Ex Parte Secretin

Patent Trial and Appeal Board

Jul 5, 2016

13167491 (P.T.A.B. Jul. 5, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/167,491 06/23/2011
29157 7590
K&L Gates LLP-Chicago
P.O. Box 1135
CHICAGO, IL 60690
07/07/2016
FIRST NAMED INVENTOR
Marie-Cristine Secretin
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.
3712036-01281 8174
EXAMINER
SMITH, PRESTON
ART UNIT PAPER NUMBER
1792
NOTIFICATION DATE DELIVERY MODE
07/07/2016 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 MARIE-CRISTINE SECRETIN
Appeal2014-006546
Application 13/167 ,491
Technology Center 1700
Before BRADLEY R. GARRIS, PETER F. KRATZ, and
ROMULO H. DELMENDO, Administrative Patent Judges.
DELMENDO, Administrative Patent Judge.
DECISION ON APPEAL
The Applicant (hereinafter the "Appellant") 1 appeals under 35 U.S.C.
§ 134(a) from a decision of the Primary Examiner to reject claims 1-16.2
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 The Appellant states that the real party in interest is "Nestec S.A." (Appeal
Brief filed January 30, 2014, hereinafter "Appeal Br.," 2).
2 Appeal Br. 12-26; Non-Final Office Action entered September 9, 2013,
hereinafter "Non-Final Act.," 1).
Appeal 2014-006546
Application 13/167,491
BACKGROlH~D
The current application is a continuation of Application 10/564,805
('805 Application) filed May 17, 2006, now abandoned (see Bibliographic
Data Sheet). In the parent '805 Application, the Examiner's rejections of
claims directed to subject matter similar to those presented for review in the
current appeal were affirmed. See Ex parte Secretin, https://e-
foia.uspto.gov/Foia/RetrievePdf?system=BPAI&flNm=fd2012003153-06-
11-2013-1. 3
The subject matter on appeal relates to an "infant or follow-on
formula," which is described as a nutritional composition intended for
infants and/or young children (Specification, hereinafter "Spec.," i-f 2, Abst.).
According to the Appellant, feeding the formula to an infant promotes
immune defenses, as demonstrated by an enhanced response to vaccinations
and/or improved gut barrier function and lower levels of intolerance to cow
milk protein, coupled with satisfactory physical development (Appeal Br. 6-
7).
Representative claim 1 is reproduced from the Claims Appendix (page
i) attached to the Appeal Brief as follows:
1. An infant or follow-on formula comprising a source of
proteins, a source of lipids, a source of carbohydrates, and
probiotics comprising Bifidobacterium longum BB 536 and
Lactobacillus paracasei rhamnosus GG (ATCC 53103) in a
3 Contrary to the requirement set forth in 3 7 C.F .R. § 41.3 7 ( c )( 1 )(ii), the
Appeal Brief failed to include a "Related Appeals" section notifying the
Board of the prior decision on appeal in the parent '805 Application.
Although the Appellant refers to the prior decision in the Reply Brief filed
May 13, 2014 at page 2, it was only after the Examiner referred to it in the
Examiner's Answer (Ans. 10).
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Appeal 2014-006546
Application 13/167,491
' ' 1 ' ,.. ... n.h ' ... nO ,.. I rLLl ,.. .... ,.. 1 1 • • ... total amount or iu~ to iw crwg'~J or tne rormma, wnerem me
source of lipids includes arachidonic acid (ARA) in an amount
of 0.2 to 1.2% of the formula and docosahexaenoic acid (DHA)
in an amount ofO.l to 1.4% of the formula, the ratio of
ARA:DHA between 0.8:1and1.2:1, and the DHA content is
between 0.2 and 0.5% of total fatty acids in the lipid source.
THE REJECTIONS
On pages 3-8 of the Examiner's Answer entered March 14, 2013
(hereinafter "Ans."), the Examiner withdrew a lack of written description
rejection under 35 U.S.C. § 112, i-f 1, and an obviousness-type double
patenting rejection of claim 1 but maintained two rejections under 35 U.S.C.
§ 103(a), which are listed as follows:
I. Claims 1-3 and 9-11 as unpatentable over Carlson et al.
(hereinafter "Carlson")5 in view of Halpin-Dohnalek et al.
(hereinafter "Halpin-Dohnalek"), 6 Van Hoey-De-Boer et al.
(hereinafter "Van Hoey-De-Boer"), 7 Ogata et al. (hereinafter
"Ogata"), 8 as evidenced by Caplan et al. (hereinafter "Caplan")9
[
4J Neither the claim nor the Specification explains what "cfu" denotes, but it
appears that the Appellant intended "CPU," which stands for "colony
forming unit" (Evidence Appendix, Ex. D at 1366, n. 1).
