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 .
Amendments & Claim Status
The amendments to the claims filed 03 June 2026 is acknowledged and entered.
Claims 1-9 and 16-21 are pending.
Claims 1, 3-5, 7-9 are amended.
Claims 16-21 are newly added.
Claims 10-15 are cancelled.
Response to Arguments
Applicant arguments, filed 03 June 2026, with respect to the objection to the Abstract and the rejections under 112(b), 112(d), 102(a)(1), and 103 have been fully considered.
With respect to the objection to the Abstract due to informalities, Applicant’s arguments have been fully considered and are persuasive. Amendments moot the objection, as Applicant has amended the Abstract to remove legal phraseology.
The objection to the Abstract of 12 May 2026 have been withdrawn.
With respect to the rejection of claims 8-9 under 112(b) as being indefinite, Applicant’s arguments have been fully considered and are persuasive. Amendments moot the rejections.
The rejections of claims 8-9 under 112(b) of 12 May 2026 have been withdrawn.
With respect to the rejection of claim 5 under 112(d) as being of improper dependent form, Applicant’s arguments have been fully considered and are persuasive. Amendments moot the rejection.
The rejection of claim 5 under 112(d) of 12 May 2026 has been withdrawn.
With respect to the rejection of claims 1-6 under 102(a)(1) as being anticipated by Thor (WO 0117521 A1), Applicant’s arguments have been fully considered and are persuasive. Amendments moot the rejection as Thor no longer teaches each and each and every element of the instantly claimed invention. Note the claims have been amended and therefore require new grounds of rejection. Accordingly, the previous rejection under 102(a)(1) is mooted by the amendments and is withdrawn. The responses herein are with respect to Applicant’s arguments in view of the amendments and are intended to clarify the record and support the new grounds of rejection.
Regarding Thor (Remarks, p. 7, A), Applicant argues Thor fails to disclose about 75-85 wt.% microcrystalline cellulose (MCC) based on the total weight of the composition (Remarks, p. 7), instead Thor only discloses 45.% MCC (Thor, p. 27, Table 2). Additionally, Applicant argues Thor’s formulations contain multiple disintegrants (i.e., MCC and croscarmellose) and lower MCC amounts, like 45.% MCC, fail to exhibit dual bulk-filling and disintegrating functionality (Remarks, p. 8).
Applicant is correct in stating Thor fails to explicitly disclose about 75-85 wt.% MCC. Claim 1 uses the open-ended “comprising” and requires an excipient and, as such, could potentially include additional disintegrants, like croscarmellose. Referring to paragraph [0049] in the Specification, Applicant indicates MCC negates the need for a separate disintegrant. Examiner believes Applicant intended to cite paragraphs [0054]-[0055], as paragraph [0049] does not mention MCC. However, whether Thor explicitly recognizes MCC’s disintegrant functionality is irrelevant, since MCC’s disintegrant functionality had been recognized in the art, as evidenced by Saigal (Saigal et al., “Microcrystalline Cellulose as a Versatile Excipient in Drug Research” J Young Pharm 2009; 1:6-12). Saigal indicates MCC can be used as a bulking agent and/or disintegrant as well as in immediate release and/or sustained release dosage forms (p. 6, Abstract).
Regarding Thor (Remarks, p. 8, B), Applicant argues amended claim 1 recites a rapidly disintegrating immediate release hard-shell capsule comprising vegetarian hydroxypropyl methylcellulose (HPMC) having a dissolution rate faster than gelatin, which Thor fails to disclose. Furthermore, Applicant argues Thor only uses gelatin capsules and discloses HPMC as a controlled-release component in polymer matrices, gels, and permeable membranes to provide slow or controlled-release (Thor, p. 16. Lines 15-25), which Applicant alleges teaches away from the instantly claimed rapidly disintegrating HPMC capsule.
