Ex Parte Ikeda et al

Patent Trial and Appeal BoardDec 17, 2018

13407578 (P.T.A.B. Dec. 17, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/407,578 02/28/2012 29880 7590 12/19/2018 FOX ROTHSCHILD LLP PRINCETON PIKE CORPORATE CENTER 997 LENOX DRIVE BLDG. #3 LAWRENCEVILLE, NJ 08648 FIRST NAMED INVENTOR Takeshi Ikeda 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. 105055.00005 3751 EXAMINER DRAPER, LESLIE A ROYDS ART UNIT PAPER NUMBER 1629 NOTIFICATION DATE DELIVERY MODE 12/19/2018 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): ipdocket@foxrothschild.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte TAKESHI IKEDA, MAMI NEBASHI, KOJI MORISHITA, and RYUSUKE NAKAGIRI 1 Appeal2017-009910 Application 13/407,578 Technology Center 1600 Before ERIC B. GRIMES, MICHAEL J. FITZPATRICK, and JOHN G. NEW, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL 1 Appellants state that the real party-in-interest is Kyowa Hakko Bio Co., Ltd. App. Br. 2. Appeal2017-009910 Application 13/407 ,578 SUMMARY Appellants file this appeal under 35 U.S.C. Â§ I34(a) from the Examiner's Final Rejection of claim 2 as unpatentable under 35 U.S.C. Â§ I03(a) as being obvious over the combination of Komatsu et al. (US 2010/0168040 Al, July 1, 2010) ("Komatsu"), Greenhaff et al. (US 6,143,784, November 7, 2000) ("Greenhaff'), and S. Ando et al., Effects of Acute Exercise on Visual Reaction Time, 29 INT. J. SPORTS MED. 994--98 (2008) ("Ando"). Claim 2 also stands provisionally rejected as unpatentable under the nonstatutory doctrine of obviousness-type double patenting over claims 1-6, 8, and 16 of US Ser. No. 13/508,163 (the "'163 application") in combination with Komatsu, Greenhaff, and Ando. Claim 2 stands further rejected as unpatentable under the nonstatutory doctrine of obviousness-type double patenting over claims 1-3 and 6-9 of US 9,119,416 B2 (September 1, 2015) (the "'416 patent") in combination with Greenhaff and Ando. We have jurisdiction under 35 U.S.C. Â§ 6(b). We AFFIRM. NATURE OF THE CLAIMED INVENTION Appellants' invention is directed to a vision performance enhancing composition and method to enhance visual performance using alanylglutamine, or a salt thereof, as an active ingredient. Abstr. REPRESENTATIVE CLAIM Claim 2 is the sole claim on appeal and recites: 2 Appeal2017-009910 Application 13/407 ,578 2. A method of improving the ability to see objects during sports activities involving moderate to heavy exercise, comprising the step of administering an amount of 500 to 3,000 mg of alanylglutamine or a salt thereof per day during the sports activities to a person having decreased ability to see objects due to the sport activities. App. Br. 8. ISSUES AND ANALYSES We are persuaded by, and expressly adopt, the Examiner's findings, reasoning, and conclusion that Appellants' claims are primafacie obvious over the combined cited prior art. We address the arguments raised by Appellants below. A. Rejection of claim 2 under 35 U.S.C. Â§ 103(a) Issue 1 Appellants argue the Examiner erred because none of the references, individually or in combination, teach administration of alanylglutamine to an adult subject during exercise. App. Br. 4. Analysis The Examiner finds that Komatsu teaches a method for remedying muscle fatigue comprising administering alanylglutamine to a subject in need of such a remedy. Non-Final Office Action of July 25, 2014 (the "Non-Final Action") 3 (citing Komatsu ,r,r 12, 25-26). The Examiner finds Komatsu teaches that the dose and administration frequency of the remedy may vary, but generally the alanylglutamine ( or salt thereof) is administered once to several times per day in an amount of 5-10,000 mg, preferably 50- 3 Appeal2017-009910 Application 13/407 ,578 5,000 mg, and more preferably 500-3,000 mg/day for an adult. Id. (citing Komatsu ,r 39). The Examiner finds that Komatsu provides examples of administration of alanylglutamine in healthy male subjects either before exercise or after exercise, in which administration of alanylglutamine provided relief of muscle fatigue or muscle pain. Id. ( citing Komatsu Ex. I, ,r,r 41--43, Table 1). The Examiner further finds that Komatsu does not explicitly teach: (1) administration specifically during sport activities involving moderate to heavy exercise to a person "having decreased ability to see objects due to the sport activities"; or (2) the claimed preamble effect of "improving the ability to see objects during sport activities involving moderate to heavy exercise." Non-Final Act. 3. However, the Examiner finds that Greenhaff teaches a method for reducing muscle fatigue in humans during exercise via ingestion or infusion of pyruvate either prior to or during exercise. Non-Final Act. 3 (citing Greenhaff col. 1, 11. 