XW LABORATORIES INC.Download PDFPatent Trials and Appeals BoardOct 25, 20212021004210 (P.T.A.B. Oct. 25, 2021) 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. 16/988,200 08/07/2020 JIA-NING XIANG 65YC-000250US-320157 4404 132724 7590 10/25/2021 Sheppard Mullin Richter & Hampton LLP 650 Town Center Drive, 10th Floor Costa Mesa, CA 92626 EXAMINER AULAKH, CHARANJIT ART UNIT PAPER NUMBER 1625 NOTIFICATION DATE DELIVERY MODE 10/25/2021 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): SVPatents@sheppardmullin.com SheppardMullin_Pair@firsttofile.com wlambert@sheppardmullin.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JIA-NING XIANG, XUESONG XU, and XUAN ZHANG Appeal 2021-004210 Application 16/988,200 Technology Center 1600 Before DONALD E. ADAMS, TAWEN CHANG and RYAN H. FLAX, Administrative Patent Judges. CHANG, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claim 1.2 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as XW Laboratories Inc. Appeal Br. 3. 2 The Examiner also rejected claims 1–20 on the ground of non-statutory obviousness-type double patenting over claims 1–5, 8, 9, 13–15, and 18–30 of U.S. Patent 10,501,401, claims 1–5, 8–11, and 13–30 of U.S. Patent Appeal 2021-004210 Application 16/988,200 2 STATEMENT OF THE CASE “Narcolepsy is a chronic neurological disorder characterized by excessive daytime sleepiness (EDS), cataplexy, sleep paralysis, hypnagogic hallucinations, and disturbed nocturnal sleep.” Spec. ¶ 2. Gamma- hydroxybutyric acid (GHB) is “a naturally-occurring central nervous system (CNS) transmitter,” and “[t]he GHB sodium salt also called sodium oxybate . . . is approved by the U.S. Food and Drug Administration (FDA) to treat cataplexy associated with narcolepsy” as well as EDS. Id. ¶ 3. According to the Specification, “[d]espite its efficacious effect and advantageous position in treating EDS and cataplexy associated with narcolepsy, sodium oxybate displays a sub-optimal pharmacokinetics profile that makes it difficult to provide optimal therapeutic benefits,” and “there remains a continuing need for compounds derived from GHB to overcome some or all of [sodium oxybate’s] deficiencies.” Id. ¶ 4. Further according to the Specification, the invention “generally relates to prodrugs of . . . GHB[], as well as compositions and uses thereof.” Spec. ¶ 1. 10,640,451, and claims 1–4, 6, 8–10, 13–23, 26, and 27 of U.S. Patent 10,774,031. Ans. 3. Appellant filed a terminal disclaimer with respect to the ’410 patent, the ’451 patent, and the ’031 patent on June 21, 2021. Appeal Br. 3. The administrative record reflects that the Office approved the terminal disclaimer. See Electronic Terminal Disclaimer – Approved, entered into this record June 21, 2021. Thus, we understand these rejections to be moot. To the extent the rejections are not moot, they would be summarily affirmed. Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008) (holding that the PTO may affirm a rejection without considering the merits of the rejection where “appellant fails to contest a ground of rejection to the Board”). Appeal 2021-004210 Application 16/988,200 3 Claim 1, the only claim on appeal, is reproduced below: 1. The compound (S)-4-(2-amino-3 methybutanoyloxy)butanoic acid: or a pharmaceutically acceptable salt thereof. Appeal Br. 9 (Claims App.). Claim 1 is rejected under 35 U.S.C. § 102(a)(1) over Johansson.3 OPINION It is not disputed that Johansson literally recites 4-(L-valyloxy)butyric acid as a reactant in step (b) of its Example 7, or that 4-(L-valyloxy)butyric acid is the compound recited in claim 1. Final Act. 2; see also Johansson 122:20–25, 123:7–18. However, Appellant contends that “[t]he disclosure of the compound 4-(L-valyoxy)butyric acid in Johansson is a typographical error” such that Johansson cannot be said to have disclosed the compound to those skilled in the art. Appeal Br. 4–7. In particular, Appellant contends that a skilled synthetic chemist would recognize that the correct reactant in step (b) of Johansson’s Example 7 should be “the tert-butyloxycarbonyl (Boc) protected compound, 4-(N- Boc-L-valyloxy)butyric acid,” because (1) the reaction described in step (b) of Example 7 results in a compound that “includes two Boc-protected 3 Johansson et al., WO 99/41275, published Aug. 19, 1999. Appeal 2021-004210 Application 16/988,200 4 moieties,” which is only possible if the reactant is 4-(N-Boc-L- valyloxy)butyric acid rather than the un-protected 4-(L-valyloxy)butyric acid actually recited in that step in Johansson, and (2) Johansson’s Example 6 discloses a similar reaction in which the Boc-protected reactant, 4-(N-Boc-L- valyloxy)butyric acid, was used as the reactant. Id.; see also Reply Br. 4–7.4 While we understand Appellant’s position, Appellant has not provided persuasive evidence, such as declarations from skilled artisans, to support its arguments, relying instead on attorney arguments. “Attorney’s argument in a brief cannot take the place of evidence.” In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974). Neither do we find the error Appellant alleges in Johansson to be so obvious on the face of the reference that intrinsic evidence alone suffices to demonstrate the error. 