Applicant is correct in stating Thor discloses gelatin capsules, not vegetarian HPMC capsules, and in stating Thor discloses hydropropylmethyl cellulose as being used in preparing slow or controlled-release compositions (Thor, p. 16, Lines 15-25). However, Thor’s disclosure does not constitute teaching away from the instantly claimed HPMC capsules as Thor merely discloses HPMC as one ingredient which can be used in modulating the composition’s release profile and Thor does not expressly discourage or criticize using HPMC in an immediate release composition. Phrased differently, just because Thor specifically provides examples using gelatin capsules and indicates HPMC may be used in controlled-release compositions, does not constitute teaching away from using HPMC in immediate release compositions. See MPEP 2143.01(I).
Regarding Thor (Remarks, p. 9, C), Applicant argues amended claim 1 recites the composition is formulated for immediate release upon oral administration, which Thor teaches away from because (1) Thor discloses controlled-release formulations, (2) Thor’s discussion of rapidly disintegrating pharmaceutical dosage forms is limited to sublingual and buccal administration for patients who experience difficulty swallowing, and (3) Thor’s preferred dosage forms are conventional tablets and capsules, not immediate-release formulations.
As discussed above, Thor’s disclosure does not constitute teaching away from immediate release formulations. Furthermore, Thor states, “…it is understood that the compounds of the present invention may be administered as rapidly disintegrating or dissolving pharmaceutical dosage forms which are readily prepared by one of ordinary skill in the art. Such formulations are useful, for example, for human patients who have difficulty swallowing conventional tablets or capsules, and are also useful for the sublingual and buccal administration of drugs.” (Thor, p. 17, Lines 22-27). Thus, Thor discloses patients who experience difficulty swallowing as an example of a population which may receive additional benefit from such a rapid release dosage form, but Thor does not limit administration to only this population or to only sublingual or buccal administration routes.
With respect to the rejection of claims 7-9 under 103 as being unpatentable over Thor (WO 0117521 A1) in view of Sherman (US 6403120 B1), Applicant’s arguments have been fully considered and are persuasive. Note the claims have been amended and therefore require new grounds of rejection. Accordingly, the previous rejection under 35 USC 103 is mooted by the amendments and is withdrawn. The responses herein are with respect to Applicant’s arguments in view of the amendments and are intended to clarify the record and support the new grounds of rejection.
Applicant argues claim 7 has been amended, now reciting, “…wherein the rapidly disintegrating immediate release hard-shell capsule comprises vegetarian hydroxypropyl methylcellulose (HPMC) having a dissolution rate faster than gelatin.”
Applicant is correct in stating neither Thor nor Sherman explicitly discloses HPMC capsules having a dissolution rate faster than gelatin. Accordingly, additional prior art, Richardson (Richardson et al. (2019, July 18). Capsules: Using Next-Generation HPMC Polymers as an Alternative to Gelatin for Hard Capsules. Tablets & Capsules. https://www.tabletscapsules.com/3641-Technical-Articles/588363-Capsules-Using-Next-Generation-HPMC-Polymers-as-an-Alternative-to-Gelatin-for-Hard-Capsules/), which teaches next-generation HPMC capsules having a dissolution profile similar to gelatin capsules, has been added to the new 103 rejection outlined below.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7, 9, 16-18, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Thor (WO 0117521 A1) in view of Sherman (US 6403120 B1) and Richardson (Richardson et al. (2019, July 18). Capsules: Using Next-Generation HPMC Polymers as an Alternative to Gelatin for Hard Capsules. Tablets & Capsules. https://www.tabletscapsules.com/3641-Technical-Articles/588363-Capsules-Using-Next-Generation-HPMC-Polymers-as-an-Alternative-to-Gelatin-for-Hard-Capsules/) as evidenced by Saigal (Saigal et al., “Microcrystalline Cellulose as a Versatile Excipient in Drug Research” J Young Pharm 2009; 1:6-12).
Regarding claims 1-9, 16-18, and 20-21, 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).
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).
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 explicitly teach a single dose HPMC capsule comprising 15-25 wt.% and 75-85 wt.% microcrystalline cellulose.
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 explicitly teach dapoxetine or HPMC capsules..
