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 .
DETAILED ACTION
Applicant’s amendment filed on 08/20/2025, wherein claims 17, 22 have been amended, and claims 23, 32 have been cancelled.
Claims 17-22, 24-31 are pending, and examined herein.
Any rejection from the previous office action which is not restated here, is withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
1) Claims 17-21, 22, 24-31 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (WO 2019/206871, PTO-892 of record).
Miller et al. teaches the sodium salt of N-((1,2,3,5,6,7-hexahydro-s-indacen-4-yl)carbamoyl)-1-isopropyl-1H-pyrazole-3-sulfonamide (instant compound of formula (I) as in instant claim 17), hydrates, solvates and polymorphic forms thereof. See claims 1-7; page 5. Miller teaches the pharmaceutical compositions comprising this compound and the use of this compound in the treatment of medical disorders and diseases, most especially by NLRP3 inhibition. See abstract; page 1, lines 4-8; claims 1-7. It is taught that the said salt can be used in the treatment of condition responsive to NLRP3 inhibition such as rheumatoid arthritis, gout, pseudo-gout. See page 20, bottom para; page 21, lines 11-12; claims 20, 21. Miller teaches treatment of inflammatory responses occurring in connection with a joint condition such as osteoarthritis, rheumatoid arthritis, gout. See page 27, (ii); claim 19.
Miller teaches the salt is a monosodium salt; Miller teaches the salt is a monosodium monohydrate and crystalline i.e meets instant claims 24-28. See claims 1, 2, 3, 4, 5.
Miller teaches XRPD spectrum in which the 10 most intense peaks include 5 or more peaks which have an approximate 2q value selected from: 4.3 °2q, 6.2 °2q, 6.7 °2q, 7.3 °2q, 8.7 °2q, 9.0 °2q, 12.1 °2q, 15.8 °2q, 16.5 °2q, 18.0 °2q, 18.1 °2q, 20.6 °2q, 21.6 °2q, and 24.5 °2q i.e meets instant claims 29, 30. See claims 5-7.
Miller teaches for oral administration of the salt, hydrate, solvate, polymorphic form or pharmaceutical composition is generally provided in the form of tablets, capsules, hard or soft gelatine capsules, caplets, troches or lozenges, as a powder or granules, or as an aqueous solution, suspension or dispersion i.e meets oral administration as in instant claims 17, 31. See page 38, lines 4-7.
Miller et al. does not explicitly teach treating arthritis such as gout, pseudogout, rheumatoid arthritis, osteoarthritis comprising administering compound of formula (I) or a crystalline monosodium monohydrate salt thereof i.e does not provide an example.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer compound of formula (I) or a crystalline monosodium monohydrate salt thereof to a patient suffering from arthritis such as gout, pseudogout, rheumatoid arthritis, osteoarthritis because 1) Miller et al. teaches the sodium salt of N-((1,2,3,5,6,7-hexahydro-s-indacen-4-yl)carbamoyl)-1-isopropyl-1H-pyrazole-3-sulfonamide (instant compound of formula (I) as in instant claim 17); Miller teaches the salt is a monosodium monohydrate and crystalline and 2) Miller et al. teaches that said salt can be used in the treatment of condition responsive to NLRP3 inhibition such as rheumatoid arthritis, gout, pseudo-gout, osteoarthritis. One of ordinary skill in the art would be motivated to administer compound of formula (I) or a crystalline monosodium monohydrate salt thereof to a patient suffering from arthritis such as gout, pseudogout, rheumatoid arthritis, osteoarthritis with reasonable expectation of success of treating said arthritic conditions.
Regarding claim 22, Miller er al. renders obvious to administer compound of formula (I) or a crystalline monosodium monohydrate salt thereof to a patient suffering from arthritis such as gout, pseudogout, rheumatoid arthritis, osteoarthritis, and said administration will treat inflammation, since it is result or property of the compound on administration to a patient suffering from arthritis.
Response to Arguments
Applicant's arguments filed 08/20/2025 have been fully considered but they are not persuasive as discussed above and those found below.
