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 .
Priority
Acknowledgement is made to Applicant’s claim to priority to PCT/US2023/028826 filed July 27, 2023 and to U.S. Provisional App. No. 63/370,045 filed August 1, 2022.
Status of Claims
This Office Action is responsive to the amendment filed on April 2, 2026. As directed by the amendment: claims 2-13 and 27 have been amended; claims 1 and 14-19 have been cancelled; and claims 29-37 have been added. Thus, claims 2-13 and 27-37 are presently pending in this application.
Election/Restrictions
Restriction to one of the following inventions was previously required under 35 U.S.C. 121:
I. Claims 1-13, drawn to a secondary packaging, classified in B65D25/105.
II. Claims 14-19, drawn to a method of attaching at least one device for administering a drug to a secondary packaging, classified in A61M2209/082.
III. Claims 27-28, drawn to a method for treating a patient, classified in A61M15/009.
Applicant’s election without traverse of Group III in the reply filed on April 2, 2026 is acknowledged.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “the discharge port being sealed when the actuator is in the extended position and the discharge port being open when the actuator is in the depressed position” recited in claim 27 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 recites “the body is configured”, ln 2 should read --the body of the secondary packaging is configured--;
Appropriate correction is required.
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 34 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 34 recites the limitation "further comprising: disengaging at least one of the spaced-apart prongs from the drug delivery device", ln 1-2. There is insufficient antecedent basis for the “at least one of the spaced-apart prongs limitation” in the claim. The limitation “at least one of the spaced-apart prongs” was initially introduced in claim 4, while claim 34 depends form claim 3. For the purpose of this Office Action claim 34 has been interpreted as depending form claim 4.
Claim Rejections - 35 USC § 103
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.
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) 2, 3, 7-12, 27-28, 33, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Le Maner (U.S. Pub. No. 2016/0271320) in view of Arnett et al. (U.S. Pat. No. 10,765,602; hereinafter: “Arnett”).
Regarding Claim 27, Le Maner discloses a method of treating a patient in need of a drug that is administered intranasally, the method comprising: providing a secondary packaging (100; Fig. 1, 2, 7, 8), the secondary packaging comprising a body (A, Fig. B annotated below) including at least one clip (130, 151, 152, 153, 154; Fig. 1, 2, 7, 8) attached to an interior surface (B, Fig. B annotated below) thereof, the at least one clip being configured to surround at least a portion (C, Fig. B annotated below) of the drug delivery device, the clip being configured to prevent inadvertent removal or movement of the drug delivery device with respect to the body (¶¶ 0030-0036); and a cap (D, Fig. B annotated below) pivotably attached to the body (¶ 0026; Fig. 1), the cap and the body combining to form a cavity (C, Fig. A annotated below) for holding the drug delivery device when the cap is in a closed position with respect to the body (Fig. 2).
PNG
media_image1.png
473
316
media_image1.png
Greyscale
Figure A, Adapted from Figure 2 of Le Maner.
PNG
media_image2.png
310
402
media_image2.png
Greyscale
Figure B, Adapted from Figure 1 of Le Maner.
Le Maner does not specifically disclose the method comprising inserting the discharge end into a nostril of the patient; and actuating the drug delivery device to intranasally administer the drug to the patient.
Arnett teaches a method comprising providing a drug delivery device (12; Fig. 1-4) comprising a body (20, 24; Fig. 1) having a discharge end (20; Fig. 1) defining a drug discharge port (24; Fig. 1), the drug delivery device including a drug reservoir having a drug stored therein (col 4, ln 4-17), the drug delivery device further including an actuator (26; Fig. 1-4) for ejecting the drug from the reservoir through the discharge port (col 4, ln 4-47; col 4, ln 27 to col 5, ln 33), the actuator being linearly movable from an extended position to a depressed position (Claim 1, 20), the discharge port being sealed when the actuator is in the extended position and the discharge port being open when the actuator is in the depressed position (col 4, ln 4-17; Claim 20) and inserting the discharge end into a nostril of the patient (col 3, ln 29-43; col 9, ln 23-35; Claim 18); and actuating the drug delivery device to intranasally administer the drug to the patient (col 3, ln 29-43; col 9, ln 23-35; Claim 18) for the purpose of delivering the drug to the nasal mucosa resulting in a highly effective protection for the viability of drug (col 9, ln 23-35).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Le Maner to include inserting the discharge end into a nostril of the patient; and actuating the drug delivery device to intranasally administer the drug to the patient as taught by Arnett for the purpose of delivering the drug to the nasal mucosa resulting in a highly effective protection for the viability of drug (See Arnett: col 9, ln 23-35).
Regarding Claim 2, the modified method of Le Maner discloses the method wherein the drug delivery device is a nasal dose inhaler (See Arnett: col 3, ln 29-43; col 9, ln 23-35; Claim 18).
Regarding Claim 3, the modified method of Le Maner discloses the method wherein the body is configured such that the at least one clip can only receive the drug delivery device when the drug delivery device is pointing in one direction (See Le Maner: Fig. 1-2).