Richardson teaches new HPMC capsules, which lack secondary gelling agents, are comparable to gelatin capsules and may be used in preparing immediate release formulations (¶ 5-6). Richardson states gelatin capsules can crosslink, which causes the capsule’s contents to be released much more slowly, and this can have a negative impact on drug development (Dissolution and crosslinking performance, ¶ 4). Thus, HPMC capsules, which lack crosslinking activity, can be advantageous over gelatin capsules.
Richardson does not explicitly teach pharmaceutical compositions.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Thor would have found it prima facie obvious to prepare a loose dry powder pharmaceutical composition comprising dapoxetine, microcrystalline cellulose, and an excipient contained in an immediate release HPMC capsule based on the teachings of Sherman and Richardson because Thor discloses an composition containing 10 wt.% dapoxetine, Sherman discloses a composition containing about 6-40% of an active ingredient and about 50-95% microcrystalline cellulose, and Richardson suggests HPMC capsules can be preferable over gelatin capsules. 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)). Additionally, as evidenced by Saigal, the ability of microcrystalline cellulose to function as a bulking agent and/or disintegrant, among other roles, had been recognized in the art as well as its utility in immediate release and sustained release dosage forms (p. 6, Abstract; p. 7, Col. 1, Filler). Saigal presents various microcrystalline cellulose grades in the Avicel product range, including Avicel PH-105, which has a nominal particle size of 20 microns and exhibits superior compactibility compared to other grades (p. 10, Table 1). 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. Thus, a PHOSITA would have had a reasonable expectation of success in preparing a composition containing dapoxetine and microcrystalline cellulose, since Thor and Sherman disclose similar compositions, and packaging said composition in a HPMC capsule, since Richardson indicates HPMC capsules can display improved or comparable pharmaceutical characteristics compared to gelatin capsules.
Note claim 6 recites the transition phrase “consisting essentially of” and the formulation in Thor includes excipients - excipients are inactive ingredients and therefore would not materially affect the basic and novel characteristics of the claimed invention.
Regarding claim 8, the laser-perforation of the capsule remains optional and is therefore not required.
Claims 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Thor (WO 0117521 A1) in view of Sherman (US 6403120 B1) and Richardson (Richardson et al. (2019, July 18). Capsules: Using Next-Generation HPMC Polymers as an Alternative to Gelatin for Hard Capsules. Tablets & Capsules. https://www.tabletscapsules.com/3641-Technical-Articles/588363-Capsules-Using-Next-Generation-HPMC-Polymers-as-an-Alternative-to-Gelatin-for-Hard-Capsules/) and further in view of Bagchi (US 20190224129 A1) as evidenced by Saigal (Saigal et al., “Microcrystalline Cellulose as a Versatile Excipient in Drug Research” J Young Pharm 2009; 1:6-12).
With respect to claims 8 and 19, the combination of Thor, Sherman, and Richardson does not explicitly teach the disintegrating immediate release hard-shell capsule is laser-perforated.
Bagchi teaches laser-perforated hard capsules, with the perforations enhancing the capsule’s dissolution (Abstract; p. 4, ¶ [0041]). Bagchi indicates the capsule can be gelatin, but gelatin may not be preferred as it is derived from animals and can cross-link, so Bagchi suggests HPMC capsules are a suitable alternative to gelatin capsules (p. 1, ¶ [0005]).
Bagchi does not explicitly teach a pharmaceutical composition comprising a selective serotonin reuptake inhibitor (SSRI).
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Thor, Sherman, and Richardson would have found it prima facie obvious to create holes in the hard-shell capsule using laser ablation based on the teachings of Bagchi because Bagchi teaches making perforations in the capsule promotes its rapid dissolution. Thus, a PHOSITA would have had a reasonable expectation of success in preparing a faster-dissolving capsule by creating perforations in said capsule based on Bagchi’s disclosure.
Conclusion
Claims 1-9 and 16-21 are rejected.
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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/B.L.B./Examiner, Art Unit 1623
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
Prosecution Insights