Ex Parte Le-Henand et al

Patent Trial and Appeal Board

Jan 6, 2016

12444936 (P.T.A.B. Jan. 6, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/444,936 12/09/2009
29157 7590
K&L Gates LLP-Chicago
P.O. Box 1135
CHICAGO, IL 60690
01/08/2016
FIRST NAMED INVENTOR
Herve Le-Henand
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.
3712036-01404 3834
EXAMINER
YOO, HONG THI
ART UNIT PAPER NUMBER
1793
NOTIFICATION DATE DELIVERY MODE
01/08/2016 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 HERVE LE-HENAND, 1
Frarn;ois Murbach, Michael Jedwab, Claudia Roessle,
Luc Cynober, and Agathe Raynaud-Simon
Appeal2014-000933
Application 12/444,936
Technology Center 1700
Before TERRY J. OWENS, MARK NAGUMO, and
N. WHITNEY WILSON, Administrative Patent Judges.
NAGUMO, Administrative Patent Judge.
DECISION ON APPEAL
Herve Le-Henand, Frarn;ois Murbach, Michael Jedwab, Claudia
Roessle, Luc Cynober, and Agathe Raynaud-Simon (''Nestec") timely
appeal under 35 U.S.C. § 134(a) from the Final Rejection2 of claims 1, 3-5,
1 The real party in interest is listed as Nestec S.A. ("Nestec"). (Appeal
Brief, filed 10 June 2013 ("Br."), 2.)
2 Office action mailed 24 January 2013 ("Final Rejection"; cited as "FR").
Appeal2014-000933
Application 12/444,936
- . - - . - - . '1 -- - - - - - - -
8-17, and 19-21.-' We have jurisdiction. 35 U.S.C. § 6. We affirm
substantially for reasons well-stated by the Examiner.
OPINION
A. Introduction 4
The subject matter on appeal relates to a composition for "enteral
feeding" ('tube-feeding') (Spec. 1 [0002]) an "elderly patient," which
the '936 Specification defines as "an adult patient sixty-five years of age or
older who cannot receive nutrition through a normal diet but who is normo-
metabolic (i.e., not suffering from a metabolic disorder)." (Id. at 4 [0020].)
The composition is to be administered at least once per day, "long-term,"
i.e., for a period greater than one month (30 days). (Id. at 3 [0019].) The
composition is said to have been designed to optimize the glycemic response
in elderly patients, i.e., to avoid repeated episodes of hyperglycemia
(excessive blood glucose); which is said to be associated with vascular;
cardiovascular, and kidney issues. (Id. at 4 [0021]-[0022].) This goal is
said to be obtained, in part, by providing decreased carbohydrate intake,
with the addition of fructose, fibers, and chromium. (Id. at 5 [0027]-
6 [0030].)
3 Remaining co-pending claims 22-30 have been withdrawn from
consideration to by the Examiner. (Br., Claims App.; the Examiner's
summary (FR 1, §§ 5, 5a) misstates the claims rejected, as well as those
withdrawn from consideration.)
4 Application 12/444,936, Long-term feed-elderly, filed 9 December 2009,
as the national stage of PCT /EP07 /61098, filed 17 October 2007, which
claims the benefit of a provisional application filed 9 October 2006. We
refer to the "'936 Specification," which we cite as "Spec."
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Application 12/444,936
Claim 1 is representative of the dispositive issues and reads:
A method for providing tube-fed nutrition to an
elderly patient comprising the steps of:
administering to an elderly patient at least once a day
long term through a tube a nutritional product comprising:
a source of protein that comprises 14 to 20% by caloric
content of the product, at least 50% by weight of the
protein source comprising whey protein;
a source of carbohydrates that comprises 10 to 45% by
caloric content of the product;
a source of lipids that comprises 30 to 45% by caloric
content of the product, the lipids comprising
40 to 60% by weight mono-unsaturated fats,
saturated fatty acids are not more
than 1.1 grams per 100 kcal of the product, and
from 0.4 to 2 percent by weight of the lipids are
eicosapentaenoic acid;
a source of dietary fiber that provides
10 to 25 grams per liter of the product;
8.0 to 18.0 micrograms of chromium per 100 kcal of the
product;
at least 0.5 micrograms of vitamin D per 100 kcal of the
product; and
the nutritional product has an energy density
of 0.8 to 1.3 kcal/ml.
(Claims App., Br. 13; some indentation, paragraphing' and emphasis added.)
The other independent claim, claim 13, is similar in the specifically
disputed limitations. (Id. at 14.)
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Appeal2014-000933
Application 12/444,936
The final limitations recited in claims 1 and 13, related to energy
density, were incorporated from dependent claims 10 and 21, respectively,
which were canceled. 5
The Examiner maintains the following grounds of rejection6 :
A. Claims 1, 3-5, 8, 9, and 11-17 stand rejected under
35 U.S.C. § 103(a) in view of the combined teachings of
Ammann, 7 Green, 8 Lin, 9 Antoku, 10 and Burkhardt. 11
Al. Claims 9 and 20 stand rejected under 35 U.S.C. § 103(a) in
view of the combined teachings of Ammann, Green, Lin,
Antoku, Burkhardt, and Ernest. 12
5 Amendment filed 8 April 2013; approved for entry by the Examiner on
that day (Advisory Action, mailed 8 April 2013 ("Advisory")).
6 Examiner's Answer mailed 18 July 2013 ("Ans.").
7 Christina Ammann et al., High fibre high calorie liquid or powdered
nutritional composition, WO 2005/013721 Al (2005) (assigned to Nestec,
SA; present co-inventor Claudia Roessle is listed as a co-inventor on
Ammann).
8 Ceiwen Jane Green et al., Nutritional composition containing fibres, U.S.
Patent No. 5,792,754 (1998).
9 Paul M. Lin et al., Method for providing nutrition to elderly patients, U.S.
Patent No. 5,686,429 (1997) (assigned to Nestec, SA).
10 Yasunobu Antoku et al., Fat composition/or oral or enternal [sic:
enteral] administration and hexacosanoic acid depressant, U.S. Patent
No. 6,867,234 B2 (2005).
