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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 4/24/2026 has been entered.
Response to Amendment
This office action is responsive to an amendment filed on 2/18/2026. As directed by the amendment, claims 1 and 5-10 were amended, claims 18-35 were cancelled and no new claims were added. Thus, claims 1-17 are presently pending in this application.
Claim Rejections - 35 USC § 112
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 17 is 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 pre-AIA the applicant regards as the invention.
Regarding claim 17, the limitation “A drug product” is unclear if the drug product is the same as or different from “a drug” being claimed in claim 1, line 4. It is noted that claim 1 claims “a drug therein”, therefore, to further claim a “drug product” makes it unclear if the two are the same. Furthermore, it is unclear as to what is the relationship between the drug product and the drug being claimed in claim 1, line 4. Furthermore, it is unclear as to what the scope of the claim is, is the claim requiring a drug product and the device of claim 1 or just the drug product. Suggest to amend to --The device of claim 1, wherein the drug in each of the vials is one of ketamine, esketamine, naloxone, and sumatriptan--. For examination purposes, the limitation is being interpreted as -- The device of claim 1, wherein the drug in each of the vials is one of ketamine, esketamine, naloxone, and sumatriptan--.
Claim Objections
In the scenario that the drug product in claim 17 is the same as the drug being claimed in claim 1, claim 17 is being objected to under 37 CFR 1.75 as being a substantial duplicate of claim 14. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
(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 17 as best understood is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sullivan (2002/0092521).
Note: claim 17 is being rejected based on the interpretation that the drug delivery device of claim 1 is not being required by the claim.
Regarding claim 17, Sullivan discloses a drug product disposed in a device comprising ketamine (see paragraph 0047).
Allowable Subject Matter
Claims 1-16 are allowable.
The following is an examiner’s statement of reasons for indicating allowable subject matter: The closest prior art of record Graf (5,469,989), Wermeling (7,559,321) and Rex (5,542,411) do not specifically disclose the claimed apparatus as presented in the claims 1-16.
Graf discloses a drug delivery device (entire device in figs. 1-3), comprising: a tip (end portion of piece (34, 11, 15, 36, and 35), which has a tapered end portion comprising opening 14 that is capable being inserted into the nose of the patient, see container 7 in fig. 1 and col 2, lines 52-57, Graf discloses that each discharge, a new, sealed container is broken open, which only has to have a storage volume of approximately 0.1 ml. Such discharge apparatus can be very small in dimensions of e.g. approximately a diameter of 5 cm, therefore, from the disclosure of the size of the device and the volume of the container, the tip comprising 14 would be able to be inserted into the nose of the patient) configured to be positioned in a nose of a patient, the tip having an opening (14, fig. 2, col 3, lines 23-31) therein; a cartridge (2 and containers 5, fig. 2, col 3, line 18 to col 4, line 24) configured to seat a plurality of vials (5, fig. 2, col 3, lines 23-44) that each contain a drug (see medium being discharged through the outlet in col 2, lines 1-33 and claim 1, furthermore, see col 1, lines 11-14, Graf discloses that the invention relates to a discharge apparatus for flowable media, but in particular a liquid state that is mainly used for cosmetic or pharmaceutical purposes, a liquid for pharmaceutical purposes would be a drug), a first one of the vials being aligned with the tip (see the annotated-Graf figs. 1-3 in the non-final rejection, as shown, there is a first vial that is aligned with the tip), but fails to disclose a plunger configured to be actuated to cause the drug in a first one of the vials to be delivered through the opening and to cause the cartridge to rotate relative to both the tip and the plunger such that the first one of the vials is misaligned from the tip and a second one of the vials is aligned with the tip.
Wermeling teaches a tip (tip comprising 18 of 30, fig. 3) configured to be positioned in a nose of a patient and a drug comprising (see col 2, lines 10-21 and col 8, lines 26-41 and abstract).
Rex teaches a plunger (24, fig. 6) configured to be actuated to cause a magazine (40 comprising 48, 41, fig. 6) comprising a drug in a first chamber (41, fig. 6) to rotate relative to an outlet pipe (46) and the plunger such that the first chamber of the magazine (40) is misaligned from the tip and a second one of the magazine is aligned with the tip (col 4, line 56 to col 7, line 5).
Graf, Wermeling and Rex fail to disclose the combination of a drug delivery device comprising a cartridge configured to seat a plurality of vials, each vial of the plurality of vials containing a drug therein, a first one of the vials being aligned with the tip and a plunger configured to be actuated to cause the drug in a first one of the vials to be delivered through the opening and to cause the cartridge to rotate relative to both the tip and the plunger such that the first one of the vials is misaligned from the tip and a second one of the vials is aligned with the tip. Therefore, to modify Graf, Wermeling and Rex to arrive at the claimed invention would not have been obvious and would be based upon improper hindsight reasoning.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TU A VO whose telephone number is (571)270-1045. The examiner can normally be reached Monday-Friday 9:00 AM - 6:00 PM EST.
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/TU A VO/Primary Examiner, Art Unit 3785
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