5 US 6,306,908 Bl issued October 23, 2001.
6 US 5,902,578 issued May 11, 1999.
7 EP 0 904 784 Al published March 31, 1999.
8 T. Ogata et al., "Effect of Bifidobacterium longum BB536 Yogurt
Administration on the Intestinal Environment of Healthy Adults," 11
Microbial Ecology in Health and Disease 41 (1999).
9 M. Caplan et al., "Bifidobacterial Supplementation Reduces the Incidence
ofNecrotizing Enterocolitis in a Neonatal Rat Model," 117
Gastroenterology 577-583 (1999) (abstract only).
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Appeal 2014-006546
Application 13/167,491
1 TT 1 , 1 /"1 • I', ll'.T T 1 °'°''° 1 {\ 1 ana ttorrocKs et al. ~neremaner --11orrocKs-J; iv ana
II. Claims 4-8 and 12-16 as unpatentable over the combined
teachings of the aforementioned references and two additional
references-namely, Kratky et al. (hereinafter "Kratky") 11 and
Boehm et al. (hereinafter "Boehm"). 12
DISCUSSION
The Appellant provides various arguments under separate headings
identified by various claim groupings. We address claims separately only to
the extent that the Appellant's arguments in support of separate patentability
comply with 37 C.F.R. § 41.37(c)(l)(iv). Otherwise, all claims stand or fall
together with representative claim 1.
A. Claims 1 & 2
Because the Appellant does not argue claim 2 separately from claim 1,
we confine our discussion to the latter claim (Appeal Br. 9-16). See 37
C.F.R. § 41.37(c)(l)(iv).
The Examiner found that although Carlson discloses an infant formula
including, inter alia, 0.41 weight% ARA and 0.14 weight% DHA of total
fatty acids (corresponding to 7 mg of DHA per day based on administration
of 100 kcal/kg/day for a 1 kg infant), it does not describe the DHA content
to be "between 0.2 and 5% of total fatty acids in the lipid source," as recited
10 L.A. Horrocks et al., "Health Benefits of Docosahexaenoic Acid (DHA),"
40 Pharmacol. Res. 211-225 (1999) (abstract only).
11 US 6,777,391 Bl issued August 17, 2004.
12 G. Boehm et al., "Effect of Increasing Dietary Threonine Intakes on
Amino Acid Metabolism of the Central Nervous System and Peripheral
Tissues in Growing Rats," 44 Pediatr. Res. 900-906 (1998) (abstract only).
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Appeal 2014-006546
Application 13/167,491
in claim l (Ans. 2-3, 8-9). Nevertheless, based on Carlson's teaching that
the amount of DHA may fall within a range disclosed as 0.25-35 mg per kg
per day and Horrocks's teaching that DHA boosts brain health, the Examiner
concluded that a person having ordinary skill in the art would have found it
obvious to arrive at the Appellant's DHA content range as specified in claim
1 by routine experimentation (id. at 3, 8-9).
Regarding the amounts of ARA and DHA based on total formula
weight, the Examiner found that the ranges specified in claim 1 are known in
the art to be the ranges of amounts for these acids in breast milk (id. at 3--4)
(citing Spec. i-f 18). The Examiner found further that, because Carlson seeks
to produce a formula having amounts of ARA and DHA similar to breast
milk, a person having ordinary skill in the art would have formulated the
composition to have ARA and DHA in amounts as recited in the claim (id. at
4).
Regarding the probiotics and their total amount recited in claim 1, the
Examiner found that, in view of the other references, a person having
ordinary skill in the art would have been prompted to add them into
Carlson's formula in appropriate amounts for their known beneficial effects
(id. at 4--5).
The Appellant contends that contrary to the Examiner's position,
Carlson does not teach that the composition can contain 0.25-35 mg of DHA
(Appeal Br. 10). The Appellant further contends that Horrocks "merely
teaches that the visual activity of healthy, full-term formula-fed infants 'is
increased when their formula includes DHA"' but "[ n Jo where does
Horrocks teach or suggest that the effects of DHA can be increased by
increasing its dosage relative to the amount disclosed by Carlson or suggest
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Appeal 2014-006546
Application 13/167,491
that the amount disclosed by Carlson 1s msufficient and would require an
increase" (id.). According to the Appellant, "there is no evidence that
routine experimentation would result in the claimed amount of DHA" (id. at
11 ). Specifically, the Appellant argues that "there is no evidence that
optimizing the amount of DHA for its brain health enhancing properties, the
benefit recognized by [Horrocks], would result in the claimed amounts that
provide healthy mental development and strengthen natural immune
defenses ... . "(id.). Additionally, the Appellant urges that evidence of
unexpected results has been provided to rebut any prima facie case of
obviousness (id. at 13-16).