3-5, 32-36, 43--44). The Examiner also finds that Ando teaches that moderate to severe exercise decreases the ability to capture visual information from the periphery of the visual field. Non-Final Act. 3 (citing Ando Abstr., 997). The Examiner therefore concludes that a person of ordinary skill in the art would have had a reasonable expectation of success in administering alanylglutamine, known to be effective in reducing muscle fatigue and pain in humans performing strenuous exercise, as disclosed by Komatsu, during the performance of strenuous exercise, because Greenhaff teaches that administration of an anti-fatigue compound during performance of exercise activities effectively reduced muscle fatigue in humans during exercise. 4 Appeal2017-009910 Application 13/407 ,578 Non-Final Act. 3--4. The Examiner further concludes that a person of ordinary skill would have been motivated to combine the teachings if the references to minimize muscle fatigue for the purpose of prolonging the subject's ability to exercise without (or with minimal) muscle fatigue or lassitude. Id. at 3. Appellants argue that none of the references cited by the Examiner teaches or suggests, either individually or in combination, administration of alanylglutamine to an adult subject during exercise. App. Br. 4. Appellants assert that Greenhaff, which is cited by the Examiner as teaching that a reduction in muscle fatigue in humans performing exercise could be effected by administering a muscle fatigue-reducing therapy during the performance in exercise, does not teach alanylglutamine. Id. Rather, Appellants argue, Greenhaff teaches administration of pyruvate to reduce muscle fatigue during exercise. Id. According to Appellants, the teachings of Greenhaff are specifically directed to reducing muscle fatigue during exercise associated with the lag in activation of mitochondrial energy production at the beginning of exercise. Id. ( citing Greenhaff col. 1, 11. 9--16). Appellants contend that Greenhaff summarizes its teachings as comprising "a method for reducing muscle fatigue during exercise, the method comprising increasing the concentration of TCA cycle intermediates in the muscle mitochondria by the administration of pyruvate to the body." App. Br. 4--5 (quoting Greenhaff col. 1, 11. 31-35). Appellants argue that Greenhaff neither teaches nor suggests any other composition besides pyruvates that could be expected to function in this way, and observe that alanylglutamine is not an intermediate of the TCA cycle. Id. at 5. Appellants assert that although the Examiner characterizes both pyruvate 5 Appeal2017-009910 Application 13/407 ,578 and alanylglutamine as "muscle fatigue-reducing remedies," the mechanisms by which each substances affects human subjects are not equivalent, as is known to those of ordinary skill in the art. Id. Appellants contend that there would therefore have been no reason for a person of ordinary skill in the art to substitute pyruvate with alanylglutamine because they are not equivalents for simple substitution. Id. Appellants proffer another prior art reference, P.K. Koh-Banerjee et al., Effects of Calcium Pyruvate Supplementation During Training on Body Composition, Exercise Capacity, and Metabolic Responses to Exercise, 21 NUTRITION 312-19 (2005) ("Koh-Banerjee"). App. Br. 5. According to Appellants, Koh-Banerjee teaches that administration of pyruvate during exercise may produce the therapeutic effect described in Greenhaff (i.e., reduction of muscle fatigue). Appellants argue that, in the study taught by Koh-Banerjee, pyruvate was administered to women going through a thirty- day program of resistance training and walking, and teaches that "results indicated that [pyruvate] supplementation does not significantly affect maximal exercise capacity, ventilator anaerobic threshold, or time to exhaustion." Id. Appellants contend that these findings indicate that [pyruvate] supplementation during training does not appear to be an effective ergogenic aid in women who initiate training." Id. (quoting Koh- Banerjee 318). Therefore, Appellants argue, although Greenhaff mentions (but does not exemplify) the administration of pyruvate during exercise, Koh-Banerjee discloses actual data from experiments involving pyruvate and its insignificant effect on exercising subjects. Id. Appellants contend that, in view of the teachings of Koh-Banerjee, a person of ordinary skill in the art would not be motivated to administer pyruvate, let alone the 6 Appeal2017-009910 Application 13/407 ,578 alanylglutamine of Komatsu, during exercise in order to reduce muscle fatigue. Id. We are not