Ex Parte Yamashita et alDownload PDFPatent Trial and Appeal BoardAug 30, 201612449909 (P.T.A.B. Aug. 30, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 12/449,909 12/04/2009 Makoto Yamashita 1933 7590 09/01/2016 HOLTZ, HOLTZ & VOLEK PC 630 Ninth A venue Suite 1010 NEW YORK, NY 10036-3744 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. 09370/RSB 4256 EXAMINER WANG, SHENGTIJN ART UNIT PAPER NUMBER 1627 NOTIFICATION DATE DELIVERY MODE 09/01/2016 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): USPTO@HHPATENT.COM pair_hhgc@cpaglobal.com rlevinsohn@hhpatent.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MAKOTO YAMASHITA and YOSHIHIRO KAW AOKA 1 Appeal2014-001859 Application 12/449,909 Technology Center 1600 Before DONALD E. ADAMS, FRANCISCO C. PRATS, and RICHARD J. SMITH, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims to a method for treating H5Nl influenza. The Examiner rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b ). We affirm. However, because our affirmance relies on somewhat different reasoning than the Examiner's, we designate our affirmance a new ground of rejection. 1 Appellants state that the "real party in interest is DAIICHI SANKYO COMP ANY, LIMITED." Br. 2. Appeal2014-001859 Application 12/449,909 STATEMENT OF THE CASE The sole rejection before us for review is the Examiner's rejection of claims 33 and 43 under 35 U.S.C. § 103(a) for obviousness over Honda 1 (U.S. Patent No. 6,340,702 Bl (issued Jan. 22, 2002)), Honda 2 (U.S. Patent Appl. Pub. No. 2002/0137791 Al (published Sept. 26, 2002)), and Russell (Rupert J. Russell et. al, The structure of H5Nl avian influenza neuraminidase suggests new opportunities for drug design, 443 Nature 45- 49 (2006)). Br. 2--4; Ans. 2---6. Claim 33 is representative and reads as follows (Br. 20): Claim 33. A method of treating H5Nl influenza, comprising administering to a person in need thereof a pharmacologically effective amount of 5-acetamido-4- guanidino-9-0-octanoyl-2,3,4,5-tetradeoxy-7-0-methyl-D- glycero-D-galacto-non-2-enopyranosoic acid. OBVIOUSNESS Appellants do not argue the rejected claims separately. We select claim 33 as representative of the rejected claims. 37 C.F.R. § 41.37(c)(iv). The Examiner cites Honda 1 as teaching "neuraminic acid derivatives having excellent sialidase (also called neuraminidase) inhibitory activity and being useful for treating or preventing (reducing the risk [ o ]f) influenza." Ans. 2. The Examiner finds in particular that Honda 1 describes the exact compound recited in the influenza treatment method of claim 33. Id. at 4, 6 (citing Example 3 5 and claim 50 of Honda 1 ). The Examiner notes that Honda 1 teaches that the compound GG-167 (zanamivir), also a sialidase inhibitor, was known in the art for treating influenza. Id. at 4. The Examiner cites Honda 2 as describing similar neuraminic acid derivatives for treating influenza. Id. at 4--5. 2 Appeal2014-001859 Application 12/449,909 The Examiner finds that the Honda references differ from claim 33 in that they do not teach "expressly the employment of the neuraminic acid derivatives herein for treating or preventing H5Nl influenza." Id. at 5. To address that deficiency, the Examiner cites Russell as evidence that sialidase inhibitors, including zanamivir, were known in the art to be useful for treating H5Nl influenza. Id. Based on the references' s teachings, the Examiner reasons that an ordinary artisan would have been motivated to use the Honda references' sialidase inhibitors to treat H5Nl influenza "because the neuraminic acid derivatives [t]herein are known for treating influenza generally and are structurally and functionally similar to zanamivir, which is particularly known for treating H5Nl influenza." Id. The Examiner finds that an ordinary artisan "would have reasonably expected that the neuraminic derivatives of Honda et al. [are] similar to, if not better than, zanamivir because the neuraminic derivatives are disclosed as excellent neuraminidase inhibitors." Id. As stated inin re Oetiker, 977F.2d1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden . . . of presenting a prima facie case of unpatentability .... After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. Appellants' arguments do not persuade us that a preponderance of the evidence