Applicant argues that “W02019/206871 discloses a vast number of diseases (see claims 19- 20, and page 19 line 24 to page 29 line 36). Moreover, oral administration is mentioned amongst many other routes in a list of potential routes of administration (see page 37 line 28 to page 39 line 30).” Applicant’s arguments have been considered, but not found persuasive. It is pointed out that it has been well-established that consideration of a reference is not limited to the preferred embodiments or working examples, but extends to the entire disclosure for what it fairly teaches, when viewed in light of the admitted knowledge in the art, to person of ordinary skill in the art. See M.P.E.P. § 2123. Miller et al. teaches the sodium salt of N-((1,2,3,5,6,7-hexahydro-s-indacen-4-yl)carbamoyl)-1-isopropyl-1H-pyrazole-3-sulfonamide (instant compound of formula (I) as in instant claim 17), hydrates, solvates and polymorphic forms thereof. See claims 1-7; page 5. Miller teaches the pharmaceutical compositions comprising this compound and the use of this compound in the treatment of medical disorders and diseases, most especially by NLRP3 inhibition such as rheumatoid arthritis, gout, pseudo-gout. See page 20, bottom para; page 21, lines 11-12; claims 20, 21. Miller teaches for oral administration of the salt, hydrate, solvate, polymorphic form or pharmaceutical composition is generally provided in the form of tablets, capsules, hard or soft gelatine capsules, caplets, troches or lozenges, as a powder or granules, or as an aqueous solution, suspension or dispersion i.e meets oral administration as in instant claims 17, 31.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer compound of formula (I) or a crystalline monosodium monohydrate salt thereof orally to a patient suffering from arthritis such as gout, pseudogout, rheumatoid arthritis, osteoarthritis because 1) Miller et al. teaches the sodium salt of N-((1,2,3,5,6,7-hexahydro-s-indacen-4-yl)carbamoyl)-1-isopropyl-1H-pyrazole-3-sulfonamide (instant compound of formula (I) as in instant claim 17); Miller teaches the salt is a monosodium monohydrate and crystalline, 2) Miller et al. teaches that said salt can be used in the treatment of condition responsive to NLRP3 inhibition such as rheumatoid arthritis, gout, pseudo-gout, osteoarthritis, and 3) Miller teaches oral administration of the salt, hydrate, solvate, polymorphic form or pharmaceutical composition comprising the sodium salt of N-((1,2,3,5,6,7-hexahydro-s-indacen-4-yl)carbamoyl)-1-isopropyl-1H-pyrazole-3-sulfonamide (instant compound of formula (I). One of ordinary skill in the art would be motivated to administer orally compound of formula (I) or a crystalline monosodium monohydrate salt thereof to a patient suffering from arthritis such as gout, pseudogout, rheumatoid arthritis, osteoarthritis with reasonable expectation of success of treating said arthritic conditions.
Applicant argues that “many drugs are unsuitable for oral administration, for example, because of issues with oral bioavailability, solubility, dissolution and/or stability in the GI tract. However, the present inventors have found and demonstrated with data in the application as filed, that the claimed compound can be used successfully to treat arthritis by oral administration.” Applicant’s arguments have been considered, but not found persuasive as discussed above. Miller teaches oral administration of the compound therein. Miller teaches for oral administration of the salt, hydrate, solvate, polymorphic form or pharmaceutical composition is generally provided in the form of tablets, capsules, hard or soft gelatine capsules, caplets, troches or lozenges, as a powder or granules, or as an aqueous solution, suspension or dispersion i.e meets oral administration as in instant claims 17, 31.
2) Claims 17-21, 22, 24, 25, 27, 31 are rejected under 35 U.S.C. 103 as being unpatentable over O’Neill et al. (US 2018/0044287, PTO-892).
