Ex Parte Lönnerdal et al

Patent Trial and Appeal Board

Nov 29, 2018

14391494 (P.T.A.B. Nov. 29, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/391,494 10/09/2014
55694 7590 12/03/2018
DRINKER BIDDLE & REATH (DC)
1500 K STREET, N.W.
SUITE 1100
WASHINGTON, DC 20005-1209
FIRST NAMED INVENTOR
Bo Lonnerdal
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.
212561-0001-00-US-517559 7465
EXAMINER
COX,AMBERM
ART UNIT PAPER NUMBER
1793
NOTIFICATION DATE DELIVERY MODE
12/03/2018 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):
DBRIPDocket@dbr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL
AND APPEAL BOARD
Ex parte BO LONNERDAL, OLLE HERNELL,
LARS-BORJE SJOBERG, and CATHARINA TENNEFORS
Appeal2017-007585
Application 14/391,494
Technology Center 1700
Before MICHAEL P. COLAIANNI, CHRISTOPHER C. KENNEDY, and
JANEE. INGLESE, Administrative Patent Judges.
COLAIANNI, Administrative Patent Judge.
DECISION ON APPEAL
Appeal2017-007585
Application 14/391,494
Appellants appeal under 35 U.S.C. § 134 the final rejection of claims
1--4, 6-17, and 20-27. We have jurisdiction over the appeal pursuant to
35 U.S.C. § 6(b).
We AFFIRM.
The appealed claims are directed to a composition, method of using
and method of making the composition ( Claims 1, 22, 23, and 26). The
composition is said to give the formula-fed infant, for example, a growth
pattern, metabolic burden and level of blood cholesterol similar to breastfed
children and also at the same time reduces risk of morbidity during infancy
as well as later in life (Spec. 4: 18-21 ).
Claim 1 is illustrative:
A nutritional composition, as a ready-to-use product or a ready-to-
use product reconstituted with water from a manufactured powder,
compnsmg:
sweet whey solids in an amount of 32-40 kg/I 000kg dry powder
composition;
sodium caseinate in an amount of 4.6-5.7 kg/lOOOkg dry powder
composition;
skim milk solids in an amount of 66-81 kg/ 1 OOOk dry powder
composition;
whey protein concentrate solids rich in phospholipids in an amount of
47-58 kg/1000 kg dry powder composition; and
cream solids in an amount of 117-143 kg/I 000 kg dry powder
composition, wherein:
a total energy content is 67 kcal/I 00 ml or lower,
a protein content is 1.25 g/100 ml or lower,
an energy content from protein is 7,2-8.4 percentage of the total
energy content of the nutritional composition,
an energy content from fat is 49 percentage or more of the total
energy content of the nutritional composition,
a medium chain fatty acid content comprises 8 to 10 carbons and is
less than 3 weight % of total amount of fatty acids,
a sialic acid content is 10-25 mg/I 00 ml,
a cholesterol content is 7-9 mg/100 ml [[and]]
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a sphingomyelin content is 9-15 mg/I 00 ml, and
gluco macro peptide (GMP), wherein said GMP has not been removed
or depleted from the nutritional composition.
Appellants appeal the following rejections:
1. Claims 1--4, 6-13, 15-17, and 20-27 are rejected under 35 U.S.C.
§ I03(a) as unpatentable over Zwijssen '192 (WO 2007/073192 A2;
June 28, 2007) in view of Zwijsen '149 (US 2010/0038149 Al; Mar.
18, 2010), Rueda (US 2008/0003330 Al; Jan. 3, 2008), and Carlson
(US 2004/0265462 Al; Dec. 30, 2004).
2. Claim 14 is rejected under 35 U.S.C. § I03(a) as unpatentable over
Z wij ssen '192 in view of Z wij sen '149, Rueda, Carlson, and
"Breastfeeding: A Guide to the Medical Profession" (Biochemistry of
Human Milk pp. 120-122) ..
FINDINGS OF FACT & ANALYSIS
Appellants argue the subject matter common to claims 1 and 26 only
(App. Br. 3-15). We select claim 1 as representative of the group. Any
claim not argued separately will stand or fall with the sole independent claim
1.
Appellants argue that no combination of the applied references
discloses or suggests each and every element of claim 1 (App. Br. 9).
Appellants contend that none of the prior art teaches or suggests any amount
of cream solids in the composition (App. Br. 9). Appellants argue that
although cream solids are a product of milk fat, milk fat found in a
composition could be coming from many sources besides cream solids (App.
Br. 9). Appellants contend that cream solids comprise minerals, lactose and
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Application 14/391,494
protein, in addition to milk fat (Reply Br. 2). Appellants argue that cream
solids are not merely fat that rises to the top of milk (Reply Br. 2).
The Examiner finds Zwijssen '192 teaches milk fat as a source of
cholesterol in the composition (Final Act. 7). The Examiner finds that
Appellants disclose in the Specification that adding milk fat to the
composition by the addition dairy cream increases cholesterol in the
composition (Ans. 23). The Examiner finds that Zwijssen '192 's disclosure
of adding milk fat to adjust cholesterol content of the composition comports
with Appellants' disclosure that cream is the source of the milk fat (Ans.
23). The Examiner finds that cream is well known as being the fat that
naturally rises to the top of milk, and thus is milk fat (Ans. 23). The
Examiner further finds that it would have been obvious to use the solid,
powder form of the cream/milk fat because Z wij ssen ' 192 teaches that the
composition may be in powder form (Final Act. 8).
Although Appellants contend that cream solids contain materials other
than milk fat, Appellants have not proffered any evidence to substantiate the
mere attorney argument. Moreover, given that milk fat originates from the
same source as cream (i.e., cow's milk), cream or milk fat would have been
expected to have the same or similar components as milk ( e.g., lactose,
protein, and minerals). Appellants have not established that the cream solids
differ in any meaningful way from the milk fat added to Z wij ssen ' 192 's
composition.
Appellants argue that none of the references disclose or suggest the
claimed amounts of sweet whey solids, sodium caseinate, skim milk solids,
whey protein concentrate solids rich in phospholipids, or cream solids (App.
Br. 10). Appellants contend that none of the references disclose the amount
