DETAILED ACTION
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 .
Status of Claims
Claims 1-3, 5, 14-16, 21-23, 25, 29-31, 33-38, 41-44 are pending and under examination in this office action.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed November 1, 2024. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
Claim Rejections - 35 USC § 103
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) 1-3, 5, 14-16, 29 and 41-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pimentel et al. (WO 2020/191076 From submitted IDS) in view of Kogawa et al. (European Chem Bull (2017), 6(8), 359-364.
Pimentel teaches with regards to instant claim 1 a rifaximin in combination with a mucolytic agent wherein the mucolytic agent is NAC (see 0012-0013) in a form of a tablet, capsule ore sugar coated tablets (see 0086) wherein the rifamycin and the mucolytic agent are individually comprising an enteric coating (see 140 or can be combined in a tablet capsule (see 140-1.42, as required by instant claims 1-2).
With regards to instant claim 3, Pimental teaches the dosage for rifaximin can range from 25, 50, 75 t0 175 mg (see 0019, as required by instant claim 3, 5, 41-42) and NAC from 500-700 mg (as required by instant claims 9, 14 and 43, see 0020, 0037). With regards to instant claim 15, the formulation comprises one or more excipients in a solid form (see 0038) as a tablet (see 0061) and teaches the formulation maybe in the form of granules (interpreted as pellets as required by instant claim 29 in part). The reference did not per-se teach which drug therefore it is reasonable that the NAC is in the form of a pellet.
Although, Pimentel did not per-se teach the formulation of rifaximin the first and NAC the second are within a shell nonetheless teaches that the formulation can be in a capsule which is a shell absent factual evidence to the contrary. Additionally, it teaches that the formulation comprises polymers allowing controlled release (see 0086) therefore it is reasonable that these formulations can be combined to form a tablet as taught. As to the dosages, Pimentel did teach ranges, and it is within the purview of the skilled artisan through experimentation to determine the exact dosage to treat the specific disorder. The dosage amount recited by the claims overlap in scope and therefore one of ordinary skill in the art would have arrived at the claimed dosages with reasonable expectation of success. With regards to instant claim 44 NAC will increase the dissolution of rifaximin as the property of the compound cannot be stripped away. As stated in the MPEP 2112.01 "products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) ,
“Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical
processes, a prima facie case of either anticipation or obviousness has been established”.
In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO
shows a sound basis for believing that the products of the applicant and the prior art are
the same, the applicant has the burden of showing that they are not."
Kogawa teaches that solubility of rifaximin in 0.1 hydrochloric acid is undissolvable (see table 2, as required by instant claim 25
It would have been obvious to one of ordinary skill in the art to have formulated a composition/formulation comprising rifaximin in a shell i.e., capsule with both active agents which can be separately or combine to a single tablet (see 0022) with a polymer. Where MPEP 2143 states "when there is motivation to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense” to explore/search for a polymer that will not dissolve with a pH between 1.5-2.5. Therefore the skilled artisan would have had reason to try these methods with the reasonable expectation that at least one would be successful.
Claim(s) 30-31, 33-35, 37-38, is/are rejected under 35 U.S.C. 103 as being unpatentable over Pimentel et al. (WO 2020/191076).
Pimentel is applied here as it relates to claim 1 above.
Pimentel teaches with regards to instant claim 30 a rifaximin in combination with a mucolytic agent wherein the mucolytic agent is NAC (see 0012-0013) for the treatment of irritable bowel movement (see abstract as required by instant claim 30) wherein the irritable bowel movement is IBS-d (see 0011, as required by instant claim 31) and small intestinal bacterial overgrowth (as required by instant claim 33, see abstract), once the formulation is administered it will intrinsically decrease E.Coli load, klebsiella load and improve stool consistency of the small bowel (as required by instant claims 33-34 and 37 , see 0009) and duodenum (see 0107, as required by instant claim 35) additionally teaches that the formulation is administered one or more doses per day for several days e.g. 7 days to 10 days (see 0049 as required by instant claim 38).
It would have been obvious to one of ordinary skills in the art to have combined the teachings of the formulation taught by Pimentel by incorporating the recited prior art to result in the formulation of the tablet for treating IBS with a reasonable expectation of success. Therefore the claims would have been prima facie obvious at the time of filing.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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, Robert A. Wax can be reached at 571-272-0623. 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.
/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 8/28/26
Prosecution Insights