Ex Parte Ochial et al

Patent Trial and Appeal BoardMar 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. Â§ 134. The Examiner has rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. Â§ 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. Â§ 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 3 Appeal2017-009776 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, 4 Appeal2017-009776 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 5 Appeal2017-009776 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 6 Appeal2017-009776 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 7