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Application 14/391,494
of cream solids or sweet whey solids (App. Br. 10). Appellants argue that
the amounts of sodium caseinate disclosed in Zwijssen '192 and Zwijsen
'149 are five to ten times greater than the ranges in claim 1 (App. Br. 10).
Appellants contend that Rueda's disclosed amount of skim milk solids is
more than double the upper limit of the range recited in claim 1 (App. Br.
10). Appellants argue that only Rueda teaches an amount of whey protein
concentrate with a high concentration of phospholipids within the claimed
range (App. Br. 10). Appellants argue that the guidance provided by the
references would have led to optimizing values for the components outside
the claimed ranges (App. Br. 10).
Contrary to Appellants' arguments, the Examiner's rejection of claim
1 is based upon the combined teachings of Zwijssen '192, Zwijsen '149,
Rueda, and Carlson (Final Act. 3). Accordingly, Appellants' argument that
certain references include concentrations of components outside the claimed
ranges does not take into account what the combined teachings of the
references would have suggested to the ordinarily skilled artisan. The
Examiner finds that Zwijssen '192's composition would have been modified
by the teachings of Zwijsen '149, Rueda and Carlson in order to achieve a
composition that desirably prevents diseases later in life, and mimics the
amounts of the components found in human breastmilk in order to provide
proper development to the infant (Final Act. 5-6). The Examiner finds that
the concentrations in the claims would have been arrived at through routine
experimentation because no criticality has been shown by Appellants for the
various claimed concentration ranges (Ans. 26). Appellants do not dispute
the lack of showing of criticality in the amounts of the components.
Z wij ssen ' 192 's teaching about the amount of casein added to the
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Application 14/391,494
composition is merely a preference. Similarly, Rueda's teachings regarding
the skim milk solids are only an example and not limiting on Rueda's
disclosure. In other words, non-preferred embodiments with differing
amounts of casein or skim milk solids are not excluded from Zwijssen
'192's or Rueda's disclosure.
Appellants argue that there is no teaching in any of the applied
references to remove the gluco macro peptide ( GMP) from the composition
(App. Br. 11). Appellants argue that contrary to the Examiner's finding that
Zwijssen '192's teaching is merely a preference for removal of the GMP, the
references ( other than Carlson that is silent on the matter) teach away from
not removing or depleting the GMP (App. Br. 12).
Zwijssen '192, Zwijsen '149 and Rueda teach a preference for
removing the gluco macro peptide (GMP) (Zwijssen '192, 18:32-34;
Zwijsen '149, ,r 32, Rueda ,r 42). The Examiner finds that a preference for
removal of the GMP includes a non-preferred embodiment where the GMP
is not removed (Ans. 28). A mere preference does not constitute a teaching
away from the non-preferred embodiment. In re Susi, 440 F .2d 442, 446 n.3
( CCP A 1971). The prior art does not discourage one of ordinary skill in the
art from not removing the GMP if the result from removing the GMP is only
a less preferred embodiment. In re Gurley, 27 F.3d 551, 553 (Fed. Cir.
1994).
Appellants argue that there is no reason to combine the teachings of
the references absent impermissible hindsight (App. Br. 13). Appellants
contend that because a conclusion of obviousness requires predictability, it
would not have been obvious to modify the formulas other than to match the
values presented in the claims (App. Br. 13). Appellants contend that the
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lack of predictability in selecting the concentrations of the various
components is shown by the comparison of Formula A (i.e., a composition
falling within the claims) to Control A and breastmilk fed group (App. Br.
14). Appellants contend that the table on page 28 of the Specification shows
that the Formula A values produce a composition that provides similar
growth and metabolic values as breastmilk-fed infants (App. Br. 15).
Appellants contend that small changes in the ingredients and amounts of
ingredients have unpredictable results in the growth and development of
infants (App. Br. 15).
Contrary to Appellants' arguments, the Examiner's rationale for
modifying Zwijssen '192's composition is to provide a composition similar
to breastmilk that aids in the development and growth of an infant while
preventing diseases later in life (Final Act. 5---6, 8, 9). The Examiner is not
relying impermissible hindsight but rather the teachings of the references
regarding the various components of a nutritional composition. The
Examiner relies on optimizing the concentration of the various components
to arrive at the claimed invention. Appellants have not shown reversible
error in that determination.
The Examiner finds that Appellants' evidence in the table on page 28
of the Specification is limited to a single example within the claims and is
not commensurate in scope with the claims (Ans. 21). We agree. To be
probative of non-obviousness, the evidence of unexpected results must be
commensurate in scope with the claims. In re Clemens, 622 F .2d 1029,
1035 (CCPA 1980). Although the ranges are narrow as argued by
Appellants, there is no trend shown by Appellants with the data (Reply Br.
2). We agree with the Examiner that the argument and evidence in the
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Specification table on page 28 are not sufficient to establish unexpected
results.
On this record, we affirm the Examiner's§ 103 rejections (1) and (2).
DECISION
The Examiner's decision is affirmed.
No time period for taking any subsequent action in connection with this
appeal may be extended under 37 C.F.R. § 1.136(a) (1 )(iv).
ORDER
AFFIRMED
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