Ex Parte Lum et alDownload PDFPatent Trial and Appeal BoardJan 27, 201713075116 (P.T.A.B. Jan. 27, 2017) 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. 13/075,116 03/29/2011 Robert T. Lum 056274-4451 1066 90135 7590 Telik, Inc. c/o Foley & Lardner LLP 3000 K STREET N.W. SUITE 600 WASHINGTON, DC 20007-5109 EXAMINER KASSA, JESSICA M ART UNIT PAPER NUMBER 1616 NOTIFICATION DATE DELIVERY MODE 01/31/2017 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): ipdocketing @ foley. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ROBERT T. LUM, STEPHAN D. PARENT, CHUNSHENG QIAO, and STEVEN R. SCHOW Appeal 2014-009870 Application 13/075,116 Technology Center 1600 Before ERIC B. GRIMES, KIMBERLY McGRAW and RYAN H. FLAX, Administrative Patent Judges. McGRAW, Administrative Patent Judge. DECISION ON APPEAL Appellants appeal under 35 U.S.C. § 134(a) from a final rejection of claims 1 and 3—23. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal 2014-009870 Application 13/075,116 STATEMENT OF THE CASE Appellants’ invention is directed to a pharmaceutically acceptable tablet comprising ezatiostat hydrochloride, a compound that can be used for treatment of myelodysplastic syndrome. Spec. ]Hf 2, 5. Claims 1 and 23 are the only independent claims on appeal and are reproduced below: 1. A pharmaceutically acceptable tablet comprising ezatiostat hydrochloride, an intragranular excipient, and an extragranular excipient, wherein the ezatiostat hydrochloride comprises from about 75 to about 82 percent by weight of the tablet. 23. A pharmaceutically acceptable tablet comprising ezatiostat hydrochloride, an intragranular excipient, and an extragranular excipient, wherein the ezatiostat hydrochloride comprises from about 75 to about 82 percent by weight of the tablet, wherein the intragranular excipient is selected from the group consisting of mannitol, croscarmellose sodium, and hypromellose, or a mixture thereof, and extragranular excipient is croscarmellose sodium and/or magnesium stearate. App. Br. 16, 18—19 (Claims App’x). REJECTIONS Claims 1 and 3—23 stand rejected under 35 U.S.C. § 103(a) over Azra Raza et al., Phase 1 multicenter dose-escalation study of ezatiostat hydrochloride (TLK199 tablets), a novel glutathione analog prodrug, in patients with myelodysplastic syndrome, 113 Blood 6533 (2009), Kauvar (US 5,955,432, issued Sept. 21, 1999), Tawa (US 7,790,905 B2, issued Sept. 7, 2010), H. Hey et al., Oesophageal transit of six commonly used tablets 2 Appeal 2014-009870 Application 13/075,116 and capsules, 285 British Medical Journal 1717 (1982), Sprockel et al. (US 2004/0175419 Al, published Sept. 9, 2004) and Jackisch et al. (US 5,114,003, issued May 19, 1992). Final Act. 3. ANALYSIS We have reviewed the rejections of the pending claims in light of Appellants’ arguments contending that the Examiner erred. In doing so, we have evaluated only the arguments that Appellants actually make on appeal. Arguments that Appellants could have made, but declined to make, are considered waived. See 37 C.F.R. § 41.37(c)(l)(iv). Claim 1 Appellants argue the asserted references, alone or in combination, do not teach or suggest a pharmaceutically acceptable tablet comprising about 75 to about 82 weight percent of ezatiostat hydrochloride as recited in claim 1. Appellants also argue that one skilled in the art would not have had a reasonable expectation of successfully preparing a pharmaceutically acceptable tablet having such a high concentration of ezatiostat hydrochloride and that preparation of a formulation comprising the claimed percentage of ezatiostat hydrochloride is surprising and unexpected. Id. at 7, 13. These arguments are not persuasive. The Examiner finds Raza teaches the oral administration of a pharmaceutically acceptable tablet (TLK199) that has the same amount of ezatiostat hydrochloride (100 mg and 500 mg) as well as the same excipients recited in Appellants’ claimed invention. See, e.g., Advisory Act. 2; Final Act. 3, 8—9, 12—13 (citing Razap. 6535); see also Spec. 12, 50. The Examiner concedes that Raza does not explicitly disclose the 3 Appeal 2014-009870 Application 13/075,116 weight percentage of ezatiostat hydrochloride in the tablet. However, the Examiner finds that because the tablet of Raza comprises the same ezatiostat hydrochloride and the same excipients recited in the claims, it is reasonable to conclude that Raza has similar amounts of ezatiostat hydrochloride. See, e.g., Advisory Act. 2; see also Final Act. 4, 8—9 (stating because the active ingredient and the excipients of Raza are the same as found in the instantly claimed invention, the tablets of Raza are expected to have similar percentages of ezatiostat hydrochloride). The Examiner further finds that routine optimization of percentages of the components of a pharmaceutical composition/tablet and dosage amounts is within the purview of one of ordinary skill in the art in the absence of surprising and unexpected results and that the Appellants have not provided sufficient evidence of unexpected results. Id. at 10—11. Additionally, the Examiner finds that it would have been obvious to one of ordinary skill in the art to minimize the amounts of excipients and maximize the percentage of active in view of Hey’s teaching that smaller tablets are more easily swallowed. Id. at 9. The Examiner also finds that one of ordinary skill in the art would have had a reasonable expectation of success because the tablets of Raza already contain the same active and excipients as in the instantly claimed invention. Id. The Examiner further