5965596 et al.Download PDFPatent Trials and Appeals BoardOct 8, 201990013923 - (D) (P.T.A.B. Oct. 8, 2019) Copy Citation 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. 90/013,923 03/21/2017 5965596 028284.0105X6US (01684) 3442 127044 7590 10/08/2019 Porzio, Bromberg & Newman P.C. 1200 New Hampshire Ave., NW Suite 710 Washington, DC 20036 EXAMINER KUGEL, TIMOTHY J ART UNIT PAPER NUMBER 3991 MAIL DATE DELIVERY MODE 10/08/2019 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte NATURAL ALTERNATIVES INTERNATIONAL, INC. Patent Owner and Appellant ____________ Appeal 2019-005175 Reexamination Control 90/013,923 Patent 5,965,596 Technology Center 3900 ____________ Before ROMULO H. DELMENDO, RICHARD M. LEBOVITZ, and RAE LYNN P. GUEST, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL This appeal involves claims to a method of regulating hydronium ion concentrations in a human tissue comprising providing an amount of beta- alanine to blood or blood plasma effective to increase beta-alanylhistidine dipeptide synthesis in the human tissue. The Examiner rejected the claims as unpatentable under 35 U.S.C. §§ 102(b) and 103(a). Pursuant to 35 U.S.C. § 134(b), Appellant1 appeals the rejection of the claims. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 Appellant identifies the real party in interest as Natural Alternatives International, Inc. Appeal Br. 1. Appeal 2019-005175 Reexamination Control 90/013,923 Patent 5,965,596 2 STATEMENT OF THE CASE This appeal involves US 5,965,596 (“the ʼ596 patent”), which issued October 12, 1999. A Request for Ex Parte Reexamination of the ʼ596 patent was submitted by a third-party requester, identified as Hoffmann & Baron, L.L.P., on March 21, 2017 under 35 U.S.C. §§ 301–307 and 37 C.F.R. § 1.510. The patent expired August 12, 2017 (Remarks by Applicant filed Sept. 25, 2017). This case was heard on August 20, 2019. A transcript of the oral hearing will be entered into the record in due course. Under 37 C.F.R. § 41.67(c)(1)(ii), Appellant is required to make a statement in the Appeal Brief “identifying by application, patent, appeal, interference, or trial number all other prior and pending appeals, interferences, trials before the Board, or judicial proceedings known to appellant, the appellant’s legal representative, or assignee which may be related to, directly affect or be directly affected by or have a bearing on the Board's decision in the pending appeal.” There were two appeal proceedings before the Patent Trial and Appeal Board that this panel knows of which involve beta-alanine and beta-alanylhistidine, and which have the same real- party-in-interest as in this proceeding, and thus are pertinent to this appeal, and indeed, one of the Decisions is cited below. These proceedings, listed as follows, were not identified by Appellant in the Appeal Brief: 1) Appeal 2015-000225, Reexamination Control 95/002,001, Patent 8,067,381 B1; and 2) Appeal 2016-000745, Reexamination Control 95/002,048, Patent 8,129,422 B2. Appeal 2019-005175 Reexamination Control 90/013,923 Patent 5,965,596 3 Rejections Claims 1–11 are pending. The claims are the original patent claims and have not been amended. The claims stand finally rejected by the Examiner as follows: 1. Claims 1, 2, 7, and 11 under pre-AIA 35 U.S.C. § 102(b) as anticipated by Asatoor.2 Ans. 3. 2. Claims 1, 2, 7, and 11 under pre-AIA 35 U.S.C. § 103(a) as obvious over Asatoor in combination with Bauer.3 Ans. 5. 3. Claims 3–6 under pre-AIA 35 U.S.C. § 103(a) as obvious over Asatoor as applied to claims 1, 2, 7, and 11 above, in combination with Birch,4 Balsom,5 or Casey.6 Ans. 6. 4. Claims 3–6 under pre-AIA 35 U.S.C. § 103(a) as obvious over Asatoor in combination with Bauer as applied to claims 1, 2, 7, and 11 above, in further combination with Birch, Balsom, and Casey. Ans. 7. 2 Asatoor et al., “Intestinal absorption of carnosine and its constituent amino acids in man,” Gut, 1970, 11:250-254. 3 Bauer et al., “Biosynthesis of carnosine and related peptides by skeletal muscle cells in primary culture,” Eur. J. Biochem., 1994, 219:43-47. 4 Birch et al., “The influence of dietary creatine supplementation on performance during repeated bouts of maximal isokinetic cycling in man,” Eur. J. Appl. Physiol., 1994, 69:268-270. 5 Balsom et al., “Creatine supplementation and dynamic high-intensity intermittent exercise,” Scand. J. Med. Sci. Sports, 1993, 3:143-149. 