DETAILED ACTION
Requirement for Restriction/Election was mailed 05 February 2026.
Applicant’s Response to Election/Restriction Requirement was received 05 February 2026 (“Response”).
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 .
Status of the Claims
The listing of claims filed 05 February 2026 has been examined. Claims 1-15 are pending. Claim 15 is amended.
Election/Restrictions
Applicant’s election of Group I (claims 1-9) without traverse in the response dated 2/5/2026 is acknowledged. The claims in Group II (Claims 10-15) are withdrawn.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains legal phraseology, specifically the term “comprise.” A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112(b)
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.
Claim 8-9 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.
Claim 8 recites the limitation "the capsule." It is unclear whether “the capsule” is shorthand language referring to the “single dose pharmaceutical capsule” recited in the preamble of claims 7-8 or the “hard-shell capsule” component recited in claim 7, upon which claim 8 depends.
Claim 9 recites the limitation "each capsule." It is unclear whether “each capsule” refers to the “single dose pharmaceutical capsule” recited in the preamble of claims 7 and 9 and/or the “hard-shell capsule” component recited in claim 7, upon which claim 9 depends. If “each capsule” refers to both options, then claim 9 may require two units of “about 15mg to about 60mg dapoxetine,” and the claim should be reviewed for consistency with the preamble (“single dose pharmaceutical capsule”).
Claim Rejections - 35 USC § 112(d)
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 is directed to: “The pharmaceutical composition of claim 1, wherein the optional excipient is . . .” The term “optional” means the subject matter may or may not be present. Thus, the scope of claim 5 is either: (i) a composition comprising and SSRI and a carrier; or (ii) the composition of (i) and an excipient.
To be a proper dependent claim under section 112(d), claim 5 must narrow the scope of claim 1. Because the term “optional” does not impose a further structural requirement to the subject matter of claim 1, it does not narrow the scope of claim 1. Accordingly, claim 5 is an improper dependent claim.
Applicant may cancel claim 5, amend the claim(s) to place claim 5 in proper dependent form, rewrite the claim 5 in independent form, or present a sufficient showing that dependent claim 5 complies with the statutory requirements. For example, Applicants may overcome this rejection by deleting “optionally,” from claim 1 (line 5) and “optional” from claim 5 (line 1).
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.
(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.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thor (WO 0117521 A1).
Thor discloses methods by which rapid-onset selective serotonin reuptake inhibitors (SSRIs) like dapoxetine may be used on an as-needed basis in treating sexual dysfunction, including premature ejaculation (p. 1, Lines 6-10; p. 7, Lines 5-10). Thor indicates the SSRI may be administered in combination with other compounds such as citalopram, dapoxetine, fluoxetine, paroxetine, and sertraline which can increase or enhance the effect of monoamines or serotonin in the subject experiencing sexual dysfunction (p. 12, Line 28 – p. 13, Line 12). Thor says tablets and capsules are the preferred oral dosage form due to the ease with which tablets and capsules may be administered to a subject (p. 16, Lines 3-5).
Regarding claims 1-4 and 6, Thor teaches an oral formulation comprising the SSRI dapoxetine, the carrier microcrystalline cellulose, and multiple excipients including pre-gelatinized starch, croscarmellose, and magnesium stearate (p. 27, Table 2). Further, Thor states dapoxetine may be sieved or blended with the other components and the resultant mixture can be placed in two-piece hard gelatin capsules (p. 27, Lines 3-9). Thor states dapoxetine may also be administered as the base compound or as a pharmaceutically acceptable salt, specifically mentioning the HCl salt (p. 7, Lines 15-18). Although claim 6 recites the transition phrase “consisting essentially of” and the formulation in Thor includes excipients, the excipients are inactive ingredients and therefore would not materially affect the basic and novel characteristics of the claimed invention.
Regarding claim 5, the excipient remains optional and is therefore not required.
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 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Thor (WO 0117521 A1) in view of Sherman (US 6403120 B1).
Regarding claim 7, Thor teaches all of the claimed elements as stated above. Furthermore, Thor discloses a 200 mg pharmaceutical composition to be contained in a hard gelatin capsule comprising 20.0 mg dapoxetine, 90.0 mg microcrystalline cellulose, as well as other excipients wherein dapoxetine is 10 wt.% and microcrystalline cellulose is 45 wt.% (p. 27, Table 2, “20 mg capsule” Column; p. 27, Lines 4-6). Altogether, all the components besides dapoxetine comprise 90 wt.%. Furthermore, Thor states, “Other doses may be prepared by altering the fill weight and, if necessary, changing the capsule size to suit” (p. 27, Lines 8-9). Additionally, Thor discloses a 450 mg pharmaceutical composition to be contained in capsules comprising 34.053 mg dapoxetine HCl and other excipients, not including microcrystalline cellulose (p. 32, Table 7, “30 mg Capsule” Column). In this composition, dapoxetine HCl is approximately 7.57 wt.%.