finds that Appellants have not provided any evidence illustrating any significant difficulty in preparing pharmaceutically acceptable tablets having the amounts of active ingredient or excipients recited in the claims. Id. We agree with the Examiner’s findings and conclusions. Differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such 4 Appeal 2014-009870 Application 13/075,116 concentration is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also In re Hoeschele, 406 F.2d 1403, 1406 (CCPA 1969) (stating claims are unpatentable because, inter alia, there was no evidence of the criticality of the claimed ranges of molecular weight or proportion). Appellants do not provide persuasive evidence or argument to show that the claimed weight percentage of ezatiostat hydrochloride is critical or that it would not have been obvious to prepare a tablet having ezatiostat hydrochloride at the claimed concentrations. See, e.g., App. Br. 13—14. Appellants rely upon the declaration of Michael Mitchell, Ph.D. (App. Br. Appendix B, “Mitchell Decl.”), which states that “the ability to obtain a [pharmaceutically acceptable] tablet with a high load of active as in the claimed invention is unpredictable” and opines that the likelihood of success in predicting the pharmaceutical suitability of the claimed formulation would be no more than about 20%. App. Br. 13—16; Mitchell Decl. ^fl[ 7, 8. Dr. Mitchell’s declaration does not persuasively rebut the evidence relied on by the Examiner as it does not address the likelihood of success of predicting the pharmaceutical suitability of the claimed formulation in view of the teachings of the closest prior art, Raza. Notably, the declaration fails to even mention Raza, fails to address the prior art’s teaching of the 5 Appeal 2014-009870 Application 13/075,116 therapeutic administration of a tablet containing the same active ingredient, ezatiostat hydrochloride, and the same excipients as recited in Appellants’ claim, and fails to provide any persuasive explanation as to why Appellants’ claimed tablet would have been unexpected in view of Raza. As such, Appellants’ evidence and arguments are not sufficient to overcome the Examiner’s prima facie case of obviousness. Appellants also contend the rejection requires five different references and that this is evidence that the appealed claims are non-obvious. App. Br. 7. This argument is also not persuasive as reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See, e.g., In re Gorman, 933 F.2d 982 (Fed. Cir. 1991) (affirming a rejection of a detailed claim to a thumb-shaped candy on a stick based on thirteen prior art references). For the foregoing reasons, the Examiner’s rejection of claim 1 is sustained. Claims 3—23 Appellants argue claims 3—23 are not obvious for the same reason presented for claim 1. App. Br. 14. As we affirmed the Examiner’s rejection of claim 1, this argument is not persuasive. Appellants also state the references do not teach or suggested the “ranges of excipients recited in claims 6—11 and 13—16 in combination with the very high level of ezatiostat hydrochloride as per the claimed invention.” Id. Appellants’ contentions are little more than a summary of certain claim features and a general assertion that the prior art does not teach or suggest those features. See 37 C.F.R. § 41.37(c)(l)(iv) (“A statement which merely points out what a claim recites will not be considered an argument for 6 Appeal 2014-009870 Application 13/075,116 separate patentability of the claim.”); see also In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) (“[W]e hold that the Board reasonably interpreted Rule 41.37 to require more substantive arguments in an appeal brief than a mere recitation of the claim elements and a naked assertion that the corresponding elements were not found in the prior art.”). The Examiner made specific findings regarding the excipients and ranges recited in claims 6—11 and 13—16 and explained why the claims are unpatentable over the prior art, which we find to be reasonable and to present prima facie cases of unpatentability. See, e.g., Final Act. 6 (finding Tawa’s disclosure of 0.2—5 wt% croscarmellose meets claim 13 ’s limitation requiring croscarmellose in an amount “from about 1.5 to about 3.5 percent by weight of the tablet”); see also Advisory Act. 2; Final Act. 4—11; Ans. 4— 5. Appellants have not provided any particularized evidence or argument to show that the Examiner’s findings or conclusions are in error. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992) (stating once the Examiner has established an initial case of unpatentability, Appellants have the burden of coming forward with evidence or arguments demonstrating error in the Examiner’s rejection); cf. In re Baxter Travenol Labs., 952 F.2d 388, 391 (Fed. Cir. 1991) (“It is not the function of this court to examine the claims in greater detail than argued by an appellant, looking for [patentable] distinctions over the prior art.”); In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (stating mere lawyer’s arguments and conclusory statements that are unsupported by factual evidence are entitled to little probative value). As such, Appellants have not persuaded us that the Examiner erred in rejecting claims 6—11 and 13—16. 7 Appeal 2014-009870 Application 13/075,116 For the foregoing reasons, we sustain the Examiner’s rejections of claims 3—23. DECISION The Examiner’s rejection of claims 1 and 3—23 are affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED 8 Copy with citationCopy as parenthetical citation