REATA PHARMACEUTICALS, INC.

Patent Trials and Appeals BoardJan 27, 2021

2020004290 (P.T.A.B. Jan. 27, 2021)

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. 15/791,677 10/24/2017 Eric ANDERSON REAT.P0018US.C1 9299 108197 7590 01/27/2021 Parker Highlander PLLC 1120 South Capital of Texas Highway Bldg. 1, Suite 200 Austin, TX 78746 EXAMINER BADIO, BARBARA P ART UNIT PAPER NUMBER 1628 NOTIFICATION DATE DELIVERY MODE 01/27/2021 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): docket@phiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ERIC ANDERSON, GARY L. BOLTON, DEBORAH A. FERGUSON, XIN JIANG, ROBERT M. KRAL, PATRICK M. O'BRIEN, and MELEAN VISNICK Appeal 2020-004290 Application 15/791,677 Technology Center 1600 Before ERIC B. GRIMES, JOHN E. SCHNEIDER, and MICHAEL A. VALEK, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 174, and 178–181.2 See Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b). We Affirm. 1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Reata Pharmaceuticals, Inc. Appeal Br. 3. 2 Claims 182–184 are pending in the present application but have been withdrawn from consideration as being directed to a nonelected species. Final Act. 2. Appeal 2020-004290 Application 15/791,677 2 CLAIMED SUBJECT MATTER The claims are directed to natural product analogs including an anti- inflammatory cyanoenone pharmacore and related methods. Claim 174, reproduced below, is illustrative of the claimed subject matter: 174. A method of making a compound comprising: a) a basic skeleton of an organic compound having two to eight five and/or six-membered rings provided that the basic skeleton is not the basic skeleton of argentatin, betulinic acid, lanostane, oleanic acid, boswellic acid, glycyrrhetinic acid, ursolic acid, or tricyclic-bis-enone; b) a structural unit of the formula: wherein: the carbon atoms labeled 1, 2 and 3 are part of a five or six-membered ring; X is cyano or -C(O)Ra, wherein Ra is: hydrogen, hydroxy, halo, ammo, hydroxyamino, azido or mercapto; or alkyl(c≤12), alkenyl(c≤12), alkynyl(c≤12), aryl(c≤12), aralkyl(c≤12), heteroaryl(c≤12), heteroaralkyl(c≤12), alkoxy(c≤12), alkenyl-oxy(c≤12), heteroaralkoxy(c≤12), acyloxy(c≤12), alkylamino(c≤12), dialkylamino(c≤12), alkoxyamino(c≤12), alkenylamino(c≤12), alkynylamino(c≤12), arylamino(c≤12), aralkylamino(c≤12), heteroarylamino(c≤12), heteroaralkylamino(c≤12), alkylsulfonylamino(c≤12), amido(c≤12), alkyl-silyloxy(c≤12), or substituted versions of any of these groups; and R1 and R2 are each independently: Appeal 2020-004290 Application 15/791,677 3 hydrogen; or alkyl(c≤12), alkenyl(c≤12), alkynyl(c≤12), aryl(c≤12), aralkyl(c≤12), heteroaryl(c≤12), heteroaralkyl(c≤12), acyl(c≤12), alkoxy(c≤12), aryloxy(c≤12), aralkoxy(c≤12), heteroaryloxy(c≤12), heteroaralkoxy(c≤12), acyloxy(c≤12), alkylamino(c≤12), dialkylammo(c≤12), arylamino(c≤12), aralkylamino(c≤12), heteroarylamino(c≤12), heteroaralkylamino(c≤12), amido(c≤12), or a substituted version of any of these groups; or R1 and R2 are taken together and are alkanediyl(c≤12), alkenediyl(c≤12), alkanediyl(c≤12) or alkenediyl(c≤12); and c) from 0 to 8 chemical groups attached to a carbon atom of the basic skeleton other than carbon atoms 1, 2, 3 or 4, wherein each chemical group is independently: hydroxy, halo, oxo, amino, hydroxyamino, nitro, imino, cyano, azido, mercapto, or thio; or alkyl(c≤12), alkenyl(c≤12), alkynyl(c≤12), aryl(c≤12), aralkyl(c≤12), heteroaryl(c≤12), heteroaralkyl(c≤12), acyl(c≤12), alkylidene(c≤12), alkoxy(c≤12), alkenyloxy(c≤12), alkynyloxy(c≤12), aryloxy(c≤12), aralkoxy(c≤12), heteroaryloxy(c≤12), heteroaralkoxy(c≤12), acyloxy(c≤12), alkylamino(c≤12), dialkylamino(c≤12), alkoxyamino(c≤12), alkenylamino(c≤12), alkynylamino(c≤12), arylamino(c≤12), aralkylammo(c≤12), heteroarylamino(c≤12), heteroaralkylamino(c≤12), alkylsulfonylamino(c≤12), amido(c≤12), alkylimino(c≤12), alkenylimino(c≤12), alkynylimino(c≤12), arylimino(c≤12), aralkylimino(c≤12), heteroarylimino(c≤12), heteroaralkylimino(c≤12), acylimino(c≤12), alkylthio(c≤12), alkenylthio(c≤12), alkynylthio(c≤12), arylthio(c≤12), aralkylthio(c≤12), heteroarylthio(c≤12), heteroaralkylthio(c≤12), acylthio(c≤12), thioacyl(c≤12), alkylsulfonyl(c≤12), alkenylsulfonyl(c≤12), alkynylsulfonyl(c≤12), arylsulfonyl(c≤12), aralkylsulfonyl(c≤12), heteroarylsulfonyl(c≤12), heteroaralkylsulfonyl(c≤12), alkylammoni umcco::12), alkylsulfonium(c≤12), alkylsilyl(c≤12), alkylsilyloxy(c≤12), or a substituted version of any of these groups; or pharmaceutically acceptable salts, esters, hydrates, solvates, tautomers, acetals, ketals, prodrugs, or optical isomers thereof, Appeal 2020-004290 Application 15/791,677 4 the method comprising: (a) obtaining an organic compound having two to eight five and/or six-membered rings, provided that the organic compound is not argentatin, betulinic acid, lanostane, oleanic acid, boswellic acid, glycyrrhetinic acid, ursolic acid, or tricyclic-bis-enone; (b) reacting the organic compound in a series of one of more steps to obtain the compound, wherein the compound’s induction of Nrf2 activity is at least ten times higher than the organic compound's induction of Nrf2 activity, the compound’s inhibition of NF-KB