O’Neill teaches sulfonyl ureas and related compounds which have advantageous properties and show useful activity in the inhibition of activation of the NLRP3 inflammasome. See abstract; claims 39, 40, 52. O’Neill teaches instant compound of formula I and pharmaceutically acceptable salts thereof such as sodium salt (see para [0310]). See MCC7840, para [1023]; paras [0777]-[0778]; page 20, right hand column; page 168, claim 36. It is taught that the compounds therein show useful activity in the inhibition of activation of the NLRP3 inflammasome and their use for treating a disease, disorder or condition responsive to inhibition of activation of the NLRP3 inflammasome including rheumatoid arthritis, gout, pseudo-gout, osteoarthritis. See abstract; paras [0026], [1021]; and claims 36. 39, 40, and 52. The compound is the only compound specifically tested in vivo ([1021], [1023]-[1025]).
O’NEILL teaches that a salt of the compound includes sodium salt ([0310]); O’NEILL teaches that the compounds may exist in stable and metastable crystalline forms ([0308] and [0777]-[0778]).
O’NEILL teaches that the compound has increased half-life and improved oral bioavailability and the routes of administration include oral administration ([0228], [0326], and [1009]). O’NEILL teaches that a pharmaceutical composition comprising the compound or a pharmaceutically acceptable salt and a pharmaceutically acceptable carrier, diluent and/or excipient ([0022]). O’NEILL teaches that the composition may be in the form of a tablet or capsule ([0321]), which is suitable for oral administration.
O’NEILL does not explicitly teach treating arthritis such as gout, pseudogout, rheumatoid arthritis, osteoarthritis comprising administering compound of formula (I) or monosodium salt thereof i.e does not provide an example.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer compound of formula (I) or a monosodium salt thereof to a patient suffering from arthritis such as gout, pseudogout, rheumatoid arthritis, osteoarthritis because 1) O’Neill teaches instant compound of formula (I) and pharmaceutically acceptable salts such as sodium salt, and 2) O’Neill teaches that the compounds therein show useful activity in the inhibition of activation of the NLRP3 inflammasome and their use for treating a disease, disorder or condition responsive to inhibition of activation of the NLRP3 inflammasome including rheumatoid arthritis, gout, pseudo-gout, osteoarthritis. One of ordinary skill in the art would be motivated to administer compound of formula (I) or a monosodium salt thereof to a patient suffering from arthritis such as gout, pseudogout, rheumatoid arthritis, osteoarthritis with reasonable expectation of success of treating said arthritic conditions.
Regarding claim 22, O’Neill et al. renders obvious to administer compound of formula (I) or a sodium salt thereof to a patient suffering from arthritis such as gout, pseudogout, rheumatoid arthritis, osteoarthritis, and said administration will treat inflammation, since it is result or property of the compound on administration to a patient suffering from arthritis.
Response to Arguments
Applicant's arguments filed 08/20/2025 have been fully considered but they are not persuasive as discussed above and those found below.
Applicant argues that “US2018/0044287 discloses a vast number of compounds (see the Markush structure of claim 1, and the example compounds in paragraphs [0646]-[0984]) and a vast number of diseases (see claims 39-52 and paragraphs [0331]-[0358]). Applicant argues that “US2018/0044287 does not disclose the specific compound claimed in the present application in combination with each and everyone of the claimed features, namely the arthritis to be treated and the specific (oral) route of administration, as required by the amended claims.” Applicant’s arguments have been considered, but not found persuasive. It is pointed out that it has been well-established that consideration of a reference is not limited to the preferred embodiments or working examples, but extends to the entire disclosure for what it fairly teaches, when viewed in light of the admitted knowledge in the art, to person of ordinary skill in the art. See M.P.E.P. § 2123. O’Neill teaches instant compound of formula I and pharmaceutically acceptable salts thereof such as sodium salt (see para [0310]). See MCC7840, para [1023]; paras [0777]-[0778]; page 20, right hand column; page 168, claim 36. It is taught that the compounds therein show useful activity in the inhibition of activation of the NLRP3 inflammasome and their use for treating a disease, disorder or condition responsive to inhibition of activation of the NLRP3 inflammasome including rheumatoid arthritis, gout, pseudo-gout, osteoarthritis. See abstract; paras [0026], [1021]; and claims 36. 