URAT1 INHIBITOR AND USE THEREOF

§102 §112 §DP

DETAILED ACTION Claims 4-23 are pending in the present reissue application. Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Reissue Applications The present reissue application is a reissue of USPN 10,875,865 filed as U.S. Application 16/461,298. The present reissue application is also a continuing reissue application of USPN RE50,083 filed as U.S. Application 17/707,795. The specification of the present reissue application has not been amended so as to recite a cross reference to the prior reissue applications for the ‘865 patent, i.e., Serial No. 17/707,795. Additionally, the 17/707,795 specification has not been amended so as to recite a cross reference to the present application. 37 CFR 1.177(a) requires that all multiple reissue applications resulting from a single patent must include as the first sentence of their respective specifications a cross reference to the other reissue application(s). See MPEP 1451(I). Therefore, the present specification is objected to. Since the 17/707,795 application has issued as a reissue patent, the amendments to the specification should be taken care of by Applicant by certificate of correction. Claim Rejections - 35 USC § 251 The reissue oath/declaration filed with this application is defective (see 37 CFR 1.175 and MPEP § 1414) because of the following: The reissue declaration filed in the present reissue application is a copy of the reissue declaration filed in parent reissue application 17/707,795. However, the Applicant did not provide any explanation as to why the declaration filed in 17/707,795 is sufficient for the error being corrected by the present reissue application. Therefore, the reissue declaration is defective as the error identified by the reissue declaration was corrected by reissue application 17/707,795. If the Applicant files a new reissue declaration, they are also required to file a new consent of the assignee as the filing of a new reissue declaration is indicative of a new error being corrected. See MPEP 1451(II)(A). Claims 4-23 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175. The nature of the defect(s) in the declaration is set forth in the discussion above in this Office action. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 21 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 21 includes hydrolyzable prodrugs of compounds of claim 4, which are not allowed by parent claim 4. Therefore, claim 21 is broader than parent claim 4. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 4-10 and 20-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jain et al. (Arthritis and Rheumatism, 1974, 149-157). Jain et al. teach a single dose formulation of the compound PNG media_image1.png 142 350 media_image1.png Greyscale and its use to lower uric acid in patients with gout and hyperuricemia. See Figure 1, page 150 and Materials and Methods and Results, pages 149-155. The compound reads on the claims where the structure is PNG media_image2.png 130 256 media_image2.png Greyscale , the structure PNG media_image3.png 76 206 media_image3.png Greyscale , R1 is hydrogen, m is 1, Y is carbonyl, R2 is halogen, and R3 is ethyl. Claims 4-11 and 21-23 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Shi et al. (WO 2017/041732, all citations from English equivalent US PGPUB 2018/0282321). Shi et al. teaches the compounds PNG media_image4.png 128 162 media_image4.png Greyscale and PNG media_image5.png 128 174 media_image5.png Greyscale . See compound 4, page 6 and compound 74, page 20. The compounds read on claims 4-11 where the structure is PNG media_image6.png 124 236 media_image6.png Greyscale , the structure PNG media_image3.png 76 206 media_image3.png Greyscale , R1 is hydrogen, m is 1, Y is carbonyl, R2 is halogen or cyano, and R3 is ethyl. Compound 74 was formulated as a pharmaceutical composition with a pharmaceutically acceptable excipient/carrier to treat hyperuricemia in mice. See Example 34, pages 22-23. Therefore, claims 21-23 are anticipated. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 4-11 and 21-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,399,971. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons. The ‘971 patent claims the compounds PNG media_image4.png 128 162 media_image4.png Greyscale and PNG media_image5.png 128 174 media_image5.png Greyscale . See the first and last compounds of claim 7. The compounds anticipate claims 4-11 where the structure is PNG media_image6.png 124 236 media_image6.png Greyscale , the structure PNG media_image3.png 76 206 media_image3.png Greyscale , R1 is hydrogen, m is 1, Y is carbonyl, R2 is halogen or cyano, and R3 is ethyl. Claims 8 and 9 of the ‘971 patent are drawn to pharmaceutical compositions and a method of treating gout and hyperuricemia using the same compounds. Therefore, claims 21-23 are anticipated. Claims 4-16, 19, and 21-23 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. RE50,083. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons. Claim 1 of the ‘083 patent teaches the compounds PNG media_image7.png 102 140 media_image7.png Greyscale , PNG media_image8.png 100 140 media_image8.png Greyscale , PNG media_image9.png 96 148 media_image9.png Greyscale , PNG media_image10.png 96 140 media_image10.png Greyscale , PNG media_image11.png 104 140 media_image11.png Greyscale . See the second, fourth, sixth, ninth, thirteenth compounds. The compounds anticipate claims 4-11, 13, 15 and 19 where the structures are II-D, III-A, IV-A, or IV-D, the structure PNG media_image3.png 76 206 media_image3.png Greyscale , R1 is hydrogen, m is 1, Y is carbonyl or optionally substituted methylene, R2 is halogen or cyano, and R3 is ethyl. Additionally, the fourth, ninth, second, and sixth compounds are the same as claims 12, 14, and 16. Therefore, claims 12, 14, and 16 are anticipated. Claims 2 and 3 of the ‘083 patent are drawn to pharmaceutical compositions and a method of treating gout and hyperuricemia using the same compounds. Therefore, claims 21-23 are anticipated. Claims 4-11, and 21-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 18/867,411 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons. The ‘411 application claims a crystalline form of the compound PNG media_image12.png 94 128 media_image12.png Greyscale . Claims 1-17 of the ‘411 application anticipate present claims 4-11 where the structure is PNG media_image6.png 124 236 media_image6.png Greyscale , the structure PNG media_image3.png 76 206 media_image3.png Greyscale , R1 is hydrogen, m is 1, Y is carbonyl, R2 is cyano, and R3 is ethyl. Claims 18 and 21 of the ‘411 application are drawn to pharmaceutical compositions and a method of treating gout and hyperuricemia using the same compounds. Therefore, present claims 21-23 are anticipated. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Duty to Disclose Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 10,875,865 is or was involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation. Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application. These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04. Conclusion Claims 4-23 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joseph Kosack whose telephone number is (571)272-5575. The examiner can normally be reached M-F 8:00-4:30. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patricia Engle can be reached at 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. Signed: /JOSEPH R KOSACK/Patent Reexamination Specialist Central Reexamination Unit 3991 Conferees: /Alan Diamond/ /Patricia L Engle/ Patent Reexamination Specialist SPRS, CRU 3991 Central Reexamination Unit 3991