activity is at least ten times higher than the organic compound’s inhibition of NF-KB activity, and/or the compound’s inhibition of IFNγ- induced NO activity is at least ten times higher than the organic compound’s inhibition of IFNγ-induced NO activity. Appeal Br. 21–23 (Claims Appendix). REJECTIONS3 Claims 174 and 178–181 are rejected under 35 U.S.C. 112, first paragraphas failing to comply with the written description requirement. Claims 174 and 178–181 are rejected under 35 U.S.C. 112, second paragraph as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. OPINION Written Description 3 In the Final Action, the Examiner rejected claims 174 and 178–181 for nonstatutory obviousness-type double-patenting and as anticipated by Orr et al. Final Act. 2, 11. These rejection have been withdrawn by the Examiner. Ans. 8–9. Appeal 2020-004290 Application 15/791,677 5 The Examiner finds The claims lack identification of the (i) organic compound, i.e., starting material, (ii) reaction step(s) and/or (ii) [sic, (iii)] the compound produced and, thus, fail to comply with the written description requirement because they contain subject matter not described in the specification to reasonabl[y] convey that applicant had possession of the full scope of the claimed invention. Final Act. 8.4 Appellant contends that the present Specification provides numerous chemical schemes corresponding to species that are covered by the present claims. Appeal Br. 11, Reply Br. 2. Appellant contends that the law only requires disclosure of a representative number of adequately described species that are representative of the genus. Appeal Br. 14. Appellant contends that it has met this requirement. Id. at 15. We have considered the arguments presented by the Examiner and Appellant and find that the Examiner has the better positon. 4 We note that much of the Examiner’s analysis is couched in terms of a failure to describe the invention in “full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make” the invention. Final Act. 7–8. This is the standard for enablement which is separate from the written description requirement. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)( “[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’”); Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 963 (Fed. Cir. 2002). The proper standard for determining whether the written description requirement has been met is whether the Specification “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). Appeal 2020-004290 Application 15/791,677 6 A description adequate to satisfy 35 U.S.C. § 112, first paragraph, “must ‘clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.’ In other words, the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). “One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus.” AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300 (Fed. Cir. 2014). Claim 178 calls for a starting material comprising “a basic skeleton of an organic compound having two to eight five and/or six member rings” and then excludes certain structures. Appeal Br. 21 (Claims App’x.). While Appellant contends that the Specification discloses “numerous” examples of such compounds, Appellant only points to reaction schemes for making two compounds with two six member rings and one compound with six 5- and 6- member rings, from the corresponding starting materials. See id. at 12–13. Similarly, the claims recite “reacting the organic compound in a series of one or more steps to obtain the compound.” Id. at 23. Again, Appellant points only to three reaction schemes which use three different starting compounds to produce four different end products. See id. at 12–13; Spec. at 115–117 and 122–124. The reactions employ different reagents, reaction conditions and numbers of steps. Id. Other than the reaction schemes used in Appeal 2020-004290 Application 15/791,677 7 the examples, the Specification does not provide any description of the reaction conditions that can be used other than to suggest the use of general chemical principles and techniques. Spec. 68. This suggests at best a research plan for others to follow rather that show that the inventors had in their possession a representative number of reaction schemes to support the broad limitation calling for “reacting the organic compound in a series of one of more steps to obtain the compound.” See AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300 (Fed. Cir. 2014). The claims also call for a final product wherein the compound’s induction of Nrf2 activity is at least ten times higher than the organic compound's induction of Nrf2 activity, the compound’s inhibition of NF-kB activity is at least ten times higher than the organic compound’s inhibition of NF- kB activity, and/or the compound’s inhibition of IFNγ-induced NO activity is at least ten times higher than the organic compound’s inhibition of IFNγ-induced NO activity. Appeal Br. 23. Here again, the genus of compounds that would meet this limitation of very large. The Specification only describes four specific products which meet this functional limitation. See Spec. at 115–117, and 122–124. Nor is there sufficient evidence before us to demonstrate a correlation