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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/26/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/26/2026 has been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Status of the Claims
This action is in response to papers filed 02/26/2026 in which claims 3, 5-8, 12, 18, 20, and 22 were canceled; claims 13-15 and 21 were withdrawn; claims 1, 4, 10-11, and 15-17 were amended; and claims 24 was newly added. All the amendments have been thoroughly reviewed and entered.
Claims 1-2, 4, 9-11, 16-17, 19, 23, and 24 are under examination.
Withdrawn Rejections
The rejection of claim(s) 1-2, 4-7, 11, 16-20 and 22-23 under 35 U.S.C. 103 as being unpatentable over Liu et al (US 2016/0184246 A1) in view of Mohr et al (US 2018/0193283 A1) and Miranda et al (US 6,024,976), is withdrawn, in view of Applicant’s amendment to claim 1, which had necessitated the New Matter rejection below. Thus, Applicant’s arguments in the Remarks filed 02/26/2026 are hereby moot. However, if the new matter material was to be removed in response to the new matter rejection as set forth below, this 103 rejection may be reinstated.
The rejection of claim(s) 9 and 10 under 35 U.S.C. 103 as being unpatentable over Liu et al (US 2016/0184246 A1) in view of Mohr et al (US 2018/0193283 A1) and Miranda et al (US 6,024,976), as applied to claim 1 above, and further in view of Hille et al (US 2017/0128384 A1), is withdrawn, in view of Applicant’s amendment to claim 1, which had necessitated the New Matter rejection below. Thus, Applicant’s arguments in the Remarks filed 02/26/2026 are hereby moot. However, if the new matter material was to be removed in response to the new matter rejection as set forth below, this 103 rejection may be reinstated.
New Rejection
Necessitated by Applicant’s Claim Amendments
Claim Rejections - 35 USC § 112 – NEW MATTER
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 4, 9-11, 16-17, 19, 23, and 24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 introduces new matter as the claim recite the limitation: “the agomelatine-containing layer does not comprise a permeation enhancer. There is no support in the specification for this limitation as it pertains to the exclusion of the genus of permeation enhancer
Applicant asserted that the support for the amendments to claim 1 can be found in at least paragraph [0235] of the application as filed (specification). (Remarks filed 02/26/2026, page 7).
However, after a thorough review of said paragraph [0235], as well as, throughout the specification, there appeared to be no support for the entire genus breadth of permeation enhancer to be excluded from the agomelatine-containing layer .
It is noted that paragraph [0235] discloses:
“the agomelatine-containing layer does not comprise a permeation enhancer selected from diethylene glycol monoethyl ether, diisopropyl adipate, isopropyl myristate, isopropyl palmitate, lactic acid, dimethylethylene urea and dimethylpropylene urea.”
Thus, while Applicant has support for excluding “a permeation enhancer selected from diethylene glycol monoethyl ether, diisopropyl adipate, isopropyl myristate, isopropyl palmitate, lactic acid, dimethylethylene urea and dimethylpropylene urea” from the agomelatine-containing layer, Applicant does not have support in the specification for excluding the entire genus of “permeation enhancer” from the agomelatine-containing layer.
In fact, it is noted that the Example 6b of the specification (see paragraphs [0337] and [0349]) discloses that the agomelatine-containing layer requires isopropyl alcohol as permeation enhancer. Furthermore, all other the examples in the specification requires either ethanol or dipropylene glycol (see Examples on paragraphs [0266]-[0406] of the specification), which are penetration/permeation enhancers, per evidenced from Liu et al (US 2016/0184246 A1; cited prior art of record). See paragraphs [0008] and [0062]-[0066] of Liu.
Thus, while paragraph [0235] of the specification provided a handful of species of permeation enhancers (a permeation enhancer selected from diethylene glycol monoethyl ether, diisopropyl adipate, isopropyl myristate, isopropyl palmitate, lactic acid, dimethylethylene urea and dimethylpropylene urea) that can be excluded from the agomelatine-containing layer, this short list of species are not support for excluding the entire genus of “penetration enhancer” as claimed. This is because the genus of “permeation enhancer” includes but not limited to isopropanol (isopropyl alcohol), ethanol and dipropylene glycol, which are disclosed in the specification as one of the required components present in the agomelatine-containing layer (as discussed supra). As such, Applicant does not have possession of excluding the entire claimed genus of “permeation enhancer” from the agomelatine-containing layer
Claims 2, 4, 9-11, 16-17, 19, 23, and 24 are also rejected as they depend directly or indirectly from claim 1, thereby also containing the new matter material.
As such, the disclosure does not reasonably convey that the inventor had possession of the subject matter of claim 1 as amended at the time of filing of the instant application.
Conclusion
No claim is allowed.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613