Thor does not teach a single dose pharmaceutical capsule wherein dapoxetine-hydrochloride comprises 15-25 wt.% and microcrystalline cellulose comprises approximately 75-85 wt.%.
Sherman teaches an extended-release pharmaceutical formulation containing venlafaxine hydrochloride, which is an antidepressant, as well as microcrystalline cellulose and hydroxypropylmethylcellulose (Col. 2, Lines 17-21; Col. 3, Lines 1-8). Sherman discloses capsule dosage forms, including gelatin capsules, may be used as an alternative to tablets when producing tablets in infeasible (Col. 1, Lines 38-53). The formulation, comprising spheroids, contains about 6-40% venlafaxine hydrochloride, about 50-95% microcrystalline cellulose, and, optionally, about 0.25-1% hydroxypropylmethylcellulose by weight (Col. 3, Lines 8-14; Claim 4). These spheroids receive a coating comprising about 80-90% ethyl cellulose and about 10-20% hydroxypropylmethylcellulose by weight (Col. 3, Lines 14-19). In other embodiments, microcrystalline cellulose comprises about 70-94% by weight (Col. 3, Lines 32-35 and 44-46). Sherman indicates the formulation is, preferably, contained in a gelatin capsule (Col. 3, Lines 60-63). Furthermore, Sherman says the venlafaxine formulation can be administered once daily, which helps to minimize the negative effects associated with multiple daily dosing of venlafaxine hydrochloride, such as nausea (Col. 2, Lines 51-65)
Sherman does not teach dapoxetine.
Prior to the filing of the instant application, a PHOSITA following the teachings of Thor and Sherman would have found it prima facie obvious to prepare a pharmaceutical composition comprising about 15-25 wt.% dapoxetine-hydrochloride and about 75-85 wt.% microcrystalline cellulose because Thor discloses an oral formulation containing 10 wt.% dapoxetine and Sherman discloses a pharmaceutical formulation containing about 6-40% of an active ingredient and about 50-95% microcrystalline cellulose. According to the instant specification, “about” encompasses the actual stated value as well as some variability, which may include ±10% (p. 4, Lines 25-28). Claim 7 recites the single dose pharmaceutical capsule may comprise “about 15 wt.% to about 25 wt.% dapoxetine-hydrochloride,” which in accordance with the instant specification includes 5-35 wt.% dapoxetine-hydrochloride. Thus, the dapoxetine amount disclosed by Thor is within this range. Furthermore, in regard to Thor, it would have been prima facie obvious to replace dapoxetine with its pharmaceutically acceptable salt, dapoxetine-hydrochloride. While Thor does not disclose a microcrystalline cellulose amount as large as about 75 wt.%, Thor does disclose pharmaceutical compositions containing dapoxetine and microcrystalline cellulose as well as other excipients and the microcrystalline cellulose range recited in instant claim 7 is encompassed by the range disclosed by Sherman. A skilled artisan could have optimized the amount of microcrystalline cellulose by routine experimentation in order to achieve the desired impact on the pharmacokinetic profile of the pharmaceutical formulation (2144.05(II)(A)). Furthermore, in a pharmaceutical composition wherein the active ingredient comprises about 15-25 wt.%, the remaining 75-85 wt.% necessarily comprises some other ingredient or multiple ingredients like pharmaceutically acceptable excipients and/or carriers, etc.
Regarding claim 8, the combination of Thor and Sherman teaches all of the claimed elements as stated above. Furthermore, Thor discloses a hard gelatin capsule (p. 27, Lines 4-6) and Sherman discloses including hydroxypropylmethylcellulose (Claims 3-12).
Prior to the filing of the instant application, a PHOSITA following the teachings of Thor and Sherman would have found it prima facie obvious to prepare a pharmaceutical formulation containing hydroxypropyl methylcellulose (HPMC) in gelatin capsules because both Thor and Sherman disclose gelatin capsules and Sherman discloses including HPMC.
Regarding claim 9, the combination of Thor and Sherman teaches all of the claimed elements as stated above. Furthermore, the capsules disclosed by Thor which include microcrystalline cellulose contain 20.0 mg dapoxetine (p. 27, Table 2, “20 mg capsule” Column) and the capsules disclosed by Thor which lack microcrystalline cellulose contain 34.053 mg dapoxetine HCl (p. 32, Table 7, “30 mg Capsule” Column).
Prior to the filing of the instant application, a PHOSITA following the teachings of Thor would have found it prima facie obvious to prepare a pharmaceutical composition containing about the claimed dapoxetine amounts because Thor had disclosed an oral formulation containing an amount within the claimed range.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANNA L BAUER whose telephone number is (571)272-5752. The examiner can normally be reached 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ADAM C MILLIGAN can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.L.B./Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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