Ex Parte Miller et al

Patent Trial and Appeal Board

May 22, 2017

13386209 (P.T.A.B. May. 22, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/386,209 03/05/2012 Kevin Burke Miller 3712036-01492 3655
29157 7590 05/24/2017
K&T Oates T T .P-Phiraan
EXAMINER
P.O. Box 1135
CHICAGO, IL 60690
BOWERS, ERIN M
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
05/24/2017 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 KEVIN BURKE MILLER, INGO ARNE JURK and
ZAMZAM KABIRY ROUGHEAD
Appeal 2017-0004351
Application 13/386,209
Technology Center 1600
Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and
JOHN G. NEW, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to method of attenuating the loss
of functional status in an elderly individual. The Examiner rejected the
claims under 35 U.S.C. § 103 as obvious. We have jurisdiction under 35
U.S.C. § 6(b). The rejections are affirmed.
1 The Appeal Brief (“Appeal Br.”) 2 lists Nestec S.A. as the real-party-in-
interest.
Appeal 2017-000435
Application 13/386,209
STATEMENT OF THE CASE
Appellants appeal from the Examiner’s rejection of claims 1, 2, 4, 6—
17, 27, 33, and 34. The claims are rejected under seven grounds of rejection
under pre-AIA 35 U.S.C. § 103(a). Ans. 3, 9, 14, 18, 25, 29, and 31. In
each of the rejections, the Examiner cited Evans (J. Nutr., 127: 998S—1003S,
1997), Leclerc (French patent application FR 2882896 Al, pub. Sept. 15,
2006), and Campbell (J. Int. Soc. Sports Nutr., 4(8): 1—7, 2007), with
additional publications cited to meet specific limitations in the dependent
claims. The principal basis of all the rejections is the same, and Appellants
provided the same arguments for each rejection. See Appeal Br. 9—19.
Consequently, we considered all seven rejections together, focusing the
discussion on Evans, Leclerc, and Campbell which are common to all seven
rejections.
Claims 1 and 34 are the only independent claims on appeal. Claim 1
reads as follows:
1. A method of attenuating the loss of functional status in an
elderly individual, the method comprising the elderly individual
consuming a nutritional composition and performing an
exercise regimen comprising endurance training and resistance
training, the elderly individual consumes the nutritional
composition in one or more doses less than one hour before the
elderly individual performs the endurance training for a time
period of at least 10 minutes, the nutritional composition
comprising: whey protein, Vitamin D and at least one
component selected from the group consisting of: creatine;
antioxidants; bioactives; lycopene; pycnogenol; quercetin;
genistein; soy; epigallocatechin; green tea; lipoic acid; Alpha-
Lipoic Acid; X-tocopherol; dihydroascorbic acid; Vitamin C;
ubiquinone; Coenzyme Q10; Leucine; Leucine metabolites;
alpha-hydroxyisocaproate; beta-hydroxy beta-methylbutyrate;
ketoisopcaproate; branched chain amino acid(s) (BCAA), a
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BCAA precursor; a BCAA metabolite; a BCAA-rich protein; a
protein manipulated to enrich the BCAA content; and
nucleotides.
Claim 34 differs from claim 1 in requiring “the elderly individual
consumes the nutritional composition in one or more doses less than fifteen
minutes before the elderly individual performs the endurance training”
instead of “less than one hour” as in claim 1. (Emphasis added.)
FINDINGS OF FACT
Evans
FF1
High intensity resistance training (above 60% of the 1 repetition
maximum) causes large increases in strength in the elderly, and
resistance training significant increases muscle size. Resistance
training also significantly increases energy requirements and
insulin action of the elderly ... In a population of 100 nursing
home residents, a randomly assigned high intensity strength
training program resulted in significant gains in strength and
functional status.
Evans, Abstract.
FF2
A large percentage of homebound elderly people consuming
their habitual dietary protein intake (0.67 g mixed protein • kg'1
• d'1) have been shown (Bunker et al. 1987) to be in negative
nitrogen balance. Inadequate dietary protein intake may be an
important cause of sarcopenia. The compensatory response to a
long-term decrease in dietary protein intake is a loss in lean
body mass.
Id. at 1000S (first col.).
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Campbell
FF3
When supplements are ingested, we recommend that the protein
contain both whey and casein components due to their high
protein digestibility corrected amino acid score and ability to
increase muscle protein accretion.
Campbell 4.
FF4
Hence, previous research has indicated that ingesting a protein
source that is rich in essential amino acids and is readily
digestible immediately before and following exercise training is
beneficial for increasing muscle mass, recovery following
exercise, and sustaining immune function during high-volume
training periods.