11 Peter Burckhardt et al., eds., Nutritional Aspects of Osteoporosis, 2d Ed.,
Elsevier Academic Press (2004) (excerpts from a Google® webpage).
12 Stephen P. Ernest, Enternal [sic: enteral]formulation, U.S. Patent
Application Publication 2004/0067224 Al (2004).
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Application 12/444,936
B. Findings of Fact
Findings of fact throughout this Opinion are supported by a
preponderance of the evidence of record.
The Federal Circuit has explained that on appeal, the appellant must
not only show the existence of error, but also that the error was harmful
because it affected the decision below. In re Chapman, 595 F.3d 1330, 1338
(Fed. Cir. 2010), quoting Shinseki v. Sanders, 556 U.S. 396, 409 (2009)
("the burden of showing that an error is harmful normally falls upon the
party attacking the agency's determination.").
Initially, we find that Nestec presents substantive arguments for the
patentability of claims 1 and 9 only. Thus, claims 3-5, 8, 9, and 11-17 stand
or fall with claim 1, and claim 20 stands or falls with claim 9.
Nestec urges that the Examiner failed to establish a motivation to
combine the teachings of the various references, citing, in particular,
Ammann, Lin, and Antoku. In particular, Nestec argues that the Examiner
found that Ammann teaches a nutritional composition having an energy
density of 1.4 to 1.8 kcal/ml, above the required range of 0.8 to 1.3 kcal/ml
recited in claim 1. (Br. 8, 11. 9-11.) The Examiner failed, in Nestec's view,
to establish a reason to use the composition taught by Lin for total enteral
nutritional support, which, the Examiner found (FR 12, 11. 10-16) has a
preferred caloric density of 1.2 kcal/ml, within the range required by
claim 1. The Examiner found that the value of 1.4 kcal/ml reported by
Ammann was "close to the endpoint range of cited range of0.8
to 1.3 kcal/ml," and concluded that the difference was not patentably
distinct because it would have been obvious to use the caloric density taught
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Application 12/444,936
by Lin for a successful nutritional composition in the nutritional composition
taught by Ammann. (Advisory 3, 11. 1-20.)
We do not find Nestec's summary dismissal of the Examiner's
detailed factual findings (which Nestec does not contest) and conclusion of
law persuasive. Nestec has not directed our attention to any credible
evidence of record that indicates that those of skill in the art would have
disagreed with the Examiner's conclusion that energy densities
of 1.4 kcal/ml and 1.2 or 1.3 kcal/ml were substantially the same for
nutritional compositions disclosed as being suitable for "total enteral
nutritional support" (Lin, col. 6, 11. 35-36). 13
We are not persuaded of harmful error in the Examiner's findings or
conclusions regarding the obviousness of the recited energy density of the
nutritional composition.
In a similar conclusory manner, Nestec criticizes the Examiner's
conclusion that it would have been obvious to use fatty acids in amounts of
not more than 1.1 grams per 100 kcal of the product, based on the teachings
of Lin. (Br. 8, para. bridging 8-9.) Again, Nestec does not contest the
Examiner's detailed factual findings (FR 6, 11. 1-11 ), and merely criticizes
13 In this regard, we note that both Ammann and Lin are assigned to Nestec,
and Ammann shares a common inventor with the present application.
Therefore, we do not find it credible that Nestec is unaware of the teachings
of these references. In particular, we are concerned that Nestec has
overlooked or failed to cite Ammann's disclosure that the nutritional
composition has an energy content of 1.3-1.8 kcal/ml (Ammann, Abstract,
3d line; 9, 11. 1-2; claim 1 at 16, 1. 6.) Amman's disclosure is not necessary
to the Examiner's determination that the preferred range of 1.4--1.8 kcal/ml
is close to the range required by claim 1; but the disclosure supports strongly
the Examiner's determination.
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Application 12/444,936
the conclusion of obvious as lacking motivation. The similarity of the
products, as explained supra, however, would have provided a reasonable
expectation of success based on the similar uses, which Nestec has not
disputed.
Nestec also criticizes the Examiner's conclusion that it would have
been obvious to use eicosapentaenoic acid (fish oil) in amounts taught by
Antoku, because the Examiner failed to establish a motivation to combine
the teachings. Again, Nestec does not dispute the Examiner's factual
findings regarding the amounts of eicosapentaenoic acid suggested by
Antoku for use in compositions for oral or enteral administration for the
benefit ofhexacosanoic acid depression "with an object of producing an
aging-inhibitory effect on cell membranes" (Antoku, col. 1, 11. 13-15).
N estec' s similar summary criticisms (Br. 11) of the Examiner's
findings and conclusions regarding the teachings of Ernest regarding
lycopene and lutein, which are required by claims 9 and 20, are similarly
unpersuasive.
In summary, given the detailed and specific findings of fact made by
the Examiner, which Nestec has not criticized for their accuracy or
pertinence, 14 we are not persuaded of harmful error in the Examiner's well-
stated findings of fact and conclusions of law.
14 Nestec has not criticized the Examiner's findings or analysis of Green and
the combination of those teachings with relevant teachings of Ammann.
(FR 3-5.)
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Application 12/444,936
C. Order
It is ORDERED that the rejection of claims 1, 3-5, 8-17, and 19-21 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).
AFFIRMED
tc
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