between the structure of a compound and recited function such that a skilled artisan could recognize those compounds that would meet this functional requirement. Given the breath of the genus we find that disclosure of three compounds is insufficient to support the genus. See Ariad, 598 F.3d at 1349 (“[T]he specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.”). Appeal 2020-004290 Application 15/791,677 8 Based on the foregoing we conclude that the Examiner properly determined that the present claims fail to meet the written description requirement of 35 U.S.C. § 112. Indefiniteness The Examiner has rejected the pending claims as indefinite for failure to “particularly point out and distinctly claim the subject matter which the applicant regards as his invention.” Final Act. 10–11. The Examiner finds that “the skilled artisan would be unable to readily recognize the chemical reactions and the starting material(s) necessary to produce a compound only defined by a partial ring.” Id. at 10. Appellant contends that the claims are not indefinite. Appeal Br. 15– 18. With respect to the starting materials, Appellant contends that the partial structure recited in the claims is sufficient to inform one skilled in the art of the boundaries of the claims. Id. at 16. Appellant contends that one skilled in the art would also be able to determine if the finished product met the claim limitations. Id. at 16–17. Finally, Appellant contends that one skilled in the art would be able to recognize which reactions would yield the compounds defined in the claims. Id. at 17–18. Applying the broadest reasonable interpretation of a claim the Office establishes a prima facie case of indefiniteness with a rejection explaining how the metes and bounds of a pending claim are not clear because the claim contains words or phrases whose meaning is unclear. See In re Packard, 751F.3d1307, 1310 (Fed. Cir. 2014) We have considered the arguments presented by the Examiner and Appellant and conclude that Appellant has the better positon. Appeal 2020-004290 Application 15/791,677 9 The Examiner contends that “the skilled artisan would be unable to readily recognize the chemical reactions and the starting material(s) necessary to produce a compound only defined by a partial ring.” Ans. 17. The Examiner does not offer any evidence or persuasive argument to support this positon other than to argue that one skilled in the art would not be able to determine the difference between the starting and ending compounds without knowing the specific reaction steps. Id. at 19. We are not persuaded by the Examiner’s argument. Claim 1 defines the starting materials as “an organic compound having two to eight five and/or six-membered rings, provided that the organic compound is not argentatin, betulinic acid, lanostane, oleanic acid, boswellic acid, glycyrrhetinic acid, ursolic acid, or tricyclic-bis-enone.” Appeal Br. 23 (Claims App’x). While the genus of compounds that meet this limitation is fairly broad, breadth alone does not render the claim indefinite. “[B]readth is not to be equated with indefiniteness.” In re Miller, 441 F.2d 689, 693 (CCPA 1971). The same is true for the final product. The final product must have a backbone similar to the starting material and must have, as part of its overall structure, a structure that meets the partial structure recited in the claims. We agree with Appellant that one skilled in the art would be able to determine the final product had a backbone comprising two to eight five and/or six member rings that are not argentatin, betulinic acid, lanostane, oleanic acid, boswellic acid, glycyrrhetinic acid, ursolic acid, or tricyclic- bis-enone, and whether the finished product possessed the partial structure recited in the claims. Appeal Br. 17. Again, while the genus of compounds Appeal 2020-004290 Application 15/791,677 10 that meet this limitation might be broad, that does not render the claims indefinite. Finally, with respect to the reaction steps, again we agree with Appellant that the broad limitation does not render the claims indefinite. Appeal Br. 17–18. The Specification teaches that the steps that can be employed are known in the art. Spec. 68. We agree that one skilled in the art would be able to determine which steps can be used to produce the desired end product. Appeal Br. 17–18; Reply Br. 7. Based in the forgoing we conclude that the Examiner erred in finding that the rejected claims are unpatentable under 35 U.S.C. §112(b) as indefinite. CONCLUSION The Examiner’s rejection is affirmed. The Examiner’s decision to reject claims 174 and 178–181 under 35 U.S.C. § 112, first paragraph for failure to comply with the written description requirement is affirmed. The Examiner’s decision to reject claims 174 and 178–181 under 35 U.S.C. § 112, second paragraph as indefinite is reversed. Appeal 2020-004290 Application 15/791,677 11 DECISION SUMMARY Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 174, 178– 181 112, first paragraph Written Description 174, 178– 181 174, 178– 181 112, second paragraph Indefiniteness 174, 178– 181 Overall Outcome 174, 178– 181 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). AFFIRMED