Ex Parte Ochial et al

Patent Trial and Appeal Board

Mar 1, 2019

13508163 (P.T.A.B. Mar. 1, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/508, 163 12/19/2012
29880 7590 03/05/2019
FOX ROTHSCHILD LLP
PRINCETON PIKE CORPORATE CENTER
997 LENOX DRIVE
BLDG. #3
LAWRENCEVILLE, NJ 08648
FIRST NAMED INVENTOR
Masayuki Ochial
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.
105055.00006 4885
EXAMINER
DABKOWSKI, ERINNE R
ART UNIT PAPER NUMBER
1654
NOTIFICATION DATE DELIVERY MODE
03/05/2019 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):
ipdocket@foxrothschild.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MASA YUKI OCHIAL, KOJI MORISHITA, MIRO KOMATSU,
and YOICHIRO SUGIMURA
Appeal2017-009776
Application 13/508, 163 1
Technology Center 1600
Before DEMETRA J. MILLS, ERIC B. GRIMES, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b ).
We reverse.
1 The real party in interest is Kyowa Hakko Bio Co., Ltd. App. Br. 2.
Appeal2017-009776
Application 13/508,163
NATURE OF THE INVENTION
"The present invention relates to a method of enhancing endurance of a
human subject through administration of alanyl-glutamine or alanyl-
glutamine salt." Spec. 1; Abstract. Specification examples are provided
showing the use of of alanyl-glutamine or alanyl-glutamine salt during
hydration stress. Spec. 7. In the Specification examples, endurance or
"time to exhaustion was determined as the time that the subject could no
longer maintain the workload and/or reach[ed] volitional exhaustion." Spec.
10.
STATEMENT OF CASE
The following claim is representative.
1. A method of enhancing endurance during exercise of a
dehydrated human subject, comprising the step of:
administering an effective amount of alanyl-glutamine or
a salt thereof to the dehydrated human subject in a single dose,
wherein the dehydrated human subject is at least
dehydrated at the beginning of the exercise by a loss of more
than 1.5% of the dehydrated human subject's baseline body
mass, and
the exercise elicits the dehydrated human subject a
workload of at least 75% of the dehydrated human subject's
V02 max.
Cited References
Brouns EP O 540 462 Al
2
June 10, 1992
Appeal2017-009776
Application 13/508,163
Jes B. Sorensen et al., Exercise on Prescription: Trial Protocol and
Evaluation of Outcomes, 7 BMC Health Services Research 36 (2007)
http://www.biomedcentra1.com/l472-6963/7/36 ("Sorensen").
William Mathieu Cheramie, Effects of Aerobic and Anaerobic Training
Protocols on 4000M Track Cycling Time Trial, Louisiana State University,
1---60 (2004) ("Cheramie").
Rehydrate Electrolyte Replacement Drink Sustain Optimal Hydration,
Advocare, AdvoCare International, L.P.
Rick Contrata, How to Recognize the Signs and Symptoms of Overtraining
(Jan. 5, 2015), http://www.howtodothings.com/sports-recreation/how-to-
reco gnize-the-signs-and-symptoms-o f-overtraining ("Contrata").
Horleys, Dehydration & Fluid Replacement, (searched Jan. 5, 2015)
httn://www .horleys.com/Resources/Resources/Resources%20-
%20Dehydration%20%26%20 Fluid%20Replacement (2014) ("Horleys").
Grounds of Rejection
Claims 1-6, 8, and 16 are rejected under pre-AIA 35 U.S.C.
§ 103(a) as being unpatentable over by Brouns, Sorensen, Cheramie,
Advocare, Contrata, and Horleys.
FINDINGS OF FACT
The Examiner's findings of fact are set forth in the Answer, at pages
3-12.
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F .2d 1422, 1427
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Application 13/508,163
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
Obviousness Rejection
The Examiner finds that
Brouns teaches a method of administering alanyl-glutamine to a
human subject in need of enhancing endurance ( claim 1 and claim
17). Brouns specifically teaches that alanyl-glutamine can be
administered to people involved in endurance exercise, physical
activity or suffering from overtraining. People that are involved in
endurance exercise, physical activity or suffering from overtraining
are considered a population in need of enhancing endurance since they
exercise.
Final Act. 3. Brouns also discloses the intake of a sports drink comprising
the L-glutamine source ( alanyl-glutamine) for rehydration and energy supply
(Brouns, page 3, lines 16-20). Final Act. 4.
According to the Examiner, the difference between the reference and
the instant claims is that Brouns is silent to a dehydrated human subject at
the beginning of exercise by a loss of more than 1.5% of the baseline body
mass. Ans. 4.
The Examiner finds that Advocare teaches an electrolyte replacement
drink comprising L-Alanyl-L-Glutamine. Ans. 4. The Examiner finds that
Contrata teaches that one of the major symptoms associated with
overtraining in athletes is dehydration. Dehydration affects blood viscosity,
proper organ function and distribution of nutrients (page 2, under Biological
Symptoms). Ans. 4. Horleys teaches that hypo hydration, a state of
decreased body water content, occurs when body fluid losses are not fully
replaced. Ans. 4. Horleys further discloses,
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Application 13/508,163