It is the position of the International Society of Sport Nutrition
that exercising individuals should consume high quality protein
within the time period encompassing their exercise session (i.e.
before, during, and after).
Id.
FF5
An increasing amount of literature suggests that of the three
BCAAs, leucine appears to play the most significant role in
stimulating protein synthesis . . .
Because BCAAs have been shown to aid in recovery processes
from exercise such as stimulating protein synthesis, aiding in
glycogen resynthesis, as well as delaying the onset of fatigue
and helping maintain mental function in aerobic-based exercise,
we suggest consuming BCAAs (in addition to carbohydrates)
before, during, and following an exercise bout.
Id. at 4, 5.
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Leclerc
FF6
Leclerc teaches a food composition to limit frailty in the elderly
(see entire document, including page 1, paragraph 3). The
prevention of sarcopenia, which is the loss of muscle mass,
requires the maintenance of adequate protein intake (page 3,
line 22; cf. claims 6 and 7). Whey provides a good protein
source for the prevention of sarcopenia because whey proteins
are rich in branched-chain amino acids, such as leucine (page 3,
lines 29-33; cf. claims 2 and 10 and line 10 of claims 1 and 34).
Glutamine is added to the composition to protect the intestinal
mucosa and maintain immune function (page 3, lines 34-38; cf.
claim 9). Vitamin D and minerals are also important for
slowing sarcopenia and maintaining immune function (page 4,
lines 3—8; cf. claim 11 [“... wherein the nutritional composition
reduces protein catabolism that comprises muscle breakdown”]
and line 6 of claims 1 and 34 [“... vitamin D”]). Leclerc teaches
a preferred composition comprising 11. 7 g of whey protein and
7 g of pea protein; the other components of the composition
have negligible caloric value (vitamins, etc.) (page 9, lines 17—
21).
Final Act. 7.
Specification
FF7
[0038] Clinical studies have suggested that vitamin D
insufficiency is associated with poor lower extremity
performance. Several randomized, controlled intervention trials
have found that vitamin D supplementation in amounts that
bring the treated group's mean serum 25-OH Vitamin D level to
66-84 nmol/L improves lower extremity muscle performance in
the elderly. Additionally, serum 25-OH Vitamin D was the
common contributor to physical fitness indices (androidal fat
mass, lean mass, balance, handgrip strength) in healthy
postmenopausal women. The proposed nutritional formula will
seek to significantly augment the circulating levels of serum 25-
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FF8
OH Vitamin D in the elderly utilizing a concentrated, low
volume approach.
[0036] Somatopause is the process of reduced growth hormone
and IGF-1 as we age. This reduction in important anabolic
hormones leads to reduced lean body mass (sarcopenia) and
bone mineral density over time (osteopenia, osteoporosis).
Certain dietary factors such as high protein diets as well as and
dietary Zn and Cu have been shown to help increase serum
IGF. Furthermore, the composition provides other important
nutrients such as high levels of vitamin D which synergistically
increases the efficacy of other anabolic hormones such as
insulin (note that as we age, we also become insulin resistant).
Therefore, the unique combination of these key nutrients will
synergistically create a favorable physiological response
leading to improved overall musculoskeletal health. The
combination of such formulation with resistance exercise will
also lead to synergistic benefits not realized with an equivalent
amount of essential amino acids, or other key ingredients alone.
FF9
[0042] The prior art teaches that dietary interventions, including
elevated protein, have not been entirely successful in improving
physical function. Nutrition is a stimulant of protein synthesis,
but inadequate to make a clinically relevant difference. The
combination of specific exercise program and specific
nutritional intervention suggests the benefits of each treatment
modality may be synergistic.
REJECTIONS
Claim 1 is directed to a “method of attenuating the loss of functional
status in an elderly individual.” The method comprises: (1) “consuming a
nutritional composition” and (2) “performing an exercise regimen
comprising endurance training and resistance training.”
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The nutritional composition is consumed “in one or more doses less
than one hour before the elderly individual performs the endurance training
for a time period of at least 10 minutes.”
The composition comprises: (1) whey protein, (2) vitamin D; and (3)
at least component selected from a list of components. Component (3)
includes leucine and branched chain amino acids (BCAA).
Claim 34 is substantially the same as claim 1, but requires the
composition to be consumed less than fifteen minute before the elderly
person engages in endurance training.
