Ex Parte Kidane et al

Patent Trial and Appeal BoardNov 13, 2018

13638294 (P.T.A.B. Nov. 13, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/638,294 09/28/2012 Argaw Kidane 90368 7590 11/15/2018 Foley & Lardner LLP 3000 K STREET N.W. SUITE 600 WASHINGTON DC, DC 20007-5109 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. 063089-1302 7787 EXAMINER GOTFREDSON,GAREN ART UNIT PAPER NUMBER 1619 NOTIFICATION DATE DELIVERY MODE 11/15/2018 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): ipdocketing@foley.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ARGAW KIDANE and PADMANABH P. BHATT 1 Appeal2017-005149 Application 13/638,294 Technology Center 1600 Before DONALD E. ADAMS, ERIC B. GRIMES, and RYAN H. FLAX, Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL This is a decision under 35 U.S.C. Â§ 134(a) involving claims directed to a solid modified release formulation of mazindol. Claims 47-67 and 69- 72 are on appeal as rejected under 35 U.S.C. Â§ 112, second paragraph, and Â§ 103, as well as for obviousness-type double patenting. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We affirm. 1 Appellants identify the Real Party in Interest as "Supemus Pharmaceuticals, Inc." Appeal Br. 3. Herein we reference the Specification of Sept. 28, 2012 ("Spec."); Final Office Action of Feb. 12, 2016 ("Final Action"); Appeal Brief of Aug. 10, 2016 ("Appeal Br."); Examiner's Answer of Dec. 16, 2016 ("Answer"); and Reply Brief of Feb. 14, 2017 ("Reply Br."). Oral argument was heard on November 1, 2018; the transcript of the hearing will be made a part of the record on appeal. Appeal2017-005149 Application 13/638,294 STATEMENT OF THE CASE Independent claim 47 is representative and is reproduced below: 4 7. A solid modified release formulation of mazindol comprising mazindol as an active pharmaceutical ingredient, at least one release controlling polymer selected from pH- dependent polymers and pH-independent polymers, and at least one pharmaceutically acceptable excipient, wherein the total amount of water in the formulation is not more than 2% by weight of the formulation. Appeal Br. 11 (Claims Appendix). The following rejections are considered on appeal: Claims 48 and 51-58 stand rejected under 35 U.S.C. Â§ 112, second paragraph, as indefinite. 2 Final Action 3. Claims 47-57, 61---67, 69, 70, and 72 stand rejected under 35 U.S.C. Â§ I03(a) over Devane, 3 Konofal, 4 Maulding, 5 and Enose. 6 Id. at 5. Claims 58-60 stand rejected under 35 U.S.C. Â§ I03(a) over Devane, Konofal, Maulding, Enose, and Swanson. 7 Id. at 8-9. Claim 71 stands rejected under 35 U.S.C. Â§ I03(a) over Devane, Konofal, Maulding, Enose, and Hirsh. 8 Id. at 9-10. 2 We note, the Examiner's statement of rejection indicates "[c]laims 48, 51, and 52-57" stand rejected as indefinite; however, claim 58 is substantively discussed as rejected as indefinite and, so, we understand it to be included in the rejection. Final Action 3--4. 3 US 2006/0240105 Al (published Oct. 26, 2006) ("Devane"). 4 US 2009/0136593 Al (published May 28, 2009) ("Konofal"). 5 H.V. Maulding et al., Solvolysis of a Substituted Imidazoline, Mazindol, 64(11) J. PHARMA. SCI. 1833-38 (1975) ("Maulding"). 6 US 2009/0042821 Al (published Feb. 12, 2009) ("Enose"). 7 US 2008/0124393 Al (published May 29, 2008) ("Swanson"). 8 US 2006/0024366 Al (published Feb. 2, 2006) ("Hirsh"). 2 Appeal2017-005149 Application 13/638,294 Claims 47-67, 69-71, and 90 stand rejected for obviousness-type double patenting over U.S. Patent Application 13/841,898 and Devane and Hirsh. Id. at 14. 9 DISCUSSION "[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting aprimafacie case ofunpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). We have considered Appellants' arguments made in the Appeal Brief and properly presented in the Reply Brief; arguments not so-presented in the Briefs are waived. See 37 C.F.R. Â§ 4I.37(c)(l)(iv) (2015); see also Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative) ("Any bases for asserting error, whether factual or legal, that are not raised in the principal brief are waived."). I. INDEFINITENESS For claims under examination, "'a claim is indefinite when it contains words or phrases whose meaning is unclear,"' i.e., "ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention." In re Packard, 751 F.3d 1307, 1310-13 (Fed. Cir. 2014); see also MPEP Â§ 2173.02(I) (Rev. 07.2015, Nov. 2015) (advising examiners that a rejection for indefiniteness is appropriate "after applying the broadest reasonable interpretation to the claim, if the metes and bounds of the claimed invention are not clear"). As explained in the MPEP 9 U.S. Patent Application 13/841,898 was abandoned August 7, 2015. See Notice mailed March 3, 2016. Therefore, this rejection is dismissed. 