The Appellant's arguments, considered in light of the relied-upon
evidence, fail to reveal a reversible error in the Examiner's rejection of claim
1. In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011).
We start with the limitation "the DHA content is between 0.2 and
0.5% of total fatty acids" (claim 1). The Examiner specifically relied on
Carlson's Table IV disclosure, which is found at column 12, line 51---column
13, line 42 (Ans. 3). There, Carlson describes a specific fatty acid profile in
which the DHA content in the total fat blend was 0.14 weight percent, which
is described as corresponding to "about 7 mg of DHA [per kg of infant
weight] per day" (col. 13, 11. 1--40). Although the fatty acid composition
described in Table IV included only 0.14 weight percent of DHA based on
total fatty acids, Carlson teaches that the DHA amount may be in the range
of "about 0.25 to about 35 mg per kg [of infant weight] per day" (col. 3, 1.
46---col. 4, 1. 2). Because an amount of about 7 mg of DHA per kg of infant
weight] per day corresponds to 0 .14 weight percent of the total fatty acid
blend-a value that is very close to the Appellant's specified lower endpoint
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Application 13/167,491
of 0.2 weight percent, it would reasonably appear that certain daily dosages
ofDHA above 7 mg but below about 35 mg per kg of infant weight, as
disclosed in Carlson, would encompass a range of weight percentage values
that are close to, fall within, or overlap the Appellant's specified range of
"between 0.2 and 0.5 % of total fatty acids in the lipid source," as recited in
claim 1. The Appellant does not direct us to any contrary evidence to show
otherwise. In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) ("A prima
facie case of obviousness typically exists when the ranges of a claimed
composition overlap the ranges disclosed in the prior art."); id. ("We have
also held that a prima facie case of obviousness exists when the claimed
range and the prior art range do not overlap but are close enough such that
one skilled in the art would have expected them to have the same
properties."); id. ("[T]he existence of overlapping or encompassing ranges
shifts the burden to the applicant to show that his invention would not have
been obvious .... ").
Moreover, the Examiner found further that it was known that DHA
provides a beneficial effect on brain health (Ans. 3) (citing Horrocks Abst.,
which states that DHA "is essential for the growth and functional
development of the brain in infants"). Determining a workable or even
optimum range within the confines of Carlson to achieve DHA' s known
beneficial effect on brain health-a benefit of interest in the current
application (Spec. i-f 9}-would have been within the level of a person
having ordinary skill in the art. Peterson at 1330 ("The normal desire of
scientists or artisans to improve upon what is already generally known
provides the motivation to determine where in a disclosed set of percentage
ranges is the optimum combination of percentages."); In re Aller, 220 F.2d
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Application 13/167,491
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.").
As for "the ratio of ARA:DHA between 0.8: 1 and 1.2: 1" limitation
(claim 1), we adopt the Examiner's reasoning (Ans. 3--4) as our own. As
found by the Examiner, Carlson teaches that the "formula will achieve blood
serum levels of A[R]A and DHA more closely resembling those of breast
fed infants" (col. 16, 11. 17-20). Although Carlson teaches a "more
preferred" range of ARA:DHA ratios ("about 2: 1 to about 4: 1 ")that is
outside the range recited in claim 1 (Carlson, col. 3, 11. 59-63), the current
Specification acknowledges that, globally on the mean, human milk contains
0.1-1.4% DHA and 0.2-1.2% ARA (Spec. i-f 18). Given Carlson's goal to
produce a formula that approximates human breast milk, a person of
ordinary skill in the art would have been prompted to formulate a
composition including DHA and ARA in relative amounts and weight ratios
encompassed by claim 1.
That the Appellant may have discovered an additional benefit
(enhanced natural immune defenses) resulting from the use of the claimed
formula relative to Carlson does not preclude an obviousness conclusion.
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 420 (2007) ("Under the correct
analysis, any 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
the elements in the manner claimed."); Ex parte Obiaya, 227 USPQ 58, 60
(BP AI 1985) (holding that the recognition of a result flowing naturally from
following the suggestion of the prior art cannot be the basis for patentability
when the differences would otherwise be obvious).
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Application 13/167,491
In any event, the Examiner specifically found that it is known in the
art, as evidenced by various references such as Caplan (Abst.), Ogata (p. 41),
and Van-Hoey-De-Boer (i1i13--4, 17-20), that the probiotics recited in claim
1 were known to provide enhanced immune response (Ans. 4--5). We find
no error in the Examiner's findings. Therefore, we discern no persuasive
merit in the Appellant's argument based on the notion that the claimed
formula strengthens natural immune defenses.
