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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/06/2025 and 06/15/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of group II in the reply filed on 05/04/2026 is acknowledged.
Applicant identifies that claims 2-16, as amended, and claims 17 and 21-22 encompass the elected invention.
Response to Amendment
This office action is responsive to the amendment filed on 05/04/2026. As directed by the amendment: claims 2-17 have been amended. Claim 1 has been cancelled. Claims 21 and 22 have been added.
Thus, claims 2-22 are pending in this application with claims 18-20 being withdrawn.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Reference number 62 in figures 3 and 4 is not in the description.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
References numbers 40, 42, 46 and 48 mentioned in the specification are not in the drawings.
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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “18” has been used to designate both the body of device 12 and the bottom wall of the secondary packaging 10.
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. 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.
Specification
The disclosure is objected to because of the following informalities:
Para 0041, line 1, “devices 10” should read “devices 12”.
Para 0045, line 2, “discharge port 46” should read “discharge port 48”.
Para 0056, line 5, “actuator 44” should read “actuator 41”.
Para 0056, lines 6-7, “the cap 16 toward bottom wall 18 when the cap 16” should “the cap 26 toward bottom wall 18 when the cap 26 is”.
Para 0058, line 2, “actuator 44” should read “actuator 41”.
Para 0059, line 2 and 7, “actuator 44” should read “actuator 41”.
Para 0060, lines 2 and 4, “actuator 44” should read “actuator 41”.
Appropriate correction is required.
Claim Objections
Claim 16 is objected to because of the following informalities:
Claim 16, line 2, “the packaging” should read “the secondary packaging”.
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 16 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 16 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 16 recites the limitation "the rim " in line 3. There is insufficient antecedent basis for this limitation in the claim.
Examiner is unsure when the rim is formed on the cap or the body of secondary packaging.
Clarification is required.
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.
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 2, 6-8, 10, 11, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Arnett et al (US 20200306137 A1) in view of Ries et al (US 20150196867 A1).
Regarding claim 17, Arnett et al disclose a medication delivery system (10 in fig 1) comprising: a drug delivery device (12) stored in a secondary packaging (14), the drug delivery device (12) comprising a body (18) having a discharge end (20) defining a drug discharge port (24) and an opposed actuator end (22), the drug delivery device including a drug reservoir (18) having a drug stored therein (para 0028), the drug delivery device (12) further including an actuator (26) for ejecting the drug from the reservoir through the discharge port (para 0029), the actuator extending out of the actuator end of the body (fig 1, para 0029), the actuator being linearly movable from an extended position to a depressed position (para 0029), the discharge port (24) being sealed when the actuator is in the extended position and the discharge port being open when the actuator is in the depressed position, the actuator being operable to discharge the drug from the reservoir upon axial movement of the actuator from the extended position to the depressed position (para 0029); the secondary packaging (14) comprising a body (28) defining a cavity (32) for at least partially surrounding the drug delivery device (fig 2 and para 0030), a cap (16) attached to at least a portion of the body by a hinge (50), the cap being movable with respect to the body between a closed position and an open position (para 0031), the body and cap together defining an internal compartment for housing the drug delivery device when the cap is in the closed position (fig 3, para 0031), and an active polymer component (70) located within the internal compartment (fig 3), the active polymer component being configured to receive at least a portion of the drug delivery device therein (fig 3, para 0048); wherein the drug delivery device (12) is configured for intranasal administration (para 0026) and the drug, when administered, is in the form of a liquid, an aerosol, a gel or a powder (para 0051-52 and 0086), and 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 (para 0003 and 0053, glucagon is used).
Arnett et al fail to disclose the active polymer component comprising a mixture of 3A molecular sieve and a base polymer but teach the desiccant plug (70) may be formed, for example, as an injection molded plug of a molecular sieve type, using known materials to absorb moisture that may otherwise degrade the medication (para 0049).
However, Ries et al disclose a medical device (1 in figs 1F-G) comprising an active component polymer (30/230) wherein the active polymer component comprising a mixture of 3A molecular sieve and a base polymer (para 0079 and 0097-98).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the active polymer component comprising a mixture of 3A molecular sieve and a base polymer as taught by Ries et al. This would provide the benefit of a desiccant mixed with a polymer which leads to a moisture absorption to be a permeation-absorption controlled process, for instance moisture permeates through the polymer carrier and is absorbed into the desiccant embedded inside (para 0088).