Regarding Claim 7, the modified method of Le Maner discloses the method wherein, when the at least one drug delivery device is attached to the body, the body is configured to prevent movement of the at least one drug delivery device that would otherwise release or administer the drug (See Le Maner: ¶¶ 0030-0036).
Regarding Claim 8, the modified method of Le Maner discloses the method wherein when the drug delivery device is attached to the body, the at least one drug delivery device defines a device axis (A, Fig. C annotated below) that extends at an angle (B, Fig. C annotated below) with respect to a hinge axis (C, Fig. C annotated below), where the angle is from 10˚-80˚.
PNG
media_image3.png
332
398
media_image3.png
Greyscale
Figure C, Adapted from Figure 1 of Le Maner.
Regarding Claim 9, the modified method of Le Maner discloses the method wherein the at least one clip includes two spaced-apart and arcuate arms (See Le Maner: 151, 152 and 153, 154; Fig. 1, 2).
Regarding Claim 10, the modified method of Le Maner discloses wherein each arcuate arm of the at least one clip includes a first portion (A, Fig. D annotated below) that is concave with respect to the device axis and at least one second portion (B, Fig. D annotated below) that is convex with respect to the device axis.
PNG
media_image4.png
500
592
media_image4.png
Greyscale
Figure D, Adapted from Figure 1 of Le Maner.
Regarding Claim 11, the modified method of Le Maner discloses the method of claim 27, shown above.
The modified method of Le Maner does not specifically disclose the method wherein the cap includes a latch extending at least partially therefrom, the latch being configured to engage at least one projection extending from an exterior surface of the body.
Arnett teaches the method comprising a cap (16; Fig. 1-7) including a latch (58; Fig. 6) extending at least partially therefrom (Fig. 1-4, 6; col 7, ln 4 to col 8, ln 12), the latch being configured to engage at least one projection (64; Fig. 2, 4, 6) extending from an exterior surface of the body (Fig. 1, 2, 4, 6; col 7, ln 4 to col 8, ln 12) for the purpose of providing a latch with sufficiently flexible and resilient for the latch to be opened and closed as required (col 7, ln 20-22).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified method of Le Maner to include the cap including the latch extending at least partially therefrom, the latch being configured to engage at least one projection extending from the exterior surface of the body as taught by Arnett for the purpose of providing a latch with sufficiently flexible and resilient for the latch to be opened and closed as required (See Arnett: col 7, ln 20-22).
Regarding Claim 12, the modified method of Le Maner discloses the method wherein the latch includes an opening (See Arnett: 62; Fig. 6) therein, an outer periphery of the opening being configured to engage the at least one projection when the secondary packaging is in the closed position (See Arnett: col 7, ln 4 to col 8, ln 12).
Regarding Claim 28, the modified method of Le Maner discloses the method wherein the drug is a formulation comprising one or more of the following active pharmaceutical ingredients: Naloxone, Ketamine, Midazolam, Fentanyl, Lorazepam, Nalmefene, Epinephrine, Apomorphine, Cetrorelix, Loxapine, Eletriptan, Ketorolac, Glucagon and Olanzapine (See Arnett: col 9, ln 14-35).
Regarding Claim 32, the modified method of Le Maner discloses the method wherein the drug is a formulation comprising Glucagon (See Arnett: col 9, ln 14-35).
Regarding Claim 33, the modified method of Le Maner discloses the method further comprising: disengaging the at least one clip from the drug delivery device before removing the drug delivery device from the secondary packaging [See Le Maner: ¶ 0036; Examiner notes: Le Maner discloses the at least one clip (151, 152, 153, 154) disengaging the drug delivery device before removing the drug delivery device from the secondary packaging.].
Regarding Claim 35, the modified method of Le Maner discloses the method wherein further comprising: disengaging at least one spaced-apart and arcuate arm from the drug delivery device (See Le Maner: ¶ 0036; Fig. 1; Examiner notes: Le Maner discloses when the secondary packaging is in the opened position the at least one spaced-apart and arcuate arm are disengaged from the drug delivery device)
Regarding Claim 36, the modified method of Le Maner discloses the method further comprising: separating the latch from the projection extending from an exterior surface of the secondary packaging (See Arnett: Fig. 1, 2, 4, 6; col 7, ln 4 to col 8, ln 12).
Claim(s) 4, 5, 13, 34, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Le Maner in view of Arnett as applied to claim 3 above, and further in view of Fuchs et al. (U.S. Pat. No. 6,708,846; hereinafter: “Fuchs”).
Regarding Claim 4, the modified method of Le Maner discloses the method, shown above.
The modified method of Le Maner does not specifically disclose the method wherein at least two spaced-apart prongs extend inwardly or upwardly from the interior surface of the body, the at least two spaced-apart prongs being spaced-apart from the at least one clip.