4 In the Reply Brief, Appellant cites to other examples in Johansson alleged to be “consistent with . . . the introduction of [a] promoiety through acylation followed by N-deprotection of the N-protected promoiety to liberate the functionalized parent drug,” which Appellant contends supports its argument that the use of 4-(L-valyoxy)butyric acid in step (b) of Johansson’s Example 7 is clear error and that the correct compound is 4-(N- Boc-L-valyloxy)butyric acid. Reply Br. 7. Appellant further argues that Example 7 of Johansson states that “100mg, 0.33 mmol” of 4-(L- valyoxy)butyric acid was used in step (b), which is inconsistent with the molecular weight (203.24 g/mol) of that compound but would be consistent if 4-(N-Boc-L-valyloxy)butyric acid was the compound used. Id. at 8–9. Appellant raises these arguments for the first in a Reply Brief, thereby denying the Board the benefit of the Examiner’s response, and no showing of good cause was made to explain why the late argument should be considered by the Board. Accordingly, these arguments are waived. See 37 C.F.R. § 41.41(b)(2); cf. Optivus Tech., Inc. v. Ion Beam Applications S.A., 469 F.3d 978, 989 (Fed. Cir. 2006) (argument raised for the first time in the Reply Brief that could have been raised in the opening brief is waived). Appeal 2021-004210 Application 16/988,200 5 For these reasons, we are not persuaded by Appellant’s citation to In re Yale, 434 F.2d 666 (CCPA 1970). In that case, not only did the inconsistencies within the figures of the reference itself led the court to conclude that “[a] chemist of ordinary skill in the art would readily recognize that [the recited compound] must be an error,” appellant also submitted evidence that “the error in [the reference] would be apparent to one of ordinary skill in the art,” in the form of correspondence between a chemist to a co-author of the reference, “inquiring whether the list of [the compound in question] was a typographical error.” Id. at 669 (further noting that Fig. 1 of the reference “plots all the compounds except [the erroneously recited compound]”; that, except for the erroneously recited compound, “no compound not listed in Fig. 1 is plotted elsewhere”; that “[a] comparison of Fig. 3 and Fig. 1 shows that eight out of the nine compounds in Fig. 3 (except [the erroneous recited compound]) appear in Fig. 1”; and that “[a]ll eight have the identical Log P(f) in Fig. 3 that was listed for them in Fig. 1,” except the erroneously recited compound has the Log P(f) which was assigned in Fig. 1 to the “correct” compound). Similarly, appellants in Ex parte Darr and Ex parte Castan both submitted declarations, in addition to the references themselves, as evidence to explain why the disclosures relied upon by the Examiner comprise a clear typographical error. Ex parte Darr, Appeal No. 2011-011436 (PTAB October 21, 2013); Ex parte Castan, Appeal No. 2016-008209 (PTAB Oct. 5, 2017). Furthermore, although the panel in Ex parte Nutalapati does not rely on declarations from skilled artisans in reversing the Examiner’s rejection, unlike in this case the reference clearly shows the error on its face. Ex parte Nutalapati, Appeal 2018-004192 (PTAB July 29, 2019). For Appeal 2021-004210 Application 16/988,200 6 instance, as the Ex parte Nutalapati panel points out, although the Examiner relies on two instances in the reference in which a layer 17 is described as a “drug layer,” those instances occurred in a portion of the reference discussing drug-containing layer 16, and the reference elsewhere refers to layer 17 as a “push layer” that “does not contain drug.” Id. at 4–5. Accordingly, for the reasons discussed above, we affirm the Examiner’s rejection of claim 1 as anticipated by Johansson. CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/ Basis Affirmed Reversed 1 102(a)(1) Johansson 1 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation