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 .
Claims 36-42 are presented for examination.
Applicants’ drawings, information disclosure statements, and preliminary amendment filed August 14, 2025 have been received and entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
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 36-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,874,647 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented application teaches an immediate release pharmaceutical composition comprising rifaximin, HPMC-AS, poloxamer 407, croscarmellose sodium, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate (A product), and the present application teaches a method of use claims containing the pharmaceutical composition in an immediate release tablet unit dosage form comprising an amorphous sold dispersion comprising rifaximin and an inert carrier matrix (the inert carrier is hydrophilic and polymer(s)), and one or more ingredients selected from the groups consisting of a dissolution enhancer, a filler, a glidant, and a lubricant of the patented application therein which makes the pharmaceutical composition claims of the patented application an obvious variation of the present claims.
Note in the patented application, HPMC-AS is a hydrophilic polymer (an inert carrier). Also note in the patented application that the rifaximin, polymer and menthol are mixed and then spray dried.
Claims 36-42 are not allowed.
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 36-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,129,817 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented application teaches a method of preventing complications of liver disease in a subject having liver cirrhosis comprising administering to the subject a pharmaceutical composition comprising from about 16 wt % to about 18 wt % rifaximin; from about 16 wt % to about 18 wt % HPMC-AS; from about 1 wt % to about 2 wt % poloxamer 407; from about 8 wt % to about 10 wt % croscarmellose sodium; from about 49 wt % to about 51 wt % microcrystalline cellulose; from about 0.15 wt % to about 0.25 wt % colloidal silicon dioxide; and from about 0.45 wt % to about 0.55 wt % magnesium stearate, wherein the total amount of rifaximin is 40 mg wherein the pharmaceutical composition is an immediate release composition in the form of a tablet, and the present application teaches a method of preventing complications of liver disease in a subject having liver cirrhosis comprising administering to the subject an immediate-release tablet comprising: (a) an amorphous solid dispersion comprising 40 mg of rifaximin and an inert carrier matrix; and (b) one or more ingredients selected from the group consisting of a dissolution enhancer, a filler, a glidant, and a lubricant with same complications of liver disease as the patented application.
Note in the patented application, HPMC-AS is a hydrophilic polymer (an inert carrier). Also note in the patented application that the rifaximin, polymer and menthol are mixed and then spray dried.
Claims 36-42 are not allowed.
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 36-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,311,521 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented application teaches a method of preventing complications of liver disease in a subject having liver cirrhosis comprising administering to the subject an immediate release pharmaceutical composition comprising from about 16 wt % to about 18 wt % rifaximin; from about 16 wt % to about 18 wt % HPMC-AS; wherein the total amount of rifaximin is 40 mg wherein the pharmaceutical composition is in the form of a tablet, and the present application teaches a method of preventing complications of liver disease in a subject having liver cirrhosis comprising administering to the subject an immediate-release tablet comprising: (a) an amorphous solid dispersion comprising 40 mg of rifaximin and an inert carrier matrix; and (b) one or more ingredients selected from the group consisting of a dissolution enhancer, a filler, a glidant, and a lubricant with same complications of liver disease as the patented application.
Note in the patented application, HPMC-AS is a hydrophilic polymer (an inert carrier). Also note in the patented application that the rifaximin, polymer and menthol are mixed and then spray dried.
Claims 36-42 are not allowed.
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 36-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 11,660,292 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented application teaches an immediate release pharmaceutical composition comprising rifaximin, and HPMC-AS in tablet form and the present application teaches a pharmaceutical composition in immediate release tablet unit dosage form comprising an amorphous sold dispersion comprising rifaximin and an inert carrier matrix (the inert carrier is hydrophilic and polymer(s)), and one or more ingredients selected from the groups consisting of a dissolution enhancer, a filler, a glidant, and a lubricant.
Note in the patented application, HPMC-AS is a hydrophilic polymer (an inert carrier). Note in the patented application, the immediate release pharmaceutical composition also contains one or more ingredients selected from the groups consisting of a dissolution enhancer, a filler, a glidant, and a lubricant.
Also note in the patented application that the rifaximin, polymer and menthol are mixed and then spray dried.
Claims 36-42 are not allowed.
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 36-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of copending Application No. 18/958,759 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application teaches a pharmaceutical composition comprising rifaximin, HPMC-AS, poloxamer, croscarmellose sodium, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate in tablet form and is immediate release (A product), and the present application teaches a method of use claims containing the instant pharmaceutical composition of the copending application therein which makes the composition claims of the copending application an obvious variation of the present claims.
Note in the copending application, HPMC-AS is a hydrophilic polymer (an inert carrier). Note in the copending application, the immediate release pharmaceutical composition also contains one or more ingredients selected from the groups consisting of a dissolution enhancer, a filler, a glidant, and a lubricant.
Also note in the copending application that the rifaximin, polymer and menthol are mixed and then spray dried.
