, the teaching in Bindels referred to by Appellants must be
considered in the context of the entirety of Bindels' disclosures, and must
not be taken to apply only to the compositions of Bindels' experimental
examples. As discussed above, Bindels also broadly discloses that palmitic
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acid residues should make up more than 10% of all fatty acid residues
present in the triglycerides in the lipid component, and indicates that more
than 40% the palmitic acid residues in the lipid component should be in the
2-position of the triglycerides (structured fats or lipids). Accordingly, even
if the amount of the lipid component were reduced as argued by Appellants
based on Bindels' disclosure that including a structured fat in the lipid
component allows the total amount of the lipid component included in
formula to be reduced, Bindels still would have suggested a percentage of
structured lipid in the lipid component that overlaps with the range of the
structured lipid recited in claim 1. Bindels thus does not teach away from
infant formula that includes a fat source comprising a structured lipid in an
amount overlapping the range recited in claim 1, and Appellants' arguments
are therefore unpersuasive of reversible error. In re Fulton, 391 F.3d 1195,
1201 (Fed. Cir. 2004) ("[t]he prior art's mere disclosure of more than one
alternative does not constitute a teaching away from any of these alternatives
because such disclosure does not criticize, discredit, or otherwise discourage
the solution claimed"); In re Gurley, 27 F.3d 551, 552-53 (Fed. Cir. 1994).
Appellants further argue that the function of the structured lipid in
Bindels' infant formula differs from the function of the structured lipid in
Appellants' nutritional composition. (App. Br. 9.) Specifically, Appellants
contend that the structured lipid in Bindels' formula functions to decrease
the amount of lipid included in the formula, while the structured lipid in
Appellants' formula functions to achieve a growth rate for pre-term infants
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similar to that which they would have achieved in utero. (Id.) However,
this argument lacks persuasive merit because it is based on limitations that
do not appear in the claims. In re Self, 671F.2d1344, 1348 (CCPA 1982)
("[A ]ppellant's arguments fail from the outset because ... they are not based
on limitations appearing in the claims."); KSR Int 'l Co. v. Teleflex Inc., 550
U.S. 398, 419 (2007) ("[i]n determining whether the subject matter of a
patent claim is obvious, neither the particular motivation nor the avowed
purpose of the patentee controls.")
Moreover, Appellants' Specification explains that "that fatty acid
residues are better absorbed from the Sn2 position and that this is
particularly important for the absorption of palmitic acid by pre-term
infants." (Spec. 5, 11. 29--31.) Appellants' Specification goes on to explain
that it is therefore "preferable to include in the fat source from 5 to 20% of a
structured lipid in which the triglycerides have been subjected to enzymatic
or other re-esterification such that the palmitic acid residues are mostly
present in the Sn2 position." (Spec. 5, 11. 31-34.) As discussed above,
Bindels discloses that that because fat mixtures containing structured fats are
better absorbed from the infant gut than fat mixtures that do not contain
structured fats, use of such fat mixtures in infant formula allows the total
amount of the lipid component in the formula to be reduced. 5 Therefore,
5 Bindels also teaches its lipid content "improves the biological availability
of divalent cations such as calcium and/or the fats/fatty acids present in the
formula[,]" thus implying that its fat content affects a growth rate of infants.
(Bindels col. 14, 11. 1-5.)
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Application 12/298,078
like Appellants, Bindels achieves increased fat absorption by the infant gut
by including structured fat in the lipid component of the infant formula.
Appellants' argument are therefore unpersuasive of reversible error.
Accordingly, we sustain the rejection of claims 1-6, 13, 14, 18, 20,
and 21under35 U.S.C. § 103(a).
Rejection of claim 21under35 U.S.C. § 103(a) as unpatentable over Kratky,
Bindels, Pahud, and Mueller, evidenced by Auestad
Appellants rely on the same arguments advanced in connection with
the Examiner's rejection of claim 13, from which claim 21 depends, based
on Kratky, Bindels, and Pahud, evidenced by Auestad, and further assert that
Mueller fails to remedy the deficiencies of these references. (App. Br. 12-
13.) Because we are unpersuaded of reversible error in the Examiner's
rejection based on Kratky, Bindels, and Pahud, evidenced by Auestad as
discussed supra, Appellants' position as to this ground of rejection is equally
without merit. Accordingly, we sustain the rejection of claim 21 under 35
U.S.C. § 103(a) as unpatentable over Kratky, Bindels, Pahud, and Mueller,
evidenced by Auestad.
CONCLUSION
In view of the reasons set forth above, we affirm the Examiner's
rejections of claims 1through6, 13, 14, 18, 20, and21under§103(a).
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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)(l )(iv).
AFFIRMED
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