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
Status of claims
The amendment filed on August 20, 2025 is acknowledged. Claims 1-18, 20, 24-27 and 36 have been canceled. Claims 19, 21-23, and 28-35 are under examination in the instant office action.
Applicants' arguments, filed on August 20, 2025, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied in view of the amendments. They constitute the complete set presently being applied to the instant application. Responses are limited to Applicants' arguments relevant to either reiterated or newly applied rejections.
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 19, 21-23, 28, 31, and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2018/0044287 (hereafter, O'NEILL).
O’NEILL teaches sulfonyl ureas and related compounds including claimed compound:
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(N-((1,2,3,5,6,7-hexahydro-s-indacen-4-yl)carbamoyl)-1-isopropyl-1H-pyrazole-3-sulfonamide; MCC7840), which have advantageous properties and 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 autoinflammatory disorders (abstract, [0026], [0777]-[0778], [1021] and claims 36. 49, and 52). The compound is the only compound specifically tested in vivo ([1021], [1023]-[1025]).
O’NEILL teaches that the disease, disorder or condition includes cryopyrin-associated periodic syndrome (CAPS), Muckle-Wells syndrome (MWS), familial cold autoinflammatory syndrome (FCAS), neonatal-onset multisystem inflammatory disease (NOMID), and Schnitzler syndrome ([0354], claim 52). O’NEILL further teaches that the diseases include necrosis factor receptor (TNF) associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS), mevalonate kinase deficiency (MKD), familial mediterranean fever (FMF), Behcet’d Disease, Pyoderma Gangraenosum, systemic onset of juvenile idiopathic arthritis (sJIA), and Hidradenitis Suppurativa. ([0354] and claim 52).
O’NEILL teaches that the compounds of the present invention, by interrupting the function of NLRP3 inflammasomes in liver tissue, can cause histological reductions in liver inflammation, decreased recruitment of macrophages and neutrophils, and suppression of NF-κB activation ([0355]).
O’NEILL teaches that the compound has increased half-life and improved oral bioavailability and the routes of administration include oral administration ([0228], [326], and [1009]). O’NEILL specifically discloses oral administrating of the claimed compound, which is the only compound specifically tested for PK and oral bioavailability ([1021], [1022], Table 6, and Fig. 2B).
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 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
As such, the instant claims are anticipated by O’NEILL.
Response to Applicant’s arguments
Applicants argued while independent claim 19 as amended relates to a method for the treatment of specific autoinflammatory disorders comprising orally administering to a patient a specific compound or a salt thereof, US2018/0044287 does not discloses the specific compound claimed in the present application in combination with each and every one of the claimed features, namely the specific autoinflammatory disorders to be treatment and the specific (oral route of administration as required by the amended claims.
In response, US2018/0044287 specifically teaches and claims the claimed compound (N-((1,2,3,5,6,7-hexahydro-s-indacen-4-yl)carbamoyl)-1-isopropyl-1H-pyrazole-3-sulfonamide; MCC7840) (see abstract, [0026], [0777]-[0778], [1021] and claims 36. 49, and 52). Also, US2018/0044287 teaches “improved oral bioavailability” is one of benefits of their compounds (see [0228]) and specifically discloses oral administrating of the claimed compound, which is the only compound specifically tested for PK and oral bioavailability. See [1021], [1022], Table 6, and Fig. 2B. In addition, US2018/0044287 specifically teaches and claims the claimed specific autoinflammatory disorders (see [0354] and claim 52). Thus, one of ordinary skill in the art at once envisage a method of orally administering the claimed compound for treating the specific autoinflammatory disorders as recited in the instant claims. See MPEP 2131.02: A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)). In Kennametal, the challenged claim was to a cutting tool requiring a ruthenium binding agent with a physical vapor deposition (PVD) coating. The reference described all the elements of the claimed coated cutting tool but did not explicitly disclose the specific combination of ruthenium binding agent with a PVD coating. However, the reference disclosed that ruthenium was one of five specified binding agents and PVD was one of three suitable coating techniques. The Federal Circuit stated that the reference’s "express ‘contemplat[ion]’ of PVD coatings provided sufficient evidence that a reasonable mind could find that a person of skill in the art… would immediately envisage applying a PVD coating. Thus, substantial evidence supports the Board's conclusion that [the reference] effectively teaches 15 combinations, of which one anticipates pending claim 1. Though it is true that there is no evidence in [the reference] of ‘actual performance’ of combining the ruthenium binder and PVD coatings, this is not required." Kennametal, 780 F.3d at 1383, 114 USPQ2d at 1255 (citations omitted). See also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 851 F.3d 1270, 1274, 122 USPQ2d 1116, 1120 (Fed. Cir. 2017) ("Kennametal does not stand for the proposition that a reference missing a limitation can anticipate a claim if a skilled artisan viewing the reference would "at once envisage" the missing limitation. Rather, Kennametal addresses whether the disclosure of a limited number of combination possibilities discloses one of the possible combinations.").