Next, we consider the Appellant's arguments that the invention recited
in claim 1 provides unexpected results. Specifically, the Appellant contends
that "[ n Jew and unexpected results relative to the prior art are provided by
the [S]pecification and also Exhibits C and D submitted on October 31,
2012" (Appeal Br. 14). 13 According to the Appellant, Examples 1 and 2 of
the Specification demonstrate "unexpected results for the claimed formula
relative to a formula that lacks probiotics, such as the formula disclosed by
Carlson" (id.). Regarding Exhibits C and D (Chouraqui), the Appellant
urges that "Chouraqui highlights the advantage of the specific combination
of Bifidobacterium longum BB536 and a strain of Lactobacillus rhamnosus
together with DHA and ARA in the claimed proportion" (id.). According to
the Appellant, "[t]he effect of the claimed combination is an improved long-
13 Exhibit C (Evid. App.) purports to be a "Declaration by Philippe
Steenhout to be filed with respect to the opposition to EP 1 63 8 414" (Ex. C
at 1 ). At the time the document was prepared, the Declarant was a medical
director of the Infant Nutrition Clinical Development department at Nestec,
Ltd. in Switzerland. Exhibit D (Evid. App.) is: Jean Pierre Chouraqui et al.,
"Assessment of the Safety, Tolerance, and Protective Effect Against
Diarrhea of Infant Formulas Containing Mixtures of Probiotics or
Probiotics and Prebiotics in a Randomized Controlled Trial," 87 Am. J. Clin.
Nutr. 1365-1372 (2008) (hereinafter "Chouraqui").
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Application 13/167,491
term natural immune response in an infant or a baby, especially one that
results in a reduced risk of diarrhea in infants" (id.).
The burden of showing unexpected results rests on the applicant who
asserts them. In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972).
Consistent with the Examiner's position (Ans. 9--10; Non-Final Act.
12; February 1, 2013 Office Action at 2), we find that the Appellant's
proffered showing falls short of satisfying that burden.
As for Examples 1 and 2, we find no reason to depart from the
analysis as set forth in the prior Board decision in the '805 Application, Ex
parte Secretin at 4--12, and, therefore, we adopt it as our own. Ogata, for
example, teaches that "BB536 has been reported to reduce cancer risk, ...
enhance immunity ... and increase bone density in animal experiments"
(Ogata 41 ). Another reference, Van-Hoey-De-Boer, teaches the addition of
Bifidobacterium (e.g., B. longum ), Enterococcus faecium, and a
Lactobacillus strain (e.g., Lactobacillus rhamnosus) to an infant formula to
prevent and treat disorders of the gastrointestinal tract (Abst.; i-f 17-19).
Therefore, a person having ordinary skill in the art would have been
prompted to add these probiotics into Carlson's composition for their known
beneficial effects. In re Skol!, 523 F.2d 1392, 1397 (CCPA 1975)
("Expected beneficial results are evidence of obviousness of a claimed
invention, just as unexpected beneficial results are evidence of
unobviousness."); Asyst Techs., Inc. v. Emtrak, Inc., 544F.3d1310, 1316
(Fed. Cir. 2008) ("[E]vidence of secondary considerations does not always
overcome a strong prima facie showing of obviousness.").
The Appellant contends that the Examiner's assessment of the
Steenhout Declaration (Ex. C) and the Chouraqui paper (Ex. D) was
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Application 13/167,491
erroneous (Appeal Br. 15). In addition, the Appellant argues that "reducing
the risk of necrotizing enterocolitis as taught by Carlson would not lead the
skilled artisan to expect strengthened immune defenses, let alone the
experimental results of improved long-term natural immune response in an
infant or a baby shown in Exhibit D" (id. at 16).
But Chouraqui itself states that "[b ]ecause other possible confounding
factors during the observational period (such as diet) were not studied here,
it is not possible to attribute [the] observation solely to the effect of
probiotics" and that the "results have to be confirmed" (Chouraqui at 1372).
The Appellant does not direct us to any additional evidence confirming
Chouraqui' s hypothesis. As we explained above, expected beneficial
results, as taught by the prior art references, are evidence of obviousness just
as unexpected beneficial results are evidence of nonobviousness. Therefore,
notwithstanding the Appellant's proffered evidence of secondary
considerations, we find no reversible error in the Examiner's assessment of
all the evidence as a whole and the overall obviousness conclusion as to
claim 1 based thereon.
For these reasons, we uphold the rejection of claim 1.
B. Claims 3-16
The Appellant's arguments in support of claims 3-16 are similar to
those presented for claim 1 (Appeal Br. 17-26). Therefore, we find them
unpersuasive for the same or similar reasons given for claim 1.
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Application 13/167,491
SUMMARY
The Examiner's decision to reject claims 1-16 is affirmed.
No time period for taking any subsequent action in connection with
this appeal maybe extended under 37 C.F.R. § 1.136(a)(l).
AFFIRMED
12