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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/20/2026 has been entered.
Information Disclosure Statement
Non-patent literature reference 12 in the information disclosure statement filed 2/23/2026 corresponding to “Cosmetic Ingredient Information Online” fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
A non-patent literature reference filed 2/23/2026 corresponding to a portion of an English translation of Japanese Patent Application No. 2022-518665 has been provided but is not listed in either information disclosure statement filed 2/23/2026.
Status of the Claims
Claims 1-24, 26, 32, 37-40, and 42-44 are cancelled. Claims 25, 27-31, 33-36, 41, and 45-47 are pending and under current examination.
Withdrawn Claim Rejections
All rejections not reiterated have been withdrawn.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.
Claims 25, 27-31, 33-36, 41, and 45-47 are rejected under 35 U.S.C. 103 as being unpatentable over Kabir (WO 2018/064472, published 4/5/2018, of record) in view of Randall (U.S. Patent Application No. 2015/0164866, publication year: 2015, of record).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 25, Kabir teaches an immediate release soluble dispersion tablet comprising 40mg rifaximin administered to patients once per day for 24 weeks [0080]. Because the treatment embraced by Kabir is identical to the treatment of the instant claim 25, the concentration of secondary fecal bile acids must also increase by an amount within the same range as the instant claim 25. See MPEP 2112 (III).
Regarding claim 27, Kabir teaches a soluble dispersion tablet comprising rifaximin and HPMC-AS [0075 Table 3].
Regarding claim 28, Kabir teaches an immediate release tablet containing 40mg rifaximin and 40mg HPMC-AS [0075 Table 3].
Regarding claims 29 and 30, Kabir teaches a soluble dispersion tablet comprising 40mg rifaximin administered to patients once per day for 24 weeks [0080]. Because the treatment embraced by Kabir is identical to the treatment of the instant claim 25, the concentration of secondary fecal bile acids must also increase by an amount within the same range as the instant claims 29 and 30 as a result of the treatment embraced by Kabir. See MPEP 2112 (III).
Regarding claim 31, Kabir teaches an immediate release soluble dispersion tablet comprising 40mg rifaximin administered to patients once per day for 24 weeks [0080]. Because the treatment embraced by Kabir is identical to the treatment of the instant claim 31, the increase in secondary fecal bile acids must also occur as a result of the treatment embraced by Kabir within the same time frame embraced by the instant claim 31. See MPEP 2112 (III).
Regarding claim 33, Kabir teaches a soluble dispersion tablet comprising rifaximin and HPMC-AS [0075 Table 3].
Regarding claim 34, Kabir teaches an immediate release tablet comprising 40mg rifaximin and 40mg HPMC-AS [0075 Table 3].
Regarding claims 35 and 36, Kabir teaches a soluble dispersion tablet comprising 40mg rifaximin administered to patients once per day for 24 weeks [0080]. Because the treatment embraced by Kabir is identical to the treatment of the instant claim 31, the concentration of secondary fecal bile acids must also increase by an amount within the same range as the instant claims 35 and 36 as a result of the treatment embraced by Kabir. See MPEP 2112 (III).
Regarding claims 41 and 45, Kabir teaches a soluble dispersion tablet comprising 40mg rifaximin administered to patients once per day for 24 weeks [0080].
Regarding claims 46 and 47, Kabir teaches the relevant limitations of claims 25 and 31 above.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 25, 31, 46, and 47, Kabir does not teach the treatment of obesity or alcoholism with the disclosed rifaximin composition. However, this deficiency is cured by Randall.
Randall teaches a method of treating obesity comprising administration of a composition comprising rifaximin [0004]. Rifaximin may be administered in once daily doses of about 40 mg [0033 and 0036]. The rifaximin may be administered as a soluble solid dispersion [0034] for 1 week to about 52 weeks [0035].
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 25 and 31, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing that the composition disclosed by Kabir could be used to treat obesity. One would have understood in view of Randall that rifaximin is suitable for the treatment of patients with obesity using an identical treatment regimen [0004 and 0033]. The artisan of ordinary skill would have had reasonable expectation of success because Randall teaches that rifaximin may be used in a method of reducing weight and treating obesity [0004]. See MPEP 2144.07.
Response to Arguments
Applicant's arguments filed 2/20/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to the rejection under 35 U.S.C. 103 over Kabir in view of Vlachogiannakos and evidenced by Acosta and Burrows have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
On page 7, Applicant argues that Randall discloses the administration of substantially more rifaximin to a subject with different administration frequence, therefore one of skill in the art would not have any expectation that lowering the daily dosage of rifaximin from 1100mg a day to 40 mg a day would be effective in treating obesity in a subject. This is not found persuasive. In response, the Examiner respectfully draws attention to MPEP 2123 (I) which states: “a reference may be relied upon for all that it would have reasonable suggested to one having ordinary skill in the art, including nonpreferred embodiments”. While Randall does teach an example method of treating obesity comprising 550mg of rifaximin twice a day, it also teaches that 40mg of rifaximin may be administered once per day to treat obesity [0033 and 0036]. The existence of alternative methods of treatment is not dispositive of non-obviousness. Therefore, because the broad disclosure of Randall teaches a method of treating obesity comprising once daily administration of 40mg of rifaximin, the argument is not persuasive and the rejection is maintained.
On pages 6 and 7, Applicant argues that the administration of an immediate release soluble solid dispersion tablet comprising about 40mg of rifaximin once daily unexpectedly has an impact on gut microbial function by increasing the total and secondary fecal bile acid concentrations in the subject. This is not found persuasive. In response, please refer to MPEP 716.02 (b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
Differences in results are in fact unexpected and unobvious: The evidence of unexpected properties amounts to an increase in total and secondary fecal bile acid concentrations in patients treated once daily with 40mg of rifaximin. Randall teaches a method of treating obesity comprising once daily administration of 40mg of rifaximin [0033 and 0036] for 1 week to about 52 weeks [0035] and Kabir teaches an immediate release soluble dispersion tablet comprising 40mg rifaximin administered to patients once per day for 24 weeks [0080]. Please refer to MPEP 2112 (III) which states: “where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103”. Because the treatment embraced by Kabir is identical to the treatment of the instant claims 31 and, as described in the rejection statement above, it would have been obvious to use the treatment of Kabir in a method of treating obesity, the concentration of secondary fecal bile acids must also increase by an amount within the same range as the instant claims as a result of the treatment embraced by Kabir in view of Randall. Therefore, the differences in results are not unexpected or unobvious.
Differences are of both practical and statistical significance: The evidence of unexpected properties amounts to a statistically significant increase in total and secondary fecal bile acid concentrations in patients treated once daily with 40mg of rifaximin. Therefore, the differences are of practical and statistical significance.
Evidence of unexpected properties must be in commensurate scope with the claims: The evidence of unexpected properties amount to an increase in total and secondary fecal bile acid concentrations in a method of treating adults with cirrhosis and ascites. The evidence of unexpected properties does not pertain to an increase in total and secondary fecal file acid concentrations in a method of treating obesity. Therefore, the evidence of unexpected properties is not in commensurate scope with the claims.
Additionally, no side-by-side comparison to the closest prior art is provided to establish unexpectedly superior performance. There is no nexus between the purportedly unexpected property and the differences between the instant invention, as claimed, and the closest prior art. Thus, the Applicant’s argument is not persuasive and the rejection is maintained.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH ANNE MEYERS whose telephone number is (571)272-2271. The examiner can normally be reached Monday-Friday 8am-5pm ET.
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, Ali Soroush can be reached at 571-272-9925. 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.
ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614