For the foregoing reasons, Applicant’s arguments have not been found to be persuasive.
Claims 19, 21-23, and 28-35 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by WO 2019/206871 (hereafter, MILLER).
MILLER teaches a sodium salt of N-((1,2,3,5,6,7-hexahydro-s-indacen-4-yl)carbamoyl)-1-isopropyl-1H-pyrazole-3-sulfonamide (
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) and its use in the treatment and prevention of a medical disorder and disease, most especially by NLRP3 inhibition, which includes inflammation and auto-immune diseases (abstract and claims 1 and 19).
MILLER teaches that the diseases or disorders are cryopyrin-associated periodic syndrome (CAPS), Muckle-Wells syndrome (MWS), familial cold autoinflammatory syndrome (FCAS), neonatal-onset multisystem inflammatory disease (NOMID), or Schnitzler syndrome (claim 20).
MILLER further teaches that the diseases include necrosis factor receptor (TNF) associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS), mevalonate kinase deficiency (MKD), familial mediterranean fever (FMF), Behcet’d Disease, Pyoderma Gangraenosum, systemic onset of juvenile idiopathic arthritis (sJIA), and Hidradenitis Suppurativa (claim 20).
MILLER teaches that the compound can be orally administrated (p37, lines 28-32).
MILLER teaches that the sodium salt of the compound is a crystalline monosodium monohydrate salt (claims 1-5).
MILLER discloses a polymorphoic form of N-(1,2,3,5,6,7-hexahydro-s-indacen-4-yl)carbamoyl)-1-isopropyl-1H-pyrazole-3-sulfonamide monosodium salt monohydrate as Form 1, wherein the Form 1 typically has the same XRPD spectrum as claimed (claims 6-4).
MILLER teaches a pharmaceutical composition comprising the compound and a pharmaceutically acceptable excipient (claim 16). MILLER discloses that the composition is provided in the form of tablets, capsules, hard or soft gelatin capsules, caplets, troches or lozenges, as a powder or granules, or as an aqueous solution, suspension or dispersion for oral administration (p38, lines 4-7).
As such, the instant claims are anticipated by MILLER.
Response to Applicant’s arguments
Applicants argued while independent claim 19 as amended relates to a method for the treatment of specific autoinflammatory disorders comprising orally administering to a patient a specific compound or a salt thereof, WO 2019/206871 (MILLER) does not discloses the specific compound claimed in the present application in combination with each and every one of the claimed features, namely the specific autoinflammatory disorders to be treatment and the specific (oral route of administration as required by the amended claims.
In response, the only compound disclosed and claimed in Miller is a sodium salt of the claimed compound (N-((1,2,3,5,6,7-hexahydro-s-indacen-4-yl)carbamoyl)-1-isopropyl-1H-pyrazole-3-sulfonamide) in a crystalline form (see abstract and claims 1 and 6). Also, Miller explicitly teaches oral administration of the claimed compound and oral dosage forms (see p38, lines 4-26). In addition, Miller specifically teaches that NLRP3 has been implicated in claimed specific autoinflammatory diseases (see p20, lines 12-27) and claims the use of the claimed compound, which is an inhibitor of NLRP3 inflammasome, for treating claimed specific autoinflammatory disorders only (see [0354] and claim 20). Thus, one of ordinary skill in the art at once envisage a method of orally administering the claimed compound for treating the specific autoinflammatory disorders as recited in the instant claims. See MPEP 2131.02: A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)). In Kennametal, the challenged claim was to a cutting tool requiring a ruthenium binding agent with a physical vapor deposition (PVD) coating. The reference described all the elements of the claimed coated cutting tool but did not explicitly disclose the specific combination of ruthenium binding agent with a PVD coating. However, the reference disclosed that ruthenium was one of five specified binding agents and PVD was one of three suitable coating techniques. The Federal Circuit stated that the reference’s "express ‘contemplat[ion]’ of PVD coatings provided sufficient evidence that a reasonable mind could find that a person of skill in the art… would immediately envisage applying a PVD coating. Thus, substantial evidence supports the Board's conclusion that [the reference] effectively teaches 15 combinations, of which one anticipates pending claim 1. Though it is true that there is no evidence in [the reference] of ‘actual performance’ of combining the ruthenium binder and PVD coatings, this is not required." Kennametal, 780 F.3d at 1383, 114 USPQ2d at 1255 (citations omitted). See also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 851 F.3d 1270, 1274, 122 USPQ2d 1116, 1120 (Fed. Cir. 2017) ("Kennametal does not stand for the proposition that a reference missing a limitation can anticipate a claim if a skilled artisan viewing the reference would "at once envisage" the missing limitation. Rather, Kennametal addresses whether the disclosure of a limited number of combination possibilities discloses one of the possible combinations.").
