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
Election of Species and Status of the Claims
Applicant’s election of ‘a solid composition of NAC and TUDCA’ as the single composition comprising at least two antioxidants, ‘ulcerative colitis’ as the single disease/disorder/condition, and ‘daily administration’ as the single dosage schedule, in the response filed on December 10th 2025 is acknowledged. Claims 1-5, 13-15, 17-21, 49, 51-54, and 56-57 are pending. Claims 2, 4-5, 14-15, 18, 21, 52, and 54 are withdrawn from further consideration as being directed towards nonelected species until a generic claim has been found allowable. Claims 1, 3, 13, 17, 19, 20, 49, 51, 53, 56, and 57 are examined on their merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 120 is acknowledged. Applicant has complied with all conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 based on the date of the provisional applications 63/420,221 filed on October 28th 2022 and 63/429,671 filed on December 2nd 2022.
Information Disclosure Statement
The Information Disclosure Statement filed on May 5th 2025 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Minor Informalities
Claim 19 recites “the method of any of claim 1,” in reference to a single claim. Appropriate correction is required.
Claim Objections
Claim 51 is objected to as being incomplete for its dependency on the canceled claim 50. For the purpose of examination, claim 51 will be treated as if it depends on claim 49.
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.
Claims 1, 3, 13, 19, and 49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Siddiqui (Siddiqui et al., Antioxidant Therapy with N-Acetylcysteine Plus Mesalamine Accelerates Mucosal Healing in a Rodent Model of Colitis. Dig Dis Sci 51, 698–705 (2006)).
Claims 1 and 3 are directed towards a method for treating ulcerative colitis via administration of n-acetylcysteine (NAC) and at least one more antioxidant. Siddiqui teaches the treatment of ulcerative colitis via daily rectal administration of NAC and mesalamine (Siddiqui, Abstract; Siddiqui, pg. 700, Results), anticipating claims 1 and 3.
Claim 13 limits the method of claim 1 to daily administration and is anticipated by Siddiqui, who teaches daily administration (Siddiqui, Abstract).
Claim 19 requires that, in the method of claim 1, the two antioxidants are in a single composition. Siddiqui teaches simultaneous administration of NAC and mesalamine (Siddiqui, pg. 699, Materials and Methods), anticipating claim 19.
Claim 49 is directed towards a composition comprising NAC and at least one other antioxidant. Siddiqui teaches NAC with mesalamine (Siddiqui, pg. 699, Materials and Methods), anticipating claim 49.
Claims 1, 3, 13, 19, and 49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guijarro (Guijarro et al., N-acetyl-L-cysteine combined with mesalamine in the treatment of ulcerative colitis: randomized, placebo-controlled pilot study. World J Gastroenterol. 2008 May 14;14(18):2851-7).
Claims 1 and 3 are directed towards a method for treating ulcerative colitis via administration of n-acetylcysteine (NAC) and at least one more antioxidant. Guijarro teaches the treatment of ulcerative colitis via daily oral administration of NAC and mesalamine (Guijarro, pg. 2151, Methods), anticipating claims 1 and 3.
Claim 13 limits the method of claim 1 to daily administration and is anticipated by Guijarro, who teaches daily administration (Guijarro, pg. 2151, Methods).
Claim 19 requires that, in the method of claim 1, the two antioxidants are in a single composition. Guijarro teaches solid dosage of NAC with mesalamine (Guijarro, pg. 2151, Methods), anticipating claim 19.
Claim 20 limits the composition administered in claim 19 to a solid composition. Guijarro teaches solid dosage of NAC with mesalamine (Guijarro, pg. 2151, Methods), anticipating claim 20.
Claim 49 is directed towards a composition comprising NAC and at least one other antioxidant. Guijarro teaches solid dosage of NAC with mesalamine (Guijarro, pg. 2151, Methods), anticipating claim 49.
Claim 53 is directed towards the composition of claim 49 wherein said composition is a solid composition. Guijarro teaches solid dosage of NAC with mesalamine (Guijarro, pg. 2151, Methods), anticipating claim 49.
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.
Claims 17, 51, and 56-57 are rejected under 35 U.S.C. 103 as being unpatentable over Guijarro in view of Laukens (Laukens et al., Tauroursodeoxycholic acid inhibits experimental colitis by preventing early intestinal epithelial cell death. Lab Invest 94, 1419–1430 (2014)).
Claim 17 limits the method of claim 1 to wherein one of the at least two antioxidants is tauroursodeoxycholic acid (TUDCA). For the teachings of Guijarro as they relate to claim 1, see the above 102 rejection over Guijarro. Regarding the administration of TUDCA, Laukens teaches the treatment of ulcerative colitis via administration of TUDCA (Laukens, pg. 1423). One of ordinary skill in the art would therefore have a reasonable expectation of substituting the mesalamine in Guijarro’s method for TUDCA, and claim 17 is therefore prima facie obvious.
Claim 51 limits the composition of claim 49 to wherein one of the at least two antioxidants is TUDCA. For the teachings of Guijarro as they relate to claim 49, see the above 102 rejection over Guijarro. Regarding the administration of TUDCA, Laukens teaches the treatment of ulcerative colitis via administration of TUDCA (Laukens, pg. 1423). One of ordinary skill in the art would therefore have a reasonable expectation of substituting the mesalamine in Guijarro’s composition for TUDCA, and claim 17 is therefore prima facie obvious.
Claim 56 is directed towards the composition of claim 49 comprising at least NAC and TUDCA in a solid form. Claim 56 is prima facie obvious for the same reasons as claim 51.
Claim 57 is directed towards the method of claim 1, wherein NAC and TUDCA are administered daily in a single solid form. Claim 57 is prima facie obvious for the same reasons as claim 17.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629