Hypohydration prior to exercise can alter circulatory,
thennoregulatory and metabolic functions as a result of progressive
dehydration due to excessive sweat loss during exercise. The
consequences of dehydration include reduced training capacity,
reduced sports performance, and compromised thermoregulation and
cardiovascular functions (page 1, Exercise and Dehydration section).
Ans. 4. The Examiner concludes that,
It would have been obvious at the time of the invention to try
treating dehydrated over-trained individuals with at least 2% or more
dehydration level as taught by Contrata with the alanyl-glutamine
dipeptide of Brouns. One of ordinary skill in the art would have been
motivated to do so given that Brouns teaches treatment of over-trained
individuals and a major complication with over-trained individuals is
dehydration. There is further motivation to treat dehydrated over-
trained individuals with the composition of Brouns given that
compositions comprising alanyl-glutamine will promote hydration via
enhancing electrolyte and water absorption as well as promoting
higher serum bioavailability and absorption of L-glutamine.
Furthermore, there is reasonable expectation of success since
promoting hydration in dehydrated over-trained individuals at the
beginning of exercise will improve training capacity, sports
performance, thermoregulation and cardiovascular function. There is
further reasonable expectation of success given that Broun[ s] teaches
administering alanyl-glutamine to over-trained individuals and
promoting hydration.
Ans. 4--5.
Appellants contend that Brouns discloses that "'L-Alanyl-L-glutamine
supplementation did not influence time to exhaustion during the final
exercise bout (8-10 min) at 90% Wmax-' Brouns, page 5, lines 13-15
(emphasis added)." App. Br. 4. Appellants further argue that, "the human
subject of Brouns is a person dehydrated less than 1.16 % of the person's
body weight. In contrast, the dehydrated human subject of the pending
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Application 13/508,163
claims is at least dehydrated at the beginning of the exercise by a loss of
more than 1.5% of the dehydrated human subject's baseline body mass."
App. Br. 5. Appellants argue that Figs. 2a and 2b of the Specification
support a finding of unexpected results in this case. App. Br. 6.
ANALYSIS
We do not find that the Examiner has provided a preponderance of the
evidence to support a prima facie case of obviousness.
Claim Interpretation
"enhancing endurance"
We interpret the claim 1 preamble term "enhancing endurance", in
view of the Specification, to mean "increasing the time to exhaustion."
Spec. 10, 14; Spec.Figs.2a,2b.
We do not find that the preponderance of the evidence supports the
Examiner's findings in this case. In particular, Brouns discloses that
glutamine supplementation in the form of L-alanyl-L-glutamine "did not
influence time to exhaustion" in Experiments 1 and 2. Brouns 4-5.
The Examiner responds to Appellants' argument, stating that
Though the one Example provided by Brouns suggest that
the alanyl-glutamine supplementation did not affect time to
exhaustion, the overall teachings of Brouns do not teach away from
enhancing endurance during exercise. Furthermore, as stated by
Appellant, the athletes in the Examples of Brouns are not dehydrated
at least 1.5% or at a level that perturbs performance as taught by
Contrata, thus, this could be a possible explanation why the desired
effect was not seen in the one example. Nevertheless, there are many
different ways to measure enhancing endurance via different
exercises. Brouns reducing to practice one example that does not
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Application 13/508,163
show the desired effect of enhancing time to exhaustion in a human
subject does not teach away from using glutamine supplementation
for enhancing endurance in dehydrated individuals as taught by the
combined references.
Ans. 10.
We do not find that the Examiner has sufficiently responded to
Appellants' arguments that Brouns "did not influence time to exhaustion"
and thus does not disclose the invention as claimed. Brouns 4--5; App. Br. 4.
The Examiner has not explained why one of ordinary skill in the art, aware
of Brouns, would have understood that the administration of L-alanyl-L-
glutamine to a dehydrated person, influenced the time of exhaustion of a
dehydrated person, consistent with the claimed subject matter. The
Examiner appears to further rely on Contrata for administering L-alanyl-L-
glutamine to a dehydrated, overtrained person (Ans. 5), but nowhere has the
Examiner indicated how the combined references show enhancement of
endurance (a decrease in the time to exhaustion) in dehydrated persons.
In addition, the Examiner failed to address, in a specific manner,
Appellants' unexpected results arguments and data set forth in the
Specification, Figs. 2a and 2b. App. Br. 6-7.
CONCLUSION OF LAW
The preponderance of the evidence does not support the Examiner's
obviousness rejection, which is reversed.
REVERSED
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