DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/22/2026 has been entered.
Previous Rejections
Applicant’s arguments, filed 04/22/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112 –
Indefiniteness and Lack of Antecedent Basis
Claims 1, 3-5, 7-8, 12, 16, 18-19 and 30 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.
Claims 1, 12 and 30 are confusing, and require amendment. The claims recite “consisting of” language, and are further limited to “two active agents only”. The first active agent paragraph currently recites “comprising one or more”. However, this cannot be, since the composition comprises only two active agents, and the other has to be a lipid. Therefore, the Examiner recommends amending that paragraph to “a first active agent selected from the group consisting of…”. Furthermore, the phase “or any combinations thereof” will have to be deleted.
Likewise, the second active agent paragraph currently recites “comprising one or more lipids….”. Since the lipid is an active agent, the Examiner recommends amendment reciting “a second active agent comprising one lipid administered…..wherein the one lipid is selected from the group consisting of…
Additionally, the word “phospholipid” is redundant at the penultimate line of the second active agent paragraph, and will need to be deleted.
The claim 12 interpretation follows the logic of claim 1.
Additionally, claim 12 recites the limitation "pharmacologically active agents" in line eight. There is insufficient antecedent basis for this limitation in the claim.
Further regarding claim 12, the word “phospholipid” is repeated at line five, and the word requires deletion; and, at the last line of the first active agent paragraph, the phrase “or any combinations thereof” requires deletion.
The claim 30 interpretation follows the logic of claim 1. Additionally, the phrases “or any combinations thereof” and “one or more pharmacologically active agents” requires deletion.
Claim Rejections - 35 USC § 112 –
Indefiniteness, Not further Limiting
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected 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.
Claim 5 does not further limit claim 1, from which it depends. Claim 1 limits the composition to two active agents only, inclusive of the lipid. The Examiner notes that claim 5 recites inducing drugs, which includes the drugs that induce the long QT syndrome recited in claim 1. Therefore, claim 5 broadens the claim 1 composition to three active agents, and is therefore, not further limiting.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612
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