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 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 1-14 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This rejection has been withdrawn in view of the Amendment filed 08/27/2025.
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, 6, 10, 11 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malhotra et al. WO 2015/140569 A1.
Malhotra teaches a pharmaceutical composition comprising dolutegravir in a solid oral dosage form such as tablets including disintegrating tablets, and dispersible tablets. See page 12, 2nd paragraph. The composition further comprising tablet excipients, carriers, and film coating. See pages 12-19. Treatment for HIV infection is found in page 21. The pharmaceutical composition comprising dolutegravir may further comprise abacavir and lamivudine, optionally wherein the abacavir is in the form of abacavir sulfate, wherein at least the dolutegravir is preferably in a nanosized form. See page 21, 1st paragraph.
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.
Claims 1, 3-6, 10, 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Malhotra et al. WO 2015140569 A1 (‘569), in view of McDermott et al. US 2014/0234415 A1.
Malhotra ‘569 is relied upon for the reason stated above, the ‘569 reference does not expressly teach the dispersible tablet includes a bilayer tablet.
McDermott teaches a dispersible tablet includes a bilayer tablet comprising a first layer and a second layer, wherein the layers comprise two or more different active ingredients. See Abstract and paragraph 0011. Coated tablet is found in paragraphs 0012 and 0049. Film coat to improve taste is found in paragraph 0126. Composition further comprising additives such as sweeteners is found in paragraphs 0084, 0127-0132. Method of treating HIV infection comprises administering a tablet dosage form of the invention to a HIV patient in need thereof is found in paragraph 0034.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to optimize the teaching in the Malhotra reference in view of the teaching of McDermott with the expectation to obtain a tablet dosage form useful for the treatment of HIV infection. This is because McDermott teach a tablet dosage form useful for the delivery of two or more different anti-HIV agents that is more stable, corresponding to pediatric patient population, less cracking, and improved bioavailability. As such, one of ordinary skill in the art would have been motivated to prepare a bilayer tablet in view of the teaching of McDermott to obtain a tablet composition suitable for the delivery of dolutegravir, abacavir and lamivudine for the treatment of HIV infection. This is because Malhotra teaches the desirability to combine two or more different anti-HIV agents in a tablet dosage form, and this is also because Malhotra teaches the desirability to prepare a dispersible tablet dosage form with improved solubility, stability and bioavailability useful for the delivery of multiple anti-HIV agents in combination.
Claims 1, 3-11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Malhotra et al. WO 2015140569 A1 (‘569), in view of Malhotra et al. WO 2015059466 A1 (‘466).
Malhotra ‘569 is relied upon for the reason stated above. The reference does not expressly teach a dispersible bilayer tablet comprising at least two sweeteners.
Malhotra ‘466 teaches a pharmaceutical composition for the delivery of at least one anti-HIV agent, the composition comprising a dispersible bilayer or multilayer tablet which may be film coated, sugar coated, powder coated, enteric coated, seal coated. See Abstract; Claims; and page 9, 2nd paragraph. The pharmaceutical composition further comprises excipients including sweeteners such as acesulfame, sucralose and combination thereof. See page 14.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to, by routine experimentation include sweeteners such as acesulfame and sucralose and combination thereof with the expectation to obtain a tablet useful for the delivery of two or more anti-HIV agents to a wide variety of patient populations including pediatric. This is because Malhotra ‘466 teaches the use of sweeteners such as acesulfame and sucralose in a dispersible tablet is known in the art, and this is because the Malhotra ‘569 reference teaches the desirability for using a wide variety of known tablet excipients.
Claims 1-7 and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over McDermott et al. US 2014/0234415 A1, in view of Allavena et al. (Medecine et maladies infectieuses).
This rejection has been withdrawn in view of the Amendment filed 08/27/2025.
Response to Arguments
Applicant's arguments filed 08/27/2025 have been fully considered but they are not persuasive.
Applicant argues that the Office has failed to articulate why one of ordinary skill in the art would have a reasonable expectation of success (much less a motivation to combine) formulating the claimed active ingredients of dolutegravir or a pharmaceutically acceptable salt thereof, abacavir or a pharmaceutically acceptable salt thereof, and lamivudine into the tablet formulation of McDermott (which is clearly designed for the particular active ingredients described in its specification). Due to failure to state a prima facie case, Applicant respectfully requests the pending rejection be withdrawn. The Office has provided no reasoning as to why one of skill in the art would have expected the various active ingredients and formulations cited by the Office to work together (much less any motivation to select the references and motivation to combine them). As such, the Office has failed to state a prima facie case. Applicant therefore requests that the rejection be withdrawn.
However, Applicant’s attention is called to the preamble of the claims at the time of the rejection, because the claims did not require all three active agents: dolutegravir, abacavir and lamivudine in combination in the dispersible tablet. See also the 112, second paragraph rejections in the Office Action dated 04/24/2025.
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.
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