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 .
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.
Claim(s) 1-7, and 13-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication 2015/0144127 Ekman et al (Ekman hereinafter).
Regarding claim 1, Ekman teaches a nasal drug delivery device, comprising a tip (at 12a) configured to be positioned at a nose of a patient (paragraph 21), an opening (12b) in the tip, a propellant chamber (attached to 12c, see paragraph 55) containing a propellant (e.g. gas), a drug chamber (22) containing a drug therein (paragraph 44), a stopper (20) positioned between the propellant chamber (at 12c) and the drug chamber ( see Figs. 1A-1C), and an actuator(see paragraph 51, “the user may actuate a power source”) configured to be actuated to cause the propellant to move the stopper and thereby propel the drug out of the opening (at 24).
Regarding claim 2, Ekman teaches a body (12) containing the propellant chamber and drug chamber in a cavity thereof.
Regarding claim 3, Ekman teaches a body (12) with an internal cavity having the drug chamber (22) and stopper (20) therein, a container (canister, see paragraph 61) defining the propellant chamber, and a tubular conduit (extending from opening 12c) to the container from the rest of the body.
Regarding claim 4, Ekman teaches a seal member (18) configured to be broken by the propelled drug (see Fig. 1B).
Regarding claim 5, Ekman teaches that the propellant chamber, drug chamber, tip and stopper are all longitudinally aligned (see e.g. Fig. 1A wherein the longitudinal axis is vertical).
Regarding claim 6, depending on the longitudinal axis chosen, the propellant chamber, drug chamber, and stopper are or are not aligned with each other.
Regarding claim 7, Ekman teaches a gas (paragraph 55).
Regarding claim 13, Ekman teaches actuating an actuator (paragraph 51) and thereby causing a propellant (paragraph 55) to propel a stopper (20) to cause a drug (paragraph 44) to spray out a tip opening (12b) disposed in the nose of the patient (paragraph 21).
Regarding claim 14, Ekman teaches a body (12) with an internal cavity having the drug chamber (22) and stopper (20) therein, a container (canister, see paragraph 61) defining the propellant chamber, and a tubular conduit (extending from opening 12c) to the container from the rest of the body.
Regarding claim 15, Ekman teaches breaking of a seal member (18, see Fig. 1B).
Regarding claim 16, Ekman teaches a gas (paragraph 55).
Claim(s) 20-23, 26-29, 32-35 and 38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication 2016/0101245 to Hoekman et al. (Hoekman).
Regarding claim 20, Hoekman teaches a nasal drug delivery system comprising a drug holder (330), and a nasal drug delivery device (310) which comprises a tip (335) with an opening (paragraph 155, “hollow portion for delivery of at least the compound contained in the unit dose container”), a tubular coupling mechanism (315) configured to releasably couple to the drug holder, a propellant chamber (355) configured to contain propellant therein, a pumping chamber (385) in fluid communication with the opening and the coupling mechanism, an actuator (actuating 311, see e.g. paragraph 162, “actuation” which requires some form of actuator) and a pumping mechanism (311), wherein the actuation is configured to cause the propellant to come into fluid communication with the pumping chamber (paragraph 162).
Regarding claim 32, Hoekman teaches a drug delivery device and method comprising coupling a drug holder (330) to a tubular coupling mechanism (315) of a drug delivery device (310), after coupling, actuating (firing, see e.g. paragraph 185) an actuator to cause a propellant (HFA) to propel the drug out of a tip (320) that is positioned in a nose of the patient (paragraph 92), including pumping the pumping device (311) after coupling the drug holder (330) and actuating the actuator to cause the pumping. The examiner notes that while both steps i) and ii) are required to take place after the coupling of the drug holder, the order of steps i) and ii) is not specified and therefore may take place in either order.
Regarding claims 21 and 33, Hoekman teaches a gas (HFA).
Regarding claims 22, 23, 34 and 35, Hoekman teaches a blow-fill-seal vial (330, see e.g. paragraphs 25, 150).
Regarding claim 26 and 38, as shown in Figs. 26 and 27, Hoekman teaches breaking a seal member (skin of 330).
Regarding claim 27, Hoekman teaches a seal member (left end of 330 in Fig. 26) of the drug holder which is configured to be broken by the coupling mechanism (315) in response to coupling therewith (as illustrated in Fig. 27).
Regarding claim 28, Hoekman teaches a pointed tip (345).
Regarding claim 29, Hoekman teaches a sharp, circular edge (345).
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) 11-12, 19 and 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ekman in view of US Pre-Grant Publication 2018/0193332 to Loughlin et al. (Loughlin).
Regarding claims 11-12, Ekman teaches the apparatus of claim 1 as discussed above, but does not teach any of the particular drugs enumerated in these claims. Loughlin teaches the use of naloxone in emergency treatment of opioid overdose (paragraphs 3 and 12). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide naloxone as taught by Loughlin in the delivery device of Ekman in order to prevent harm caused by opioid overdose.
Regarding claims 19 and 30-31, the same analysis regarding naloxone discussed above with respect to claims 11-12 applies to these claims as well.
Claim(s) 25-26 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoekman in view of US Pre-Grant Publication 2018/0193332 to Loughlin et al. (Loughlin).