fails to support the Examiner's prima facie case as to representative claim 33. Appellants do not contend that the Examiner erred in finding that Honda 1 describes the compound recited in claim 3 3, nor do Appellants 3 Appeal2014-001859 Application 12/449,909 contend that the Examiner otherwise mischaracterized the teachings of the cited references as compared to the limitations of claim 33. Rather, Appellants contend initially that an ordinary artisan would have found it arduous, onerous, and burdensome to carry out experiments to test the Honda 1 's compound to determine whether it was effective against the H5Nl virus, because a "highly-virulent" type of H5Nl virus, as opposed to an "attenuated-virulent" H5Nl (Br. 5), would have been required to perform such tests, and that type of the H5Nl virus is difficult to obtain, and requires laboratories that must fulfill many rigorous requirements. Id. at 5- 6. We are not persuaded. Appellants do not direct us to any clear or specific evidence supporting the assertion that an ordinary artisan would have considered a highly-virulent strain a requirement for testing for efficacy against H5Nl. Nor is a highly virulent strain recited in claim 33. Nor do Appellants identify any specific evidence suggesting that testing efficacy against the H5Nl virus required skill beyond that of an ordinary artisan. In particular, Appellants do not identify, in either the neuraminidase inhibition, cell culture, or mouse experiments described in the Specification (Spec. 15-18), or in the references cited below in support of the assertions of unexpected results, any disclosure supporting the assertion that testing the H5Nl virus required the skill beyond that of an ordinary artisan, or a highly- virulent strain. We also acknowledge, but are not persuaded by, Appellants' contentions (Br. 6-10), that the unpredictability in this art was such that an ordinary artisan would not reasonably have expected the compound of claim 33 to be capable of treating H5Nl in humans. 4 Appeal2014-001859 Application 12/449,909 Honda 1 discloses neuraminic acid derivatives having "excellent sialidase inhibitory activity, which is significantly greater than that of the prior art compounds referred to above [including GG-167 (zanamivir)], and which can thus be used for the treatment and prevention of influenza and other diseases caused by sialidase-bearing viruses." Honda 1, 2: 19--23. 2 As one of its sialidase-inhibiting compounds, Honda 1 undisputedly exemplifies and claims the compound recited in Appellants' claim 3 3. Id. at 165: 3 6- 166 :45 (Example 35), 253:1-8 (claim 50) (both cited by Examiner). Honda 1, thus, provides a reason for using the compound recited in Appellants' claim 33 to treat patients with influenza caused by sialidase-bearing viruses. While it might be true that Honda 1 does not describe treating H5Nl influenza with the claimed compound, as the Examiner points out, Russell discloses that H5Nl is a sialidase-bearing virus that causes influenza. See Russell, abstract (describing H5Nl as an influenza-causing virus that bears a neuraminidase (i.e., sialidase) enzyme). As the Examiner points out, zanamivir/Relenza, which targets the neuraminidase enzyme, was being used to treat H5Nl influenza. Id. Given Russell's teachings that sialidase inhibitors such as zanamivir/Relenza were useful for treating H5Nl influenza, and given Honda 1 's disclosure that its compounds, which include the compound recited in claim 3 3, were useful for treating influenza caused by sialidase- bearing viruses, and possessed sialidase-inhibiting properties superior to zanamivir/Relenza, we agree with the Examiner that an ordinary artisan had 2 Appellants do not dispute the Examiner's assertion that GG-167 is zanamivir, which is also referred to in Appellants' Brief as "RELENZA." Br. 10. 