The Examiner found Evans teaches the benefits of endurance and
resistance training in the elderly, meeting step (2) of claim 1. Ans. 4. The
Examiner also found that Evans identified inadequate dietary protein as a
cause of sarcopenia in the elderly. Id. Sarcopenia is the decline in muscle
mass. The Examiner found that Leclerc teaches a nutritional composition to
limit frailty in the elderly which comprises: (1) whey to prevent sarcopenia,
(2) vitamin D for slowing sarcopenia and maintaining immune function, and
(3) leucine and BCAA, meeting all three components of the claimed
nutritional composition. Id. at 5.
To meet the requirement of claim 1 that the nutritional composition is
consumed “in one or more doses less than one hour before the elderly
individual performs the endurance training,” the Examiner cited Campbell
for its teaching that exercising individuals should consume high quality
protein within the time period encompassing their exercise session. Id. at 6.
The Examiner found it would have been obvious to one of ordinary
skill in the art to have administered Leclerc’s nutritional composition as part
of Evans’ endurance training “because Evans teaches that inadequate dietary
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protein intake may be an important cause of sarcopenia, and Leclerc teaches
a protein-rich dietary supplement, that included vitamin D to prevent
sarcopenia.” Id. at 7. The Examiner also found it obvious to have
administered the nutritional composition before exercise because Campbell
teaches the benefit of ingesting protein immediately before exercise. Id. at
9.
Appellants contend that “no evidence or reasoning has been provided
by the Patent Office that the skilled artisan would have had any expectation
that including vitamin D with the protein consumed less than one hour
before the endurance training would have conferred any particular
desirable property relative to consumption of the vitamin D at other times.”
Appeal Br. 8. Appellants acknowledge that the cited prior art would have
“motivated the skilled artisan to provide a nutritional composition so that the
elderly individual consumes whey protein less than one hour before the
elderly individual performs endurance training,” but contend the motivation
would not have extended to vitamin D. Id. Appellants also argue that
“there is no suggestion whatsoever in Evans, Leclerc, Marshall and
Campbell that the timing of consumption of vitamin D has any significance
with respect to preventing sarcopenia.” Id. at 9.
Appellants contend:
The combination of such formulation with resistance exercise
will also lead to synergistic benefits not realized with an
equivalent amount of essential amino acids, or other key
ingredients alone. See specification, pages 8—9, paragraph 36.
Appeal Br. 6. Appellants also cited paragraph 42 of the Specification as
describing synergy. Id.
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DISCUSSION
Appellants contend that one of ordinary skill in the art would not have
had reason to administer the vitamin D one hour (claim 1) or 15 minutes
(claim 34) before engaging in endurance exercise.
We do not agree with Appellants’ reasoning. Evans expressly teaches
“Inadequate dietary protein intake may be an important cause of sarcopenia”
in elderly people. FF2. Campbell teaches that “ingesting a protein source
that is rich in essential amino acids and is readily digestible immediately
before and following exercise training is beneficial for increasing muscle
mass, recovery following exercise, and sustaining immune function during
high-volume training periods.” FF4 (emphasis added). Thus, there was
adequate reason, supported by a preponderance of the evidence to have
ingested protein “immediately before . . . exercise training.” FF4; Appeal
Br. 8. Thus, there is clear reason to have administered a nutritional
composition comprising whey within the time periods encompassed by
claims 1 and 34.
Feclerc teaches a nutritional composition comprising whey, vitamin
D, and leucine, all three components of the claimed nutritional composition.
FF6. Administering Feclerc’s composition with whey for its known benefit
for muscle, including treating sarcopenia (FF2, FF4), would have resulted in
administering vitamin D, as well. In view of the teaching of Feclerc of a
formula containing whey, vitamin D, and other components within the scope
of claim 1, it is commonsense to administer the entire formula immediately
before exercise as taught by Campbell (FF4), rather than just the whey
protein, as a matter of convenience and to facilitate compliance.
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Appellants contend that synergistic benefits were realized. Appeal Br.
6. However, no objective evidence of synergy was provided nor of what
compositions(s) achieved such synergy. Paragraphs 36 and 42 cited by
Appellants as evidence of synergy do not describe the content of the
composition attributed to synergy and the paragraphs use the terms “will’
and “may” to describe synergy (FF8, FF9), suggesting that experiments may
not have even been performed. Paragraph 36 (FF8) also refers to dietary Zn
and Cu as being involved in the synergy, but the claims do not require their
presence.
An applicant cannot prove unexpected results with attorney
argument and bare statements without objective evidentiary
support. See In re Lindner, 59 C.C.P.A. 920, 457 F.2d 506, 508
(CCPA 1972); In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir.
1997) (“attorney argument [is] not the kind of factual evidence
that is required to rebut a prima facie case of obviousness”); In
re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995) (“It is well settled
that unexpected results must be established by factual evidence.