39, 40, and 52. The compound is the only compound specifically tested in vivo ([1021], [1023]-[1025]). O’NEILL teaches that the compound has increased half-life and improved oral bioavailability and the routes of administration include oral administration ([0228], [0326], and [1009]). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer compound of formula (I) or a monosodium salt thereof orally to a patient suffering from arthritis such as gout, pseudogout, rheumatoid arthritis, osteoarthritis because 1) O’Neill teaches instant compound of formula (I) and pharmaceutically acceptable salts such as sodium salt, 2) O’Neill teaches that the compounds therein show useful activity in the inhibition of activation of the NLRP3 inflammasome and their use for treating a disease, disorder or condition responsive to inhibition of activation of the NLRP3 inflammasome including rheumatoid arthritis, gout, pseudo-gout, osteoarthritis, and 3) O’NEILL teaches that the compound has increased half-life and improved oral bioavailability and the routes of administration include oral administration ([0228], [0326], and [1009]). One of ordinary skill in the art would be motivated to administer orally compound of formula (I) or a monosodium salt thereof to a patient suffering from arthritis such as gout, pseudogout, rheumatoid arthritis, osteoarthritis with reasonable expectation of success of treating said arthritic conditions.
Applicant argues that “many drugs are unsuitable for oral administration, for example, because of issues with oral bioavailability, solubility, dissolution and/or stability in the GI tract. However, the present inventors have found and demonstrated with data in the application as filed, that the claimed compound can be used successfully to treat arthritis by oral administration.” Applicant’s arguments have been considered, but not found persuasive as discussed above. O’Neill teaches instant compound of formula I and pharmaceutically acceptable salts thereof such as sodium salt (see para [0310]). See MCC7840, para [1023]; paras [0777]-[0778]; page 20, right hand column; page 168, claim 36. O’NEILL teaches that the compound therein has increased half-life and improved oral bioavailability and the routes of administration include oral administration ([0228], [0326], and [1009]).
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.
1)Claims 17-22, 24-25, 31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21, 25-34 of U.S. Patent No. 10,538,487. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claims are drawn to a method for the treatment of arthritis in a patient in need thereof, wherein the method comprises administering to the patient in need thereof a therapeutically effective amount of a compound of formula (I) or a pharmaceutically acceptable salt thereof; wherein the arthritis is gout, pseudogout, rheumatoid arthritis or osteoarthritis; wherein the compound or salt is a sodium salt.
The claims of ‘487 patent are drawn to sulfonylurea compounds including the same compound (N-((1,2,3,5,6,7-hexahydro-s-indacen-4-yl)carbamoyl)-1-isopropyl-1H-pyrazole-3-sulfonamide) as claimed; and a method of treating disease, disorder or condition responsive to inhibition of NLRP3 inflammasome.
It is pointed out that the method of the present invention utilizes the compounds of '487, and specification in ‘487 teaches that the compounds or sodium salts therein are useful in the method as instantly claimed, thus the inventions are considered obvious over one another. Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. court, “[i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, ... and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted … .”
See Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385. In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context.
Response to Arguments
Applicant's arguments filed 08/20/2025 have been fully considered but they are not persuasive as discussed above under 35 U.S.C. 103 rejection over US2018/0044287. The same reasons apply for this rejection.
2)Claims 17-22, 24-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 10,973,803. Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claims are drawn to a method for the treatment of arthritis in a patient in need thereof, wherein the method comprises administering to the patient in need thereof a therapeutically effective amount of a compound of formula (I) or a pharmaceutically acceptable salt thereof; wherein the arthritis is gout, pseudogout, rheumatoid arthritis or osteoarthritis; wherein the compound or salt is a sodium salt.
The claims of ‘803 patent are drawn to sulfonylurea compounds including the same compound (N-((1,2,3,5,6,7-hexahydro-s-indacen-4-yl)carbamoyl)-1-isopropyl-1H-pyrazole-3-sulfonamide) as claimed or a crystalline monosodium monohydrate salt has an XRPD spectrum as in instant claims 29, 30; and a method of treating disease, disorder or condition responsive to inhibition of NLRP3 inflammasome.