5 Appeal2014-001859 Application 12/449,909 sufficient reason for, and a reasonable expectation of success in, treating H5Nl influenza using the compound recited in claim 33. Because Honda 1 undisputedly exemplifies the claimed compound, we are not persuaded (Br. 7) that an ordinary artisan would have had to experiment unduly to find a compound suitable for treating H5Nl influenza. Given Russell's express teaching that zanamivir/Relenza was being used to treat H5Nl, the lack of experimental data in Russell as to zanamivir/Relenza against H5Nl (Br. 7) does not persuade us that an ordinary artisan would have failed to recognize from Russell that sialidase inhibitors were known to be useful in treating influenza caused by sialidase- bearing viruses. Appellants advance no specific persuasive evidence undermining Russell's teaching in that regard. Similarly, the absence of experimental data as to the compound of claim 33 in Honda 1 and Russell (id. at 7-8) does not persuade us that an ordinary artisan lacked a reasonable expectation of success, given the teachings in Honda 1 and Russell, discussed above, strongly suggesting that the compound recited in claim 33 would be useful against H5Nl. Nor does the fact that different subtypes of influenza viruses were known to have different susceptibilities to different drugs (Br. 8-10 (citing Yamashita, Table 3))3 persuade us that an ordinary artisan lacked impetus or a reasonable expectation of success in treating H5Nl influenza with the compound recited in Appellants' claim 33, given the references' teachings discussed above. 3 Makoto Yamashita, Laninamivir and its prodrug, CS-8958: long-acting neuraminidase inhibitors for the treatment of influenza, 21 Antiviral Chemistry & Chemotherapy 17-84 (2010). 6 Appeal2014-001859 Application 12/449,909 To the contrary, it is well-settled that "[o]bviousness does not require absolute predictability of success .... For obviousness under§ 103, all that is required is a reasonable expectation of success." In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) (quoting In re O'Farrell, 853 F.2d 894, 903---04 (Fed. Cir. 1988) (emphasis removed). Faced with a factual situation similar to that at issue herein, in 0 'Farrell the court found that a reasonable expectation of success had been established, despite the fact that the cited prior art only speculated at success, and, as here, did not provide conclusive experimental proof that the suggested process would work as described in the art. O'Farrell, 853 F.2d at 900-901. Thus, that the prior art might not have provided definitive experimental proof that the compound of claim 33 would be effective against H5Nl, or that the art recognized a degree of uncertainty as to which sialidase inhibitors might work against which viral subtypes, does not persuade us that an ordinary artisan lacked a reasonable expectation of success, given that sialidase inhibitors were known in the art generally to be useful for treating H5Nl influenza. We acknowledge, but are not persuaded by, Appellants' contentions that the compound recited in claim 3 3 possesses "unexpectedly superior results" (Br. 13), as compared to zanamivir/Relenza and oseltamivir/Tamiflu (see id. at 10-19). In particular, Appellants contend that the Kiso reference4 shows that the compound of claim 33 ("CS-8958") reduced virus titer in the lungs of mice infected with H5Nl virus (A/Hanoi/30408 strain, also termed "HN30408cl 7") to a greater degree, and at a lower dosage, than 4 Maki Kiso et al., Efficacy of the New Neuraminidase Inhibitor CS-8958 against HSNJ Influenza Viruses, 6 PLoS Pathogens 1-10 (2010) 7 Appeal2014-001859 Application 12/449,909 oseltamivir/Tamitlu, and also to a greater degree than zanamivir/Tamitlu, which was tested in the Le reference 5 in ferrets infected with the same strain ofH5Nl. Br. 12-16 (citing Kiso 5 (Table 2); Le 1108 (Fig. lb)). Appellants also direct us to data from the Specification showing that more H5Nl-infected mice survived longer, on significantly lower dosages of the compound of claim 33, as compared to oseltamivir phosphate. Br. 17-19 (citing Spec. 17-18 (Table 3)). It is well settled, however, that "any superior property must be unexpected to be considered as evidence of non-obviousness." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). In the instant case, as noted above and noted by the Examiner (Ans. 6), Honda 1 expressly teaches that its compounds, which include the compound used in the method of claim 33, are more potent sialidase inhibitors than previously known sialidase inhibitors, including zanamivir. Honda 1, 2: 19-23. Moreover, the sole assertion that the results advanced by Appellants show an unexpected improvement is the assertion by Appellants' counsel. Argument by counsel in that regard is not an adequate substitute for actual evidence, however. See In re Geisler, 116 F.3d 1465, 1471 (Fed. Cir. 1997). To that end, we note that, rather than stating that unexpectedly superior results were predicted in humans, Kiso merely states that the compound of claim 33 is "a promising candidate for a new neuraminidase inhibitor to prevent and treat influenza patients infected with H5Nl and other subtype viruses." Kiso 8. 