persuaded by Appellants' arguments. Komatsu expressly teaches that administration of alanylglutamine, in the claimed dosage range, prior to and/ or after exercise is successful in reducing muscle fatigue and/ or muscle pain. See Komatsu ,r 39, Table 1. Greenhaff teaches that administration of pyruvate, another muscle fatigue-relieving agent during exercise, succeeds in reducing muscle fatigue: According to the present invention there is provided a method of reducing muscle fatigue during exercise, the method comprising increasing the concentration of [tricarboxylic acid] cycle intermediates in the muscle mitochondria by the administration of pyruvate to the body. The pyruvate could be ingested in the form of a tablet, sustained release capsule, or powder. In the latter case the powder could be dissolved prior to ingestion. The pyruvate could be administered prior to or during exercise. For example, a pyruvate solution could be used by cyclists in drink bottles whilst cycling. Greenhaffcol. 1, 11. 31-35, col. 2, 11. 23-29 (emphasis added). Appellants argue that there would be no reason for a person of ordinary skill in the art to combine the teachings of Komatsu with those of Greenhaff, because pyruvate is a constituent of the tricarboxylic acid cycle in muscle and alanylglutamine is not, and that, therefore, the two compositions work by different mechanisms. However, Komatsu and Greenhaff teach that alanylglutamine and pyruvate are, respectively, both useful in the reduction of muscle fatigue despite having different mechanisms by which this is accomplished. See Komatsu ,r 13; Greenhaff col. 1, 11. 31-35. As such, Komatsu and Greenhaff are analogous art and can 7 Appeal2017-009910 Application 13/407 ,578 properly be combined. See In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004) (holding that the initial test for analogous art inquires not only whether the references address the same problem as the claimed invention, but also whether they are both from the same field of endeavor as the claimed invention). Consequently, the question properly before us is whether a person of ordinary skill in the art would have found it obvious to combine the teachings of Komatsu, which teaches that administration of alanylglutamine before and/or after exercise, with the teachings of Greenhaff, which teaches that administration of an anti-fatigue agent during exercise can reduce muscle fatigue. We agree with the Examiner that it would have been obvious to combine the references. Appellants' reliance upon the fact that alanylglutamine and pyruvate act to alieve muscle fatigue via different cellular mechanisms is misplaced. It is not necessary that the two compounds act via the same metabolic mechanisms, rather, the question is whether they have the same end effect. i.e., the reduction of muscle fatigue, and whether a compound that can reduce muscle fatigue when administered prior to and/ or after exercise can also effectively reduce muscle fatigue when administered during exercise. See In re Keller, 642 F.2d 413,425 (C.C.P.A. 1981): The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. 8 Appeal2017-009910 Application 13/407 ,578 We agree with the Examiner that a person of ordinary skill in the art would have found it obvious to administer alanylglutamine during exercise, as taught by Greenhaff, given that Komatsu teaches that administration before and or after exercise is effective in producing that effect. Nor are we persuaded by Appellants' reliance upon Koh-Banerjee. Koh-Banerjee is limited to a study of pyruvate administration and not administration of alanylglutamine, and its ability to predict the efficacy of administration of alanylglutamine during exercise is not strong, particularly given that Komatsu teaches that administration of alanylglutamine prior to and/or after exercise is effective in reducing muscle fatigue. See Komatsu Table 1. Furthermore, a proposed combination of the references need not provide an absolute certainty of success, merely a reasonable expectation. See In re Langi, 795 F.2d 887, 897 (Fed. Cir. 1985) (holding that only a reasonable expectation of success, not absolute predictability, is necessary for a conclusion of obviousness). We agree with the Examiner that the combined teachings of Komatsu and Greenhaff would together give a person of ordinary skill in the art a reasonable expectation of success of reducing muscle fatigue by administering alanylglutamine during exercise, the teachings of Koh-Banerjee with respect to pyruvate administration notwithstanding. We are consequently not persuaded by Appellants' arguments. Issue 2 Appellants argue that the Examiner's conclusion that the claims are prima facie obvious over the combined cited prior art is rebutted by Appellants' evidence of unexpected results. App Br. 6. 