6 Casey, et al., “Creatine ingestion favorably affects performance and muscle metabolism during maximal exercise in humans,” Am. J. Physiol., July 1996, 271:E31-E37. Appeal 2019-005175 Reexamination Control 90/013,923 Patent 5,965,596 4 5. Claim 8 under pre-AIA 35 U.S.C. § 103(a) as obvious over Asatoor as applied to claims 1, 2, 7, and 11 above, in combination with Smith.7 Ans. 8. 6. Claim 8 under pre-AIA 35 U.S.C. § 103(a) as obvious over Asatoor in combination with Bauer as applied to claims 1, 2, 7, and 11 above, in further combination with Smith. Ans. 9. 7. Claims 9 and 10 under pre-AIA 35 U.S.C. § 103(a) obvious over Asatoor as applied to claims 1, 2, 7, and 11, in combination with Katsoyannis.8 Ans. 10. 8. Claims 8–10 under pre-AIA 35 U.S.C. § 103(a) as obvious over Asatoor in combination with Bauer as applied to claims 1, 2, 7, and 11, in combination with Katsoyannis. Ans. 10. Claim 1, the only independent claim in the ’596 patent, is reproduced below: 1. A method of regulating hydronium ion concentrations in a human tissue comprising: providing an amount of beta-alanine to blood or blood plasma effective to increase beta-alanylhistidine dipeptide synthesis in the human tissue; and exposing the tissue to the blood or blood plasma, whereby the concentration of beta-alanylhistidine is increased in the human tissue. 7 U.S. Patent 5,122,515 issued to Smith et al. on June 16, 1992. 8 U.S. Patent 5,208,217 issued to Katsoyannis et al. on May 4, 1993. Appeal 2019-005175 Reexamination Control 90/013,923 Patent 5,965,596 5 1. ANTICIPATION REJECTION BASED ON ASATOOR Findings of Fact (“FF”) Asatoor FF1. “Five normal adults were investigated, each individual ingesting carnosine and equivalent amounts of a mixture of β-alanine and L-histidine after an overnight fast.” Asatoor 250 (“Methods”). FF2. Carnosine is a dipeptide of β-alanine and L-histidine. Ans. 3 (fn. 2). Carnosine satisfies the limitation of claim 1 of “beta- alanylhistidine.” FF3. Asatoor teaches that carnosine was administered at 0.286 m mol/kg body weight corresponding to 20 m mole per standard 70 kg male. Asatoor 251. FF4. Asatoor teaches that β-alanine and L-histidine “were taken together in an amount which would be produced after hydrolysis of the above dose of carnosine.” Asatoor 251. FF5. “The two tolerance tests in each subject were carried out at intervals of at least two weeks.” Asatoor 250–251. FF6. Asatoor reported that “[p]eak concentrations of β-alanine occurred in the [blood basal serum] sample taken after 30 minutes.” Asatoor 251 (“Results”). FF7. Asatoor did not determine the concentration of carnosine in a tissue after administration of the β-alanine. Appeal 2019-005175 Reexamination Control 90/013,923 Patent 5,965,596 6 Rejection Claim 1 requires 1) providing beta-alanine to blood or blood plasma; and 2) exposing tissue to the blood or blood plasma such that “the concentration of beta-alanylhistidine is increased in the human tissue.” The Examiner found that Asatoor’s administration of beta-alanine by ingestion meets the first step of claim 1 of “providing an amount of beta- alanine to blood or blood plasma.” Ans. 3–4; FF1–FF4. The Examiner found that the ’596 patent discloses that the concentration of beta-alanine limits the synthesis of beta-alanine-histidine (“beta-alanylhistidine” in the claims). Ans. 4. Based on this finding, the Examiner found that the second step of the claim is met because “[t]herefore, any increase in beta-alanine in muscle–and therefore any concentration in the claimed composition–will be effective to increase beta-alanylhistidine dipeptide synthesis [in the human tissue] and . . . meet the claim limitation.” Id. Discussion Asatoor does not disclose that the ingested beta-alanine increases the tissue concentration of beta-alanylhistidine as required by the second step of claim 1. FF7. However, the Examiner made the determination that Asatoor would meet this limitation of the claims based on the finding that the synthesis of beta-alanylhistidine is limited by the concentration of beta- alanine; that is, increasing the concentration of beta-alanine in blood, when administered by Asatoor to humans, would be expected to increase the concentration of beta-alanylhistidine in human tissue9 as required by the 9 The Examiner understood “human tissue” to be a muscle tissue. Ans. 4. Appeal 2019-005175 Reexamination Control 90/013,923 Patent 5,965,596 7 claim because concentration is the rate-limiting step in the synthetic reaction. It is well-established when the PTO “has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter [may] be an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on.” In re Swinehart, 439 F.2d 210, 212–13 (CCPA 1971). As explained In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. See In re Ludtke, supra. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. See In re Brown, 459 F.2d 531, 59 CCPA 1036 (1972). When the Examiner establishes a reasonable basis for finding that the cited prior art, when carried out, meets all the limitations of the claim, even if not recognized at time, the burden shifts to the Appellant to provide rebuttal evidence. The applicant has the burden of coming forward with evidence in rebuttal, when the prior art includes a method that appears, on its face, to be capable of producing the claimed composition. This burden may be met by presenting sufficient reason or authority or evidence, on the facts of the case, to show that the Appeal 2019-005175 Reexamination Control 90/013,923 Patent 5,965,596 8 prior art method would not produce or would not be expected to produce the claimed subject matter. In re Kumar, 418 F.3d 1361, 1368 (Fed. Cir. 2005). In this case, Appellant provided several lines of rebuttal evidence that Asatoor’s method would not have necessarily, or inherently, resulted in increasing the concentration of beta-alanylhistidine in human tissue as required by the claims. This evidence, which is described below, includes 1) Examples 1 and 4 of the ’596 patent, 2) declarations by Roger Charles Harris, Ph.D. (Harris Declaration of October 29, 2012, “Harris Decl.”) and Jay R. Hoffman, Ph.D. (Hoffman 2 Declaration of July 13, 2017, “Hoffman 2 Decl.”), and 3) post-filing publications. Findings of Fact ’596 patent examples Example 1 FF8. Example 1 of the Specification describes the “effect of supplementation of a normal diet with multiple daily doses of beta-alanine and L-histidine on the carnosine concentration in type I, IIA, and IIB skeletal muscle fibers of thoroughbred horses.” ’596 patent, col. 6, ll. 24– 27. FF9. “Dietary supplementation was begun on day 1 of the protocol and discontinued at the end of day 30.” Id. at col. 6, ll. 47–48. FF10. After 30 days, the Specification discloses that “[d]ifferences in carnosine concentrations within fiber types before and after supplementation were established.” Id. at col. 7, ll. 16–17. FF11. The Specification discloses: Appeal 2019-005175 Reexamination Control 90/013,923 Patent 5,965,596 9 Following thirty days of beta-alanine and L-histidine supplementation the mean carnosine concentration was increased in type IIA and IIB fibers in all six horses. These increases were statistically significant in seven instances. The increase in mean carnosine concentration in type IIB skeletal muscle fibers was statistically significant in five out of six horses. The increase in mean carnosine concentration in type IIA skeletal muscle fibers was statistically significant in two out of six horses. Id. at col. 8, ll. 36–45. Example 4 FF12. Example 4 of the Specification describes the “effect of administration of three doses of 40 milligrams per kilogram body weight of beta-alanine per day (i.e., administered in the morning, noon, and at night) for 2 weeks on the carnosine content of muscle” and other parameters. ’596 patent, col. 12, ll. 46–49. FF13. Six normal male subjects were recruited into the studies. Id. at col. 12, ll. 51–52. The subjects were administered beta-alanine for 15 days. Id. at col. 14, ll. 1–2. FF14. On day 14, a muscle biopsy was obtained. Id. at col. 14, ll. 3– 8. FF15. The Specification discloses that “[t]here was no apparent change in the muscle carnosine content in the muscle of the six subjects biopsied.” Id. at 14:24–25. FF16. Figure 10 of the ’596 patent shows serum beta-alanine concentration increased after its administration and then declined. Appeal 2019-005175 Reexamination Control 90/013,923 Patent 5,965,596 10 Second Declaration by Jay R. Hoffman, Ph.D. FF17. Dr. Hoffman stated: Dr. Harris’ major invention was the supplementation of the diet by providing unnaturally high levels of the non-essential amino acid beta-alanine in the blood over a long period of time to increase the amount of beta-alanyl-L-histidine (carnosine) in the muscle tissue well above natural homeostatic levels. Hoffman 2 Decl. ¶ 7. FF18. Dr. Hoffman stated: Beta-alanine is . . . ordinarily synthesized in the liver and to some extent stored in the liver. . . . Although it was known that beta-alanine is synthesized and stored in the liver, no one knew how to unnaturally force the liver to make or release more so that it could be used by the body to increase the content of muscle carnosine in muscle. Before the invention, no one knew how to cause any increase in beta-alanyl- L-histidine synthesis or to subsequently increase the amount of beta-alanyl-L- histidine retained in the muscle. Hoffman 2 Decl. ¶ 8. FF19. Based on Example 4 in the Specification, Dr. Hoffman stated: It would have been clear at the time of the invention, and now would be clear to one of skill in the art after reading the specification, that a one-time administration of a composition containing beta-alanine would be an insufficient amount to increase athletic performance because there would be no measurable increase in beta-alanyl-L-histidine synthesis that would lead to such increased performance. Hoffman 2 Decl. ¶ 10. Appeal 2019-005175 Reexamination Control 90/013,923 Patent 5,965,596 11 Declaration by Roger C. Harris, Ph.D. FF20. Dr. Harris stated: A single dose of beta-alanine would be unlikely to have any measurable effect on fatigue. It is not clear that a single dose would even be directed to the muscles and not some internal storage location in the body, such as the liver where beta- alanine is made and regulated. Harris Decl. ¶ 13. FF21. Dr. Harris explained: Muscle cells are bounded by membranes which control the uptake of metabolites and other compounds, according to the needs of the cells. Metabolites and other compounds, the concentration of which may temporarily be raised in plasma by the ingestion of food, do not passively cross in to the muscle cell but their uptake is regulated by transporters. This protects muscle cells from rapid fluctuations in concentrations of metabolites that could be detrimental, as well as from the loss to the exterior of the cell of metabolites as would be the case if transport was passively affected only by concentration gradients. Harris Decl. ¶ 14. FF22. Dr. Harris further explained: Dietary supplementation with most compounds or precursors has proved to be ineffective in raising the muscle level of these compounds and precursors in normally fed humans beyond that normally found. For example, it has recently been shown that the cofactor CoA content in muscle fails to be increased by supplementation with its precursor pantothenic acid. Harris Decl. ¶ 15. FF23. Dr. Harris further explained: Even if transported into a muscle cell, the retention of a metabolite and the ability of this to raise the intracellular Appeal 2019-005175 Reexamination Control 90/013,923 Patent 5,965,596 12 concentration still higher will be subject to feed-back mechanisms that prevent the metabolite exceeding (for reasons often unknown) an upper threshold level. Thus, the body typically maintains the concentration within a narrow concentration band (homeostasis). An example here is creatine, the level of which may be increased in some individuals with creatine supplements provided as described in paragraph 17 above, but only where the content is initially below about 160 mmol per kg dry muscle, and then only until the content reaches about 160 mmol per kg dry muscle. When the muscle content reaches about 160 mmol per kg dry muscle there is no further increase in the muscle content despite continued absorption into blood of dietary supplied creatine. Harris Decl. ¶ 18. FF24. Dr. Harris further explained: Prior to the studies upon which the [patent] . . . is based, scientific caution and rigor would have questioned: a) whether the mechanisms transporting beta-alanine into human muscle were already so saturated by the amount synthesized in the liver that further uptake into muscle was not possible, b) even if taken into muscle, the human's normal feed-back mechanisms would have precluded further increases in the synthesis of carnosine and the retention of this in muscle raising the muscle content, and c) whether any excess beta-alanine would have been deaminated and oxidised by metabolic routes understood at the time of Asatoor and Gardner. Harris Decl. ¶ 19. Appeal 2019-005175 Reexamination Control 90/013,923 Patent 5,965,596 13 Tallon10 FF25. Tallon discloses: Then in 2003, research presented at the American College of Sports Medicine on β-alanine in humans demonstrated that by consuming 800 mg four times a day for five weeks, a significant load or increase in muscle carnosine levels was achieved. Tallon 5 (unnumbered; for reference, we consecutively numbered from the first page of the document, beginning with 1). FF26. Tallon discloses: Research indicates that right around 3.2 grams of β-alanine supplementation, daily, can likely impart the desired benefits[]. However, this is only achieved after at least three to four weeks of continuous usage. Tallon 6. Balcombe11 FF27. Balcombe discloses: Researchers have shown that when supplementing with beta- alanine for just 4 weeks, we can increase our carnosine concentration by 42-65%. Longer beta-alanine studies going up to 10-12 weeks, show carnosine concentrations increased up to 80%. Due to the fact that beta-alanine continues to build carnosine concentrations AT LEAST up to 12 weeks, we recommend IntraXCell users to stay on IntraXCell continuously for a minimum of 12 weeks. Balcombe 12. 