3 Appeal2017-005149 Application 13/638,294 Â§ 2173.05(e), a "lack of clarity could arise [for example] where a claim refers to 'said lever' or 'the lever,' where the claim contains no earlier recitation or limitation of a lever and where it would be unclear as to what element the limitation was making reference." As noted by the Examiner, Appellants' briefing does not address this rejection. See generally Appeal Brief; see also Answer 6. "When the appellant fails to contest a ground of rejection to the Board, ... the Board may treat any argument with respect to that ground of rejection as waived. In the event of such a waiver, the PTO may affirm the rejection of the group of claims that the examiner rejected on that ground without considering the merits of those rejections." Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008). Therefore, we affirm this rejection. IL OBVIOUSNESS "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007). "In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid underÂ§ 103." Id. at 419. Findings of Fact ("FF'') Except as otherwise indicated below, we adopt the Examiner's findings of fact and rationale as set forth in the Final Action and Answer. The following findings of fact highlight certain evidence relevant to the issue of obviousness. 4 Appeal2017-005149 Application 13/638,294 FF 1. Devane discloses pharmaceutical formulations that are immediate release, delayed release, or controlled or extended release, or combinations of these types of release profiles. Devane ,r,r 26-30. FF2. Further to the preceding finding of fact, Devane discloses that the active ingredient for such pharmaceutical formulations can be the anorectic drug mazindol at a dosage of from about 0.1 to about 1,000 mg. Devane ,r,r 59, 64. FF3. Further to the preceding findings of fact, Devane discloses that the pharmaceutical formulation can be a solid, multilayered tablet, including an excipient, and that its modified release profile can be achieved via coating materials including a selection of pH dependent and pH independent polymers. 10 Devane ,r,r 71-74. FF4. Further to the preceding finding of fact, Devane does not disclose the water content of such a tablet. See generally Devane. FF5. Konofal discloses the therapeutic use of mazindol to treat attention deficit/hyperactivity disorder and discloses formulating the mazindol as tablets and powders, including prolonged and delayed release formulations, and including excipients. Konofal Abstract, ,r,r 1, 43, 69. FF6. Konofal does not specify the water content of its tablet and/or powder formulations; however, a powder is understood to be a 1Â° Cf Appellants' claim 63 (pH-dependent polymers include hydroxypropyl methylcellulose acetate succinate and shellac) and claim 64 (pH-independent polymers include carboxymethylcellulose and celluose acetate). 5 Appeal2017-005149 Application 13/638,294 fine, dry particulate formulation of a solid substance. See Oxford Dictionary, powder, https://en.oxforddictionaries.com/definition/ - powder, Nov. 5, 2018. FF7. Enose discloses a pharmaceutical formulation, for example, a tablet or coated tablet or powder, where the water content is 6.5% or less, which range would include 2% and even none at all. Enose Abstract, ,r,r 31-33. FF8. Further to the preceding finding of fact, Enose discloses producing such a formulation by using excipients having low water content and manufactured using dry or non-aqueous formulation processes. Enose ,r 34. FF9. The Specification describes optimizing the stability of mazindol in a formulation by preferably compressing "a dry powder blend." Spec. ,r 66; compare supra FF5. FFlO. The Specification does not provide evidence that mazindol formulations having no more than 2% water content are more stable than any other specific water content formulations. See Spec. ,r 107 (Example 14), Figure 12; cf Kidane Declaration ,r 13 (stating "[d]uring the same period, conventionally prepared mazindol formulations having greater water content (i.e., between 3 and 5%) fared far worse (about 17% hydrolysis)," citing what is stated to be "Figure 12 of the application (reproduced below).") 