It is pointed out that the method of the present invention utilizes the compounds of '803, and specification in ‘803 teaches that the compounds therein are useful in the method as instantly claimed, thus the inventions are considered obvious over one another. Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. court, “[i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, ... and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted … .”
See Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385. In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context.
Response to Arguments
Applicant's arguments filed 08/20/2025 have been fully considered but they are not persuasive as discussed above under 35 U.S.C. 103 rejection over WO2019/206871. The same reasons apply for this rejection.
3)Claims 17-22, 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 12, 14, 17-18, 20, 36-40, and 53 of co-pending application 18/540,743 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claims are drawn to a method for the treatment of arthritis in a patient in need thereof, wherein the method comprises administering to the patient in need thereof a therapeutically effective amount of a compound of formula (I) or a pharmaceutically acceptable salt thereof; wherein the arthritis is gout, pseudogout, rheumatoid arthritis or osteoarthritis; wherein the compound or salt is a sodium salt.
Claims of ‘743 are drawn to sulfonylurea compounds including the same compound (N-((1,2,3,5,6,7-hexahydro-s-indacen-4-yl)carbamoyl)-1-isopropyl-1H-pyrazole-3-sulfonamide) as claimed; and its use for treating disease, disorder or condition responsive to inhibition of NLRP3 inflammasome, which includes arthritis is gout, pseudogout, rheumatoid arthritis or osteoarthritis. See claims 36 and 40.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer compound of formula (I) or a salt thereof to a patient suffering from arthritis such as gout, pseudogout, rheumatoid arthritis, osteoarthritis because ‘743 teaches sulfonylurea compounds including the same compound (N-((1,2,3,5,6,7-hexahydro-s-indacen-4-yl)carbamoyl)-1-isopropyl-1H-pyrazole-3-sulfonamide) as claimed; and its use for treating disease, disorder or condition responsive to inhibition of NLRP3 inflammasome, which includes arthritis is gout, pseudogout, rheumatoid arthritis or osteoarthritis.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 08/20/2025 have been fully considered but they are not persuasive as discussed above under 35 U.S.C. 103 rejection over US2018/0044287. The same reasons apply for this rejection.
4)Claims 17-22, 24-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19, 21-23, 28-35 of co-pending application 17/775,230 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claims are drawn to a method for the treatment of arthritis in a patient in need thereof, wherein the method comprises administering to the patient in need thereof a therapeutically effective amount of a compound of formula (I) or a pharmaceutically acceptable salt thereof; wherein the arthritis is gout, pseudogout, rheumatoid arthritis or osteoarthritis; wherein the compound or salt is a sodium salt.
Claims of ‘230 are drawn a method for the treatment or prevention of an autoinflammatory disorder in a patient in need thereof, wherein the method comprises administering to the patient in need thereof a therapeutically or prophylactically effective amount of a compound of formula (I) which is same as instant compound; autoinflammatory disorder includes treating systemic onset of juvenile idiopathic arthritis.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer compound of formula (I) or a salt thereof to a patient suffering from arthritis such as gout, pseudogout, rheumatoid arthritis, osteoarthritis because ‘230 teaches a method for the treatment or prevention of an autoinflammatory disorder in a patient in need thereof, wherein the method comprises administering to the patient in need thereof a therapeutically or prophylactically effective amount of a compound of formula (I) which is same as instant compound; autoinflammatory disorder includes treating systemic onset of juvenile idiopathic arthritis.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 08/20/2025 have been fully considered but they are not persuasive as discussed above. Note : Applicant defers comment.
Prior Art made of Record:
AR 110623 A1
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHOBHA KANTAMNENI, Ph.D whose telephone number is (571)272-2930. The examiner can normally be reached on Monday to Friday; 8.00 am-4.30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel, Ph.D can be reached on 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHOBHA KANTAMNENI/Primary Examiner, Art Unit 1627