9 Appeal2017-009910 Application 13/407 ,578 Analysis Appellants argue that even if, arguendo, the Examiner has established a prima facie case of obviousness, that conclusion can be successfully rebutted by a showing of an unexpected advantage of the claimed invention compared with the closest prior art. App. Br. 6 ( citing MPEP Â§ 2145). Appellants point to Example 5 of the Specification, which discloses that visual reaction time was significantly better following administration of alanylglutamine compared to no water and no alanylglutamine (p = 0.014 for low dose, p = 0.018 for high dose). Id. (citing Spec. Fig. 2). Furthermore, Appellants observe that the Specification further discloses that physical reaction time was significantly greater for low dose alanylglutamine (p = 0.032) compared to no water/no alanylglutamine. Id. Appellants contend that these results are statistically significant and are neither taught nor suggested by Komatsu, Greenhaff, or Ando. Id. We are not persuaded by Appellants' argument. Appellants' burden is to show that their results are surprising or unexpected compared to those taught by the closest prior art. See In re Baxter Travenol Labs., 952 F .2d 388, 392 (Fed. Cir. 1991) (holding that: "[W]hen unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art"). Appellants provide no such comparison. Example 5 of Appellants' Specification demonstrates that: "Visual reaction time (Figure 2) was significantly better following AG 1 [low dose: 1 g alanylglutamine/500 ml)] (p=0.014) compared to DHY(No water and no [ alanylglutamine] consumed during trial), and a trend toward a similar response (p=0.018) was noted between AG2 [high dose: 2 g per 500 ml] and 10 Appeal2017-009910 Application 13/407 ,578 DHY." Spec. 8. 2 However, Appellants provide no comparison with the effects of administration of alanylglutamine administered before and/or after exercise, as taught by Komatsu, with the effects of administering it during exercise as claimed. Appellants' Specification appears to disclose a statistically significant effect of administering alanylglutamine upon visual performance during exercise, but absent a comparison to the teachings of the nearest prior art, it is impossible to determine whether these results would have been unexpected or surprising to a person of ordinary skill in the art. Put another way, because Komatsu, the nearest prior art, teaches administering alanylglutamine in the claimed dosage range before and after exercise, the burden falls on Appellants to demonstrate that the results obtained from administering alanylglutamine during exercise are significantly different in kind, such that they would be unexpected, from the results obtained from administering the composition prior to and/or after exercise. See Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) (holding that unexpected results that are probative of nonobviousness are those that are "different in kind and not merely in degree from the results of the prior art" (citation omitted)). Appellants have not met this burden, and we consequently affirm the Examiner's rejection of the claims. 2 Appellants' Specification lacks page numbers. We have therefore constructively numbered them consecutively, beginning with the title page as page 1. 11 Appeal2017-009910 Application 13/407 ,578 B. Rejection of claim 2 under obviousness-type double patenting over the '163 application, Komatsu, Greenhaff, and Ando Appellants argue that, for the same reasons they have argued supra, the '163 application, Komatsu, Greenhaff, and Ando, individually or in combination, fail to teach or suggest administration of alanylglutamine to an adult subject during exercise. App. Br. 6. We disagree, for the reasons we have explained supra, and we consequently affirm the Examiner's rejection upon this ground. C. Rejection of claim 2 under obviousness-type double patenting over the '416 patent, Komatsu, Greenhaff, and Ando Appellants argue that, for the same reasons they have argued supra, the '416 patent, Komatsu, Greenhaff, and Ando, either individually or in combination, fail to teach or suggest administration of alanylglutamine to an adult subject during exercise. App. Br. 7. We disagree, for the reasons we have explained, and we consequently affirm the Examiner's rejection upon this ground. DECISION The Examiner's rejection of claim 2 under 35 U.S.C. Â§ 103(a) is affirmed. The Examiner's rejections of claim 2 under the nonstatutory doctrine of obviousness-type double patenting are affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED 12