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 .
Applicant’s amendments filed 6/3/2026 have been entered.
Claims 1, 5-19, 26-36, 42-57, 59, 62-78 are pending.
Claims 42-45, 47, 48, 50-54, 56, 57, 59 are withdrawn from further consideration as they are directed to non-elected subject matter.
Due to the amendments filed 6/3/2026, the outstanding rejections are modified.
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.
Claim(s) 1, 3-19, 26-36, 46, 49, 55, 58, 62-78 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2018/089570 (‘570) in view of US 10,806,709 (‘709), US2017/0290776 (‘776) and MOHAMMADI NEJAD et al., Turk J Pharm Sci 2017;14(2):201-206.
‘570 teaches the herein claimed epinephrine prodrug as suitable for use to treat anaphylaxis (see the abstract, also Fig. 2, and claims 1 and 22 for example). ‘570 teaches the herein claimed epinephrine prodrug as suitable to be delivered via fast dissolving film for buccal delivery (see for example [0037] – [0038], claims 2, 3, and 19).
‘570 does not expressly teach the penetration enhancer as those recited in the claims. ‘570 does not expressly teach the herein claimed ratio of the prodrug and the penetration enhancer.
‘709 teaches a method of treating anaphylaxis by administering anti-anaphylactic agents, including dipivefrin, intranasally (see the abstract, col. 9, line 20 for example). ‘709 teaches the particle size of the active as 20-50µm (see col. 16, lines 3-16). ‘709 teaches penetration or permeation enhancers being included to facilitate the absorption of the anti-anaphylactic agent in the amount of 1-30% (see col. 10, line 52 bridging col. 12, line 13). The dosage of the epinephrine in the instant invention is 0.05mg to 10mg (see claim 9). ‘709 teaches the volume intended to be administered as 100µl (see col. 26, lines 30-34). The examiner notes that the ratio between the actives and the permeation enhancing agent would meet the limitations of claims 2-7.
‘776 teaches mucosal permeation systems for delivering an adrenergic-receptor modulators such as epinephrine (see for example claims and 19). ‘776 teaches a permeation enhancer as clove oil from clove leaf, bud, and/or stem (see Fig. 11 and example 1 for example). ‘776 teaches 3% of clove oil (see for example [0178]). ‘776 teaches the matrix comprising a water soluble polymer (see for example claim 21). ‘776 also teaches the pharmaceutical dosage form includes film (see claim 23).
MOHAMMADI NEJAD et al. teaches eugenol is the main extracted constituent (70-90%) of cloves (see page 201, Introduction section).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the penetration enhancer such as eugenol, to deliver the herein claimed epinephrine prodrug through the mucosal tissue to treat anaphylaxis. It would have been obvious to one of ordinary skill in the art at the time of filing to employ the herein claimed ratio of the penetration enhancer and the epinephrine prodrug.
One of ordinary skill in the art would have been motivated to employ the penetration enhancer such as eugenol, to deliver the herein claimed epinephrine prodrug through the mucosal tissue to treat anaphylaxis. It is known that clove extract containing a large amount of eugenol. Since the penetration/permeation enhancers are known to be suitable and compatible with adrenergic modulator such as epinephrine for transmucosal administration, incorporating the extract of clove plant such as clove oil (i.e., eugenol) and the matrix of water-soluble polymer would be reasonably expected to impart beneficial effect for the epinephrine prodrug composition. Furthermore, one of ordinary skill in the art would have been motivated to employ the herein claimed ratio of the penetration enhancer and the epinephrine prodrug. The examiner notes that the penetration enhancers is taught to be 3% in amount and the anti-anaphylactic agents to be 1-30% in amount. Accordingly, ratio between the penetration enhancer/ anti-anaphylactic agents (i.e., epinephrine prodrug) meets the limitation recited in claim 1.
The herein claimed resulting effect of the administration of the epinephrine prodrug is considered inherently present in the method taught by the cited prior art.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-19, 26-36, 46, 49, 55, 58, 62-78 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627
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