Fuchs teaches a method comprising providing a drug delivery device (11; Fig. 43) and providing a secondary packaging (37, 44; Fig. 37) comprising a body (37; Fig. 43) including at least one clip (150; Fig. 43) attached to an interior surface thereof; (col 15, ln 30-38), wherein at least two spaced-apart prongs (44; Fig. 43) extend inwardly or upwardly from the interior surface of the body (Fig. 43; col 15, ln 17-26), the at least two spaced-apart prongs being spaced-apart from the at least one clip (Fig. 43) for the purpose of maintaining positioning of the drug delivery device during violent movements (col 15, ln 17-26).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified method of Le Maner to include the at least two spaced-apart prongs extend inwardly or upwardly from the interior surface of the body, the at least two spaced-apart prongs being spaced-apart from the at least one clip as taught by Fuchs for the purpose of maintaining positioning of the drug delivery device during violent movements (See Fuchs: col 15, ln 17-26).
Regarding Claim 5, the modified method of Le Maner discloses wherein the at least two spaced-apart prongs comprise at least four spaced-apart prongs (A-E; Fig. E annotated below).
PNG
media_image5.png
578
540
media_image5.png
Greyscale
Figure E, Adapted from Figure 43 of Fuchs.
Regarding Claim 13, the modified method of Le Maner discloses the method, shown above.
The modified method of Le Maner does not specifically disclose the method wherein the step of providing the drug delivery device comprises providing a first drug delivery device and an identical second drug delivery device first drug delivery device and second drug delivery device two devices extending in opposite directions when attached to the body.
Fuchs teaches a method comprising providing a drug delivery device (11; Fig. 43) and providing a secondary packaging (37, 44; Fig. 37) comprising a body (37; Fig. 43) including at least one clip (150; Fig. 43) attached to an interior surface thereof; (col 15, ln 30-38), wherein at least two spaced-apart prongs (44; Fig. 43) extend inwardly or upwardly from the interior surface of the body (Fig. 43; col 15, ln 17-26), wherein the step of providing the drug delivery device comprises providing a first drug delivery device (F, Fig. E annotated above) and an identical second drug delivery device (G, Fig. E annotated above), the first drug delivery device and second drug delivery device two devices extending in opposite directions when attached to the body (Fig. 43) for the purpose of allowing the carrying of several drug delivery devices (col 5, ln 1-7).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Le Maner to include the step of providing the drug delivery device comprises providing a first drug delivery device and an identical second drug delivery device, the first drug delivery device and second drug delivery device two devices extending in opposite directions when attached to the body as taught by Fuchs for the purpose of allowing the carrying of several drug delivery devices (See Fuchs: col 5, ln 1-7).
Regarding Claim 34, the modified method of Le Maner discloses the method further comprising: disengaging at least one of the spaced-apart prongs from the drug delivery device (See Fuchs: Fig. 43; col 15, ln 17-26).
Regarding Claim 37, the modified method of Le Maner discloses the method, shown above.
The modified method of Le Maner does not specifically disclose the method further comprising: retaining a second drug delivery device in the secondary packaging.
Fuchs teaches a method comprising providing a drug delivery device (11; Fig. 43), providing a secondary packaging (37, 44; Fig. 37) comprising a body (37; Fig. 43) including at least one clip (150; Fig. 43) attached to an interior surface thereof; (col 15, ln 30-38), and retaining a second drug delivery device (F and G, Fig. E annotated above) in the secondary packaging allowing the carrying of several drug delivery devices (col 5, ln 1-7).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified method of Le Maner to include the retaining the second drug delivery device in the secondary packaging as taught by Fuchs for the purpose of allowing the carrying of several drug delivery devices (col 5, ln 1-7).
Claim(s) 29-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Le Maner in view of Arnett as applied to claim 28 above, and further in view of Lane (U.S. Pub. No. 2006/0207596).
Regarding Claims 29-31, the modified method of Le Maner discloses the method, shown above.
The modified method of Le Maner does not specifically disclose the method wherein the drug is a formulation comprising Naloxone, Ketamine, and/or Epinephrine.
Lane teaches a drug delivery device (2; Fig. 5) including a drug; wherein the drug is a formulation comprising Naloxone, Ketamine, and Epinephrine (¶ 0094) for the purpose of pain management, treating narcotic overdose, and treating cardiac issues, respectively (¶ 0094).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified method of Le Maner to include the drug is a formulation comprising Naloxone, Ketamine, and/or Epinephrine as taught by Lane for the purpose of pain management, treating narcotic overdose, and treating cardiac issues, respectively (See Lane: ¶ 0094).
Allowable Subject Matter
Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Prior art of Le Maner, Arnett, Fuchs, and Lane alone or in combination fail to disclose or render obvious the method wherein two of the at least four spaced-apart prongs are on a first side of a device axis that extends at an angle with respect to a hinge that attaches the body to the cover, and wherein two of the at least four spaced-apart prongs are on a second side of the device axis, as recited in dependent claim 6.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIOT S RUDDIE whose telephone number is (571)272-7634. The examiner can normally be reached M-F usually 9-7 EST.
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, Kendra Carter can be reached on (571) 272-9034. 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.
/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785
Prosecution Insights