Regarding claims 25-26 and 37, Hoekman teaches the limitations of claim 20 (and the new limitations of claim 26) as discussed above, but does not teach the use of a swirl chamber. Loughlin teaches that nasal medication delivery devices may be provided with a swirl chamber. Those of ordinary skill in the art will appreciate that such a chamber has benefits such as promoting mixing of propellant and medical fluid by causing swirling. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a swirl chamber as taught by Loughlin to the device of Hoekman in order to promote fluid mixing. In order to provide these benefits, the swirl chamber taught by Loughlin must be provided in fluid communication with the opening and the coupling mechanism.
Regarding claim 39, the same analysis regarding naloxone discussed above with respect to claims 11-12 applies to these claims as well.
Claim(s) 8-10 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ekman in view of US Pre-Grant Publication US Pre-Grant Publication 2002/0151842 to Gonnelli et al. (Gonnelli).
Regarding claim 8, Ekman teaches the limitations of claim 1 from which claim 8 depends, but does not teach a seal member, first and second areas of the propellant chamber, or first and second components of the propellant. Gonnelli teaches a drug delivery device (Figs. 25-29, see paragraphs 153+) comprising a tip (260) having an opening therein which is configured to be placed in a nose, a propellant chamber (282) a drug chamber (262) with a drug therein (see paragraphs 3 and 153), a stopper (264) and an actuator (256) configured to be actuated to cause the propellant to propel the stopper toward the drug chamber and thereby the drug from the opening (paragraph 157). Furthermore, Gonnelli teaches separate components (within and without 284, see paragraph 157) within a seal member (284). As such, Ekman teaches a device which differs from the invention of claim 8 only in the use of a multiple component propellant, which subject matter is taught by Gonnelli. Accordingly, it would have been obvious at the time of the effective filing date of the invention to substitute the propellant and containment system thereof of Gonnelli for the propellant of Ekman as the mere substitution of one known propellant for another according to the known principles of construction and operation evinced by both references taken together. The examiner notes that the propellant of Gonnelli may be adjusted in composition or size of charge to adjust the force level applied, and that such optimization falls within the purview of one of ordinary skill in the art.
Regarding claim 9, Gonnelli teaches that the device automatically breaks the seal member (see paragraph 157).
Regarding claim 10, Gonnelli teaches that the charge may be vinegar and sodium bicarbonate (paragraph 181).
Regarding claim 17, Ekman teaches the limitations of claim 13 from which claim 17 depends, but does not teach a seal member, first and second areas of the propellant chamber, or first and second components of the propellant. Gonnelli teaches a drug delivery device (Figs. 25-29, see paragraphs 153+) comprising a tip (260) having an opening therein which is configured to be placed in a nose, a propellant chamber (282) a drug chamber (262) with a drug therein (see paragraphs 3 and 153), a stopper (264) and an actuator (256) configured to be actuated to cause the propellant to propel the stopper toward the drug chamber and thereby the drug from the opening (paragraph 157). Furthermore, Gonnelli teaches separate components (within and without 284, see paragraph 157) within a seal member (284). As such, Ekman teaches a device which differs from the invention of claim 17 only in the use of a multiple component propellant, which subject matter is taught by Gonnelli. Accordingly, it would have been obvious at the time of the effective filing date of the invention to substitute the propellant and containment system thereof of Gonnelli for the propellant of Ekman as the mere substitution of one known propellant for another according to the known principles of construction and operation evinced by both references taken together. The examiner notes that the propellant of Gonnelli may be adjusted in composition or size of charge to adjust the force level applied, and that such optimization falls within the purview of one of ordinary skill in the art.
Regarding claim 18, Gonnelli teaches that the charge may be vinegar and sodium bicarbonate (paragraph 181).
Response to Arguments
Applicant’s arguments, see page 8, filed 16 January 2026, with respect to the rejection(s) of claim(s) under 35 U.S.C. 102 over Gonnelli have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ekman as set forth above.
With respect to Gonnelli, Gonnelli is relied on herein only to teach the use of a multiple component propellant. As such, the arguments directed toward Gonnelli are largely moot. With particular respect to the force applied thereby, the examiner notes that the art is generally well aware of basic physics such as relative piston area pressure calculations and therefore those of ordinary skill in the art are capable of adjusting the force levels to the application of Ekman.
With respect to Hoekman, the examiner is not persuaded. The examiner has clarified the basis for the rejection above. Regarding the pumping mechanism, this has been mapped as separate from the propellant chamber and as being actuatable to pressurize the propellant chamber, as discussed above. Regarding the swirl chamber, the examiner notes that the applicant’s recitation of the feature in the claims is broad and is not limited to any particular chamber structure. Regarding the teaching thereof, the examiner understands Loughlin to indicate that swirl chambers are conventional elements which do not require further explanation. As applicant is not claiming any additional features of the swirl chamber, the disclosure in Loughlin is sufficient to render the claim limitation obvious. Furthermore, regarding placement, the entire fluid path of Hoekman is in mutual fluid communication, and as such any placement that acts on the two components of the propellant and the drug would necessarily meet the communication limitations of the claimed invention.
Conclusion
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 PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 12 May 2026
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