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 .
Claim Objections
Claim 7 is objected to because of the following informalities: Claim 7 depends from claim 7, which appears to be a typographical error. Appropriate correction is required.
Double Patenting
Claims 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/001634 (‘634).
This rejection has been withdrawn in view of the Remarks filed 08/25/2025. See page 4.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-14 are rejected 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.
This rejection has been withdrawn in view of the Amendment filed 08/25/2025.
Claim Rejections - 35 USC § 102
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 1-11 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malhotra et al. WO 2014/064409 A1.
Malhotra teaches a pharmaceutical composition comprising at least one anti-retroviral agents for the treatment of HIV-infection. See pages 1 and 7. Composition in the form of a dispersible tablet comprising an anti-retroviral agent such as dolutegravir and pharmaceutically acceptable excipient is found in pages 7-8 and 10-11 and 13-14. Excipient such as flavoring agent and sucralose is found in 14-15. Calcium is found in pages 15-16. Flavoring is found in page 17, second paragraph. Tablet core coated with a film coating is found in page 18. Coated tablet comprising dolutegravir is found in the Examples.
Response to Arguments
Applicant's arguments filed 08/25/2025 have been fully considered but they are not persuasive.
Applicant argues that the currently pending claims recite "a pharmaceutically acceptable ion" which is not addressed in the pending rejection. The present invention aims to provide formulations of dolutegravir or a pharmaceutically acceptable salt thereof which are suitable for use in the treatment of HIV infection in certain patients, in particular pediatric patients (see Specification, page 2, lines 1-3). To achieve this purpose, the invention utilizes a dispersible tablet formulation comprising dolutegravir or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable ion which is added as a solubility modifier to reduce the solubility of dolutegravir in water.
However, Applicant’s attention is called to the teaching in pages 15-16, in which calcium ion is disclosed. Page 18 teaches formulation suitable for pediatric patient comprising bulking agents that includes ion. Furthermore, calcium dibasic anhydrous is disclosed in the Examples, which further read on the calcium ion recited in the rejected claims. Therefore, for at least this reason, the 102 rejection by Malhotra is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615