Mere argument or conclusory statements ... [do] not suffice.”)
(quoting In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)).
CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342(Fed. Cir. 2003).
In this case, in view of the lack of objective evidence of synergy, we
conclude that Appellants did not rebut the evidence of obviousness.
The argument that the timing of the vitamin D one hour before, or 15
minutes before, endurance training is not persuasive because Appellants did
not demonstrate the criticality of such timing, namely that administering the
vitamin D more than an hour before endurance training did not achieve
synergistic benefits, while administering it less than an hour before training
did. Moreover, it was known in the art that vitamin D, and serum levels of
it, improved muscle performance (FF6, FF7), providing reason to have
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determined the optimal times for administering vitamin D to obtain those
circulating levels.2
A declaration under 37 C.F.R. § 1.132 was provided by Zamzam K.
Roughead, a co-inventor of the claimed subject matter (“Roughead Decl.”).
Dr. Roughead, who holds a doctoral degree in human nutrition, testified in
her declaration:
The Patent Office seems to overlook that most individuals
consume different nutritional compositions throughout the day;
even if an elderly individual would have consumed the
combination of whey protein and vitamin D sometime during
the day, that does not establish that the elderly individual would
have consumed the same composition less than one hour before
the elderly individual performs endurance training. The
teachings of Evans, Leclerc and Marshall merely would have
motivated the skilled artisan to provide a nutritional
composition so that the elderly individual consumes whey
protein less than one hour before the elderly individual
performs endurance training, not vitamin D.
Roughead Decl. 15.
There is no suggestion whatsoever in Evans, Leclerc and
Marshall that the timing of consumption of vitamin D has any
significance with respect to preventing sarcopenia.
Id. at | 6.
Dr. Roughead’s testimony is not persuasive.
First, as already discussed, the criticality of the timing of vitamin D
has not been demonstrated. To the extent that specific serum levels of
vitamin D are necessary to benefit muscle performance, the Specification
admits that such levels were known prior to the invention (FF7), making it
2 “[Wjhere 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.” In re Aller, 220 F.2d 454, 456 (CCPA 1955).
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obvious to have optimized the timing of vitamin D consumption to achieve
such known levels.
Second, while it may be correct that individuals consume nutritional
compositions throughout the day, Leclerc teaches a composition with whey,
vitamin D, and the third component required by the claim; it was known that
ingestion of whey protein immediately before exercise is beneficial (FF2,
FF4), providing reason to ingested Leclerc’s composition before the
endurance training of Evans (FF1) to achieve such benefit. It would have
been commonsense to consume Leclerc’s composition immediately before
exercise to achieve the temporal benefit of whey (FF4) and the convenience
and compliance benefits of consuming a single composition with all the
nutritional components known to prevent sarcopenia in the elderly.
Claim 14
Claim 14 depends from claim 1, and further recites that “the
nutritional composition consists of the whey protein, the Vitamin D and the
at least one component.” (Emphasis added.)
Appellants contend:
However, Leclerc teaches that ingredients in the dietary
supplement additional to whey protein, vitamin D and leucine
are essential. For example, Leclerc teaches that the supplement
of “the invention” includes ginsensosides, a seaweed extract,
polyphenols and carotenoids. See Leclerc, machine translation,
page 6, third paragraph from bottom.
Reply Br. 7.
The Examiner had fully responded to the argument regarding claim
14:
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it would have been obvious to one of ordinary skill in the art to
include only [whey protein, vitamin D, and leucine] ... in the
composition of Leclerc because Leclerc teaches that whey
protein, which contains leucine, and vitamin D are both
beneficial for the prevention of sarcopenia, and one of ordinary
skill in the art would be motivated to omit additional
components that may trigger allergies or other deleterious
reactions.
Ans. 32.
Appellants contend that such modification “would change the
principle of operation of the references,” making it non-obvious (Reply Br.
7), but failed to explain how omission of the additional components would
change the way Leclerc’s composition operated to improve sarcopenia.
Appellants also did not identify a defect in the Examiner’s rationale, which
we conclude is reasonable, particularly as each of whey, vitamin D, and
leucine are characterized as significant for muscle supplementation (FF2,
FF3, FF5, FF6, FF7), providing express reason to administer these
component to an elderly person to prevent sarcopenia.
SUMMARY
For the foregoing reasons, all obviousness rejections of claim 1, 14,
and 34 are affirmed. Dependent claims 2, 4, 6—13, 15—17, 27, and 33 were
not argued separately and fall with the independent claims. 37 C.F.R. §
41.37(c)(iv)(l).
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)(l)(iv).
AFFIRMED
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