10 Tallon, M., “A New Science in Muscular Performance.” Exhibit 4 in Appeal Brief. Tallon is not prior art, but is a post-filing date publication. 11 Balcombe, S., “The Beta-Alanine Revolution,” 2010. Exhibit 3 of Appeal Brief. Tallon is not prior art, but is a post-filing date publication. Appeal 2019-005175 Reexamination Control 90/013,923 Patent 5,965,596 14 Discussion To establish inherent anticipation when a reference does not explicitly disclose a result which is recited in the claims, “the disclosure” must be “sufficient to show that the natural result flowing from the operation as taught would result in the performance” of the claimed result. In re Oelrich, 666 F.2d 578, 581 (CCPA 1981). The claimed result of administering beta-alanine is “whereby the concentration of beta-alanylhistidine is increased in the human tissue.” After reviewing Appellant’s rebuttal evidence, we are persuaded that evidence is sufficient to show that the increase of “beta-alanylhistidine dipeptide synthesis in the human tissue” and “the concentration of beta- alanylhistidine . . . in the human tissue” as required by all the rejected claims has not sufficiently been established to be a “natural result” of following Asatoor’s two-time administration at a two interval of beta-alanine (FF5). “Inherency . . . may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (internal quotation marks omitted). We begin with the discussion of the examples in the ’596 patent. In both Examples 1 and 4 of the patent, the beta-alanine was administered at multiple times during the day and over a period of days – 30 days in Example 1 (FF8, FF9) and 15 days in Example 4 (FF12, FF13). Only after a month of daily administration in Example 1 did carnosine levels increase in the muscle of the horses. FF10, FF11. In Example 4, the ’596 patent reported no change in the muscle carnosine content after daily Appeal 2019-005175 Reexamination Control 90/013,923 Patent 5,965,596 15 administration for two weeks (FF14, FF15), although Appellant later explained that three of six subjects actually showed an increase carnosine levels. As stated in the Decision in the related Reexamination of U.S. Patent 8,129,442 B2 (Appeal 2016-000745, Reexamination Control 95/002,048) (entered Feb. 27, 2017) (“the ’745 Dec.”): Co-inventor Roger C. Harris, Ph.D., provided a declaration (dated October 28, 2013) in which he attached the results of experiments, including the results of the experiments in Example 4 of the ’422 patent, which “show that the muscle carnosine content increased for three of the six subjects, but the muscle content for all six subjects tested averaged out to no increase. (Exhibit 1 at page 11).” 2013 Harris Decl. ¶ 4. Dr. Harris explained that the differences could be due to variation in responses observed in populations and inaccurate test methods. Id. at ¶¶ 3, 6. ’745 Dec. 9. Example 1 thus shows that daily administration of beta-alanine for 30 days achieved an increase in the muscle levels of carnosine. When a shorter duration of 14 days of beta-alanine administration to subjects was used, half of the time it was administered in Example 1, carnosine muscle levels did not increase in all subjects measured, and on average, there was no increase in carnosine muscle content. This evidence supports Patent Owner’s argument that one of ordinary skill in the art would have had reason to doubt that two dosages of beta- alanine, administered two-weeks apart as part of a tolerance study to determine plasma levels of the amino acid (FF5), necessarily would achieve the claimed increase in “beta-alanylhistidine dipeptide synthesis in the Appeal 2019-005175 Reexamination Control 90/013,923 Patent 5,965,596 16 human tissue” and increase in the tissue concentration of beta- alanylhistidine. Moreover, in view of the known decline in beta-alanine in blood serum after its administration as shown by Asatoor (FF6) and the ’596 patent (FF16), and the fact that even after 14 days of daily administration of beta- alanine not all subjects showed an increase in muscle beta-alanylhistidine content, one of ordinary skill in the art would not had a reasonable basis to believe that the two beta-alanine dosages, two weeks apart, as described in Asatoor, would necessarily and without “probabilities or possibilities” (Robertson, 169 F.3d at 745) achieve the claimed levels of beta- alanylhistidine. Consistently, Appellant provided articles by Tallon and Balcombe, published after the filing date, that four to five weeks of daily beta-alanine was found to increase muscle carnitine levels. FF25–FF27. The declarations by Dr. Hoffman and Dr. Harris cited in this reexamination provide additional evidence that one of ordinary skill in the art would have had reasonable doubt that Asatoor’s administration of beta- alanine necessarily, and as a natural result flowing from Asatoor (Oelrich, 666 F.29 at 581) meets the claimed tissue limitations. Dr. Hoffman testified in his declaration that before the “invention,” “no one knew how to cause any increase in beta-alanyl- L-histidine synthesis or to subsequently increase the amount of beta-alanyl-L- histidine retained in the muscle.” FF17, FF18. Both Dr. Hoffman and Dr. Harris testified that a one-time administration of a composition containing beta-alanine would not Appeal 2019-005175 Reexamination Control 90/013,923 Patent 5,965,596 17 have been expected to be directed to the muscle and lead to a measurable increase in beta-alanyl-L-histidine synthesis. FF19, FF20. Dr. Harris provided a scientific explanation as to why a single dosage would not have been expected to raise the carnosine levels. FF21–FF24. Specifically, Dr. Harris explained that muscle transport mechanisms (FF21), muscle feedback mechanisms regulating homeostasis of a particular compound (FF23), the metabolic degradation pathways of beta-alanine (FF24), and failure with other supplements (FF22, FF23) would have led one of ordinary skill in the art to doubt and disbelieve that carnosine levels could be necessarily increased by beta-alanine supplementation and that such increase in levels would be a natural result of carrying out Asatoor. Summary For the forgoing reasons, the rejection of claim 1, and dependent claims 2, 7, and 11, as anticipated by Asatoor is reversed. 2. REJECTION BASED ON ASATOOR AND BAUER The Examiner found that Bauer teaches that carnosine (beta-alanyl-L- histidine) is actively synthesized from beta-alanine in primary muscle cell cultures derived from chick embryonic muscle, and that teaching would have rendered obvious that the ingestion of beta-alanine taught by Asatoor would result in increased beta-alanyl-L-histidine. Ans. 6. We addressed a similar rejection in the ’745 Decision, reversing the obviousness rejection because the Examiner did not provide evidence that the chick muscle cell culture system described in Bauer would reasonably Appeal 2019-005175 Reexamination Control 90/013,923 Patent 5,965,596 18 predict the fate of beta-alanine in the body of a subject which is not a horse. ’745 Decision 26. The obviousness rejection of claims 1, 2, 7, and 11 is reversed for the same reasons because the chick muscle cell culture system in Bauer would not reasonably predict the fate of beta-alanine in human tissue either. 3–8. OBVIOUSNESS REJECTIONS BASED ON ASATOOR The Examiner cited the additional publications in rejections 3–8 to meet limitations in the dependent claims. Obviousness rejections 3–8 are reversed because the Examiner did not establish that the additional publications cited address the deficiencies found above in Asatoor or the combination of Asatoor and Bauer. Appeal 2019-005175 Reexamination Control 90/013,923 Patent 5,965,596 19 CONCLUSION In summary: Claims Rejected Basis Affirmed Reversed 1, 2, 7, 11 § 102 Asatoor 1, 2, 7, 11 1, 2, 7, 11 § 103 Asatoor, Bauer 1, 2, 7, 11 3–6 § 103 Asatoor, Birch, Balsom, Casey 3–6 3–6 § 103 Asatoor, Bauer, Birch, Balsom, Casey 3–6 8 § 103 Asatoor, Smith 8 8 § 103 Asatoor, Bauer, Smith 8 9, 10 § 103 Asatoor, Katsoyannis 9, 10 8–10 § 103 Asatoor, Bauer, Katsoyannis 8–10 Overall Outcome 1–11 REVERSED Appeal 2019-005175 Reexamination Control 90/013,923 Patent 5,965,596 20 For Patent Owner: Porzio, Bromberg & Newman P.C. 1200 New Hampshire Ave., NW Suite 710 Washington, DC 20036 For Third Party Requester: Hoffman & Baron, LLP 6900 Jericho Turnpike Syosset, NY 11791 Copy with citationCopy as parenthetical citation