5 Q. Mai Le et al., Isolation of drug-resistant HSNJ virus, 437 Nature 1108 (2005). 8 Appeal2014-001859 Application 12/449,909 It is also well settled that a showing of unexpectedness must be commensurate in scope with the claimed subject matter. See In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) ("[A]pplicant's showing of unexpected results must be commensurate in scope with the claimed range."). In the instant case, claim 33 is limited to treating humans. See Br. 20 ("administering to a person") (claim 33). In contrast, all of the evidence advanced by Appellants to show unexpected superiority describes experiments in mice (Kiso; Spec. 17-18 (Table 3)) or ferrets (Le). Appellants do not advance specific persuasive evidence suggesting that an ordinary artisan would have understood that a showing of unexpected superiority in those animals demonstrates a showing of unexpected superiority in the human patients recited in claim 33. To the contrary, as noted above, rather than suggesting that its results would be comparable in humans, Kiso states only that claim 33 's compound is "a promising candidate" in influenza treatments (Kiso 8), thus suggesting that an ordinary artisan would have recognized that testing in humans would be required to confirm the animal results. It is well settled, moreover, that "when unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art." In re Baxter-Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). In the instant case, while Appellants assert that zanamivir is the closest prior art compound (Br. 10-11 ), it is undisputed that the compound recited in claim 3 3 was known in the prior art, indeed exemplified and claimed by Honda 1 (165:36-166:45 (Example 35), 253: 1- 8 (claim 50)), and was described by Honda 1 a sialidase inhibitor useful 9 Appeal2014-001859 Application 12/449,909 against influenza viruses (see, e.g. id. at abstract). Accordingly, we are not persuaded that Appellants' comparisons include the closest prior art compound. In sum, for the reasons discussed, Appellants' arguments do not persuade us that a preponderance of the evidence fails to support the Examiner's prima facie case of obviousness as to representative claim 33. Because, for the reasons discussed, we do not find that Appellants' evidence and arguments regarding unexpected results outweigh the Examiner's showing of prima facie obviousness, we affirm the Examiner's rejection of claim 33 under 35 U.S.C. § 103(a). Because it was not argued separately, claim 43 falls with claim 33. 37 C.F.R. § 41.37(c)(iv). The Examiner, however, did not clearly address the full scope of Appellants' contentions and evidence regarding unexpected results. See Ans. 6-7. Thus, in affirming the rejection of claim 33, based on the discussion above, our analysis differs somewhat from the Examiner's. We, therefore, designate our affirmance a new ground of rejection under 37 C.F.R. § 41.50(b). SUMMARY For the reasons discussed, we affirm the Examiner's rejection of claims 33 and 43 under 35 U.S.C. § 103(a) for obviousness over Honda 1, Honda 2, and Russell. Because our rationale for affirming the rejection differs somewhat from the Examiner's, we designate our affirmances a new grounds of rejection under 37 C.F.R. § 41.50(b). 10 Appeal2014-001859 Application 12/449,909 TIME PERIOD FOR RESPONSE This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960 (August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37 C.F.R. § 41.50(b) provides "[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review. 37 C.F.R. § 41.50(b) also provides that the appellant, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the proceeding will be remanded to the examiner .... (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same record .... AFFIRMED, 37 C.F.R. § 41.50(b) 11 Copy with citationCopy as parenthetical citation