Claims 36-42 are not allowed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 36-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 36-42 of copending Application No. 19/299,544 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application teaches a pharmaceutical composition in an immediate release tablet comprising: (a) an amorphous solid dispersion comprising 40 mg of rifaximin and an inert carrier matrix; and (b) one or more ingredients selected from the groups consisting of a dissolution enhancer, a filler, a glidant, and a lubricant (A product), and the present application teaches a method of use claims containing the instant pharmaceutical composition of the copending application therein which makes the composition claims of the copending application an obvious variation of the present claims.
Note in the copending application, HPMC-AS is a hydrophilic polymer (an inert carrier). Note in the copending application, the immediate release pharmaceutical composition also contains one or more ingredients selected from the groups consisting of a dissolution enhancer, a filler, a glidant, and a lubricant.
Also note in the copending application that the rifaximin, polymer and menthol are mixed and then spray dried.
Claims 36-42 are not allowed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 36 and 38-41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by AU 2016203925 A1, hereby known as Jahagirdar et al.
Jahagirdar et al. teach a pharmaceutical composition comprising rifaximin with at least one or two entities wherein one entity is an immediate release (see the abstract). Note page 2, line 28 teaches the composition used to increase patient compliance to the treatment of hepatic encephalopathy (a complication of liver disease), also page 39, claim 19. Note page 10, lines 12-16 teaches the solubilizing agent, also known as dissolution enhancer such as surfactants and cyclodextrins. Note page 11, lines 1-2 teaches the pharmaceutically acceptable excipients include by are not limited to binders, diluents, lubricants, glidants, surface-active agents (also page 38, claim 9). Note page 11, lines 7-14 teaches the binders such as microcrystalline cellulose, and inert carrier matrix such as hydrophilic polymers such as HPMC and povidone. Note page 11, lines 16-19 teaches the fillers; lines 21-23 teaches the lubricants; and lines 25-28 teaches the glidants. Note page 12, lines 9-10 the composition is formulated into tablets. Note page 39, claim 16 teaches the dosage amount of rifaximin with a range of 20 to 2400 mg (40 mg of the present application’s dosage amount is within the range).
Clearly, the cited reference teaches a pharmaceutical composition comprising 40 mg of rifaximin and an inert carrier matrix such as hydrophilic polymers (HPMC and povidone) in an immediate-release tablet to treat hepatic encephalopathy; therefore, applicants’ instant method is unpatentable.
Note treatment can provide prevention because treating existing conditions halts progression and complication, improving long-term health and preventing further spread or severity. Treatment effectively prevents the worsening, recurrence, or spread of the complication, making to a critical part of overall health management.
Claims 36 and 38-41 are not allowed.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 36 and 38-41 are rejected under 35 U.S.C. 103 as being unpatentable over AU 2016203925 A1, hereby known as Jahagirdar et al. in view of Bajaj, “Review article: potential mechanisms of action of rifaximin in the management of hepatic encephalopathy and other complications of cirrhosis”, Alimentary Pharmacology & Therapeutics, Vol. 43, No. Supplement 1, pages 11-26 (2016).
Jahagirdar et al. were discussed above supra a pharmaceutical composition comprising rifaximin with at least one or two entities wherein one entity is an immediate release (see the abstract). Note page 2, line 28 teaches the composition used to increase patient compliance to the treatment of hepatic encephalopathy (a complication of liver disease), also page 39, claim 19. The references also taught one or more ingredients selected from the group consisting of a dissolution enhancer, a filler, a glidant, and a lubricant. Note the immediate release composition is formulated into tablets and the active agent, rifaximin’s dosage amount taught on page 39, claim 16 teaches the dosage amount of rifaximin with a range of 20 to 2400 mg (40 mg of the present application’s dosage amount is within the range).
The instant invention differs from the cited reference in that the cited reference does not teach rifaximin prevents other complications of liver disease in a subject having liver cirrhosis. However, the secondary reference, Bjaj, teaches on page 12, second column, first paragraph, teaches prophylactic therapy is recommended in patients who have had a previous episode of hepatic encephalopathy (HE). Note page 12, second column, third paragraph teaches the role of rifaximin in the management of hepatic encephalopathy and other complications of cirrhosis. Also note page 23, under FUTURE DIRECTIONS, lines 6-13, clearly teaches a phrase 2, dose-ranging study is underway to assess a new formulation (soluble solid dispersion) for the prevention of complications of liver cirrhosis, including efficacy in reducing the rates of hospitalization attributed to complications of liver disease, all-cause mortality rates and incidences of overt hepatic encephalopathy (H), spontaneous bacterial peritonitis (SBP), variceal bleeding and hepatorenal syndrome (HRS).
Claims 36 and 38-41 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
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, Jeff Lundgren can be reached at 571-272-5541. 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.
KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/Primary Examiner, Art Unit 1629