11 . 11 Argaw Kidane Declaration Under 37 C.F.R. Â§ 1.132, dated Aug. 26, 2015 ("Kidane Declaration"). As discussed below, the Kidane Declaration does not reproduce the Specification's Figure 12, as it indicates. 6 Appeal2017-005149 Application 13/638,294 Analysis The Examiner determined claims 47-57, 61---67, 69-70, and 72 would have been obvious over the combination of Devane, Konofal, Maulding, and Enose, and that claims 58---60 would have been obvious over this same prior art combination also adding Swanson, and further that claim 71 would have been obvious over this same combination also adding Hirsh. See generally Final Action and Answer. Appellants argue all claims together. Therefore, we address the claims and their rejections similarly. We have concluded claim 47 is representative and all claims fall therewith. Appellants argue that no cited prior art provides a rationale (motivation) for formulating mazindol in a solid dosage form having no more than 2% water, as claimed. Appeal Br. 4. Appellants do not dispute "that minimizing or eliminating water from a solid formulation of a drug known to hydrolyze in 'solid'form was a solution known in the art." Id. However, Appellants argue that the Examiner makes too great a leap in assuming that the hydrolysis of mazindol in an aqueous solution, as disclosed in Maulding, would have motivated the skilled artisan to reduce the water content of solid formulations of mazindol to 2% or less. Id. Appellants argue Maulding's disclosure of the hydrolysis of mazindol in aqueous solution would not extend to solid formulations. Id. at 5. While Appellants' contention that Maulding would not have necessarily motivated the skilled artisan to reduce the water content of a mazindol solid formulation is reasonable, the evidence on appeal does not support that any reduction in water content of prior art solid mazindol 7 Appeal2017-005149 Application 13/638,294 formulations would have been required. As noted in the findings of fact above, the prior art combination taught and suggested a solid formulation of mazindol as claimed, a polymer as claimed, and an excipient as claimed. FF1-FF4. Further, the prior art combination also taught and suggested that a solid formulation of mazindol would be a dry formulation. FF5-FF6. Moreover, the prior art combination also taught and suggested that forming such low-water-content, solid formulations was well within the ability of the skilled artisan. FF7-FF8. There is no persuasive evidence on this appeal record that prior art mazindol formulations would have more than 2% water content. FF9-FF10. The cited prior art suggests they would not. "Where ... the claimed and prior art products are identical or substantially identical ... 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. ... [The] fairness [of the burden-shifting] is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products." In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Here, the prior art combination teaches and suggests a solid mazindol formulation that is at least substantially identical to the claimed solid modified release mazindol formulation. Appellants have not shown that the prior art formulations are different from the claimed formulation. Appellants have submitted the Kidane Declaration as support for the contentions that Maulding would not have motivated the skilled artisan to lower a mazindol formulation water content and that Appellants have shown unexpected results, where greater mazindol stability is achieved with a 2% water content formulation as compared to a higher water content 8 z,' ! Appeal2017-005149 Application 13/638,294 formulation. While we may agree with the former contention, as discussed above, we cannot conclude that the latter is supported by evidence. The Kidane Declaration includes a paragraph (13) concluding that a mere 1-3% water-content reduction to 2% or less resulted in unexpected improvements in mazindol stability. As evidence, the Kidane Declaration purports to reproduce Figure 12 from the Specification; however, it is apparent that the declaration has not faithfully done so because the figure produced therein is different from the Specification's Figure 12. 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