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 .
Priority
This application was filed 04/18/2024 and claims foreign priority to India 20231028283 (04/1882023). Claim 19 was canceled in paper dated 09/24/2026. Claims 1-18 and 20-21 are before the Examiner.
Claim Rejections - 35 USC § 112
The rejection of claim 8 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, as stated in paper dated 06/26/2026 has been withdrawn in view of the changes and arguments in paper date 09/24/2026.
The rejection of claims 4 and 5 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends, as stated in paper dated 06/26/2024 has been withdrawn in view of the changes and arguments in paper dated 09/24/2026.
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)(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.
The rejection of claims 1-18 and 20-21 under 35 U.S.C. 102(a)(2) as being anticipated by US Pat 11690840, is maintained now in view of US Patent 7968119 (Farrell) and Ruan. As previously stated, ‘840 teaches pharmaceutical resinate compositions for oral administration to treat pain (C2l13) with a compound which has been complexed to an exchange resin, a binder, a matrix material (C2l24). Methylnaltrexone (C13l12) in a composition (C13l24) with an ion exchange resin (C13L56). Stearic acid, glucose, bentonites, carnauba wax stearyl and other lubricants and excipients (C14 l4-33). Suitable disintegrants are taught C14 l65 – C15 l13). Suitable bulking agents are taught (C15 l14-44). Magnesium stearate is taught (C16 l23). The full composition is discussed C18 l6-21. Further support can be seen in the claims of the ‘840 patent. Farrell teaches an immediate release composition of methylnaltrexone (see abstract, paragraph 24 and Example 1 tale 1 which shows a composition of methylnaltrexone of 50 mg on up to 150mg among other concentrations). Further, Ruan teaches in the first paragraph a treatment for opioid-induced constipation (OIC) by administering an immediate-release methylnaltrexone (MNtX-IR). This fully anticipates the instant claims.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D MARGARET M SEAMAN whose telephone number is (571)272-0694. The examiner can normally be reached M-F 8am-4pm Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D MARGARET M SEAMAN/Primary Examiner, Art Unit 1625