For the foregoing reasons, Applicant’s arguments have not been found to be persuasive.
Double Patenting Rejections
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 19, 21-23, and 28-35 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-10, 12, and 21-32 of US 10973803.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘803 patent are drawn to a crystalline of N-((1,2,3,5,6,7-hexahydro-s-indacen-4-yl)carbamoyl)-1-isopropyl-1H-pyrazole-3-sulfonamide monosodium salt monohydrate having the same XRPD spectrum as claimed and its use for treating disease, disorder or condition responsive to NLRP3 inhibition, which includes cryopyrin-associated periodic syndrome (CAPS), Muckle-Wells syndrome (MWS), familial cold autoinflammatory syndrome (FCAS), neonatal-onset multisystem inflammatory disease (NOMID), Schnitzler syndrome, necrosis factor receptor (TNF) associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS), mevalonate kinase deficiency (MKD), familial mediterranean fever (FMF), Behcet’d Disease, Pyoderma Gangraenosum, and systemic onset of juvenile idiopathic arthritis (sJIA). It would have been obvious to use a suitable administration route for the compound.
As such, the instant claims would have been obvious over the claims of the patent.
Response to Applicant’s arguments
Applicants argued that US 10,973,803 is the granted US patent family member of WO2019/206871, thus the present claims are distinguished over WO2049/206871 for the reasons provided above.
For the same argument against WO2019/206871, the same responses are applied as stated above.
Claims 19, 21-23, and 35 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-34 of US 10538487 as evidenced by US 2018/0044287 (hereafter, O'NEILL).
Although the conflicting claims are not identical, they are not patentably distinct from each other because 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 was known in the art that the disease, disorder or condition responsive to inhibition of NLRP3 inflammasome include cryopyrin-associated periodic syndrome (CAPS), Muckle-Wells syndrome (MWS), familial cold autoinflammatory syndrome (FCAS), neonatal-onset multisystem inflammatory disease (NOMID), Schnitzler syndrome, necrosis factor receptor (TNF) associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS), mevalonate kinase deficiency (MKD), familial mediterranean fever (FMF), Behcet’d Disease, Pyoderma Gangraenosum, systemic onset of juvenile idiopathic arthritis (sJIA), and Hidradenitis Suppurativa as evidenced by O’NEILL ([0354] claim 52). O’NEILL also teaches that the compound has increased half-life and improved oral bioavailability and the routes of administration include oral administration ([0228], [326], and [1009]). Thus, it would have been prima facie obvious to use the compound of the patent for those diseases or disorders since they are diseases or disorders treatable by inhibition of NLRP3 inflammasome. Also, it would have been prima facie obvious to use a suitable administration route for the compound.
As such, the instant claims would have been obvious over the claims of the patent.
Claims 19, 21-23, and 35 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 8, 1-, 12, 14, 17-21, 24, 27, 30, 33, 36-40, and 53 of co-pending application 18/540743.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘743 application 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 cryopyrin-associated periodic syndrome (CAPS), Muckle-Wells syndrome (MWS), familial cold autoinflammatory syndrome (FCAS), neonatal-onset multisystem inflammatory disease (NOMID), Schnitzler syndrome, necrosis factor receptor (TNF) associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS), mevalonate kinase deficiency (MKD), familial mediterranean fever (FMF), Behcet’d Disease, Pyoderma Gangraenosum, and systemic onset of juvenile idiopathic arthritis (sJIA). See claims 36 and 40. It would have been obvious to use a suitable administration route for the compound.
As such, the instant claims would have been obvious over the claims of the co-pending application.
Response to Applicant’s arguments
Applicants argued that US 10,538,487 is the US patent granted on US application US2018/0044287 and USSN 18/540,743 is a continuation of US 10,538,487, thus the present claims are distinguished over US2018/0044287 for the reasons provided above.
For the same argument, the same responses as to US2018/0044287 are applied as stated above.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611