Regarding claim 2, Arnett et al in view of Ries et al disclose the medication delivery system of claim 17,
Arnett et al further disclose where the body of the secondary packaging is cylindrical (para 0030) and comprises a base (30) and a sidewall (28) extending upwardly therefrom (figs 1-2).
Regarding claim 6, Arnett et al in view of Ries et al disclose the medication delivery system of claim 2,
Arnett et al further disclose wherein the cap (16) of the secondary packaging (14) further comprises a latch (58) that engages mating geometry of the cap in the closed position to retain the cap in the closed position and thereby inhibit inadvertent opening of the cap (fig 5 and para 0009 and 0043).
Regarding claim 7, Arnett et al in view of Ries et al disclose the medication delivery system of claim 6,
Arnett et al further disclose wherein the latch (58) comprises at least one opening (62) and the body includes at least one rib (64) configured to mate with the at least one opening in a snap-fit configuration (fig 6 and para 0043).
Regarding claim 8, Arnett et al in view of Ries et al disclose the medication delivery system of claim 6,
Arnett et al further disclose said system comprising a plug or a lip seal (68) depending from a base of the cap (fig 6), the plug or lip seal being configured to engage an inner surface of the sidewall to form a moisture tight seal between the cap and the body (para 0046).
Regarding claim 10, Arnett et al in view of Ries et al disclose the medication delivery system of claim 2,
Arnett et al further disclose wherein the active polymer component (70) of the secondary packaging (14) is attached to or integral with the sidewall of the body of the secondary packaging (fig 3), the active polymer component comprising a central axial cavity configured to receive and surround a portion of the drug delivery device (fig 8).
Regarding claim 11, Arnett et al in view of Ries et al disclose the medication delivery system of claim 10,
Arnett et al further disclose wherein the central cavity (32) terminates at an annular ledge (77) configured to provide a seating surface for an annular flange of the body of the drug delivery device (figs 3 and 8).
Regarding claim 16, Arnett et al in view of Ries et al disclose the medication delivery system of claim 17,
Arnett et al further disclose wherein the cap of the packaging comprises a base (16/41), at least a portion of which is vaulted to project vertically above the rim (66) when the cap is in the closed position (fig 3) and thus form a recess (40) within the cap configured to house a portion of the drug delivery device (fig 3 and para 0032).
Claims 3-5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Arnett et al (US 20200306137 A1) in view of Ries et al (US 20150196867 A1) and further in view of Freedman et al (US 20200255206 A1).
Regarding claim 3, Arnett et al in view of Ries et al disclose the limitations of claims 17 and 2 but fail to teach wherein an end of the sidewall of the secondary packaging opposite the base includes a rim that defines an opening leading to the cavity.
However, Freedman et al disclose a container (10 in fig 1) comprising a sidewall (16), a cavity (18) and a base (14) wherein an end of the sidewall of the secondary packaging opposite the base includes a rim (20) that defines an opening leading to the cavity (fig 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify said secondary packaging of Arnett et al to have an end of the sidewall of the secondary packaging opposite the base includes a rim that defines an opening leading to the cavity as taught by Freedman et al. This would provide the benefit of a rim that extends into an interior of said cap when said cap is in closed position to provides a closing position, e.g., via a snap-fit mating configuration, to retain said cap in the closed position and prevent it from inadvertently opening (para 0067).
Regarding claim 4, Arnett et al in view of Ries et al and Freedman et al disclose the medication delivery system of claim 3,
Freedman et al further disclose wherein the cap (24) of the secondary packaging (12) has an annular skirt (32, fig 1) extending downwardly from a periphery of a base (30) of the cap, the skirt (32) having a first end proximate the base and an opposing second free end (figs 1-2, para 0064).
Regarding claim 5, Arnett et al in view of Ries et al and Freedman et al disclose the medication delivery system of claim 4,
Freedman et al further disclose wherein the rim (20) has an outer surface (46) comprising an undercut (46) relative to a central axis of the body, the undercut having a surface that mates with a corresponding surface of the skirt in a snap fit closure configuration when the cap is closed, wherein the snap fit closure configuration inhibits inadvertent opening of the cap and forms a moisture-tight seal between the body and the cap (para 0067 and 0086, fig 2).
Regarding claim 9, Arnett et al in view of Ries et al and Freedman et al disclose the medication delivery system of claim 5,
Freedman et al further disclose said system further comprising an elastomeric seal (42a) on an underside of the cap of the secondary packaging configured to engage at least a portion of the body when the cap is in the closed position to form a moisture tight seal between the cap and the body (fig 2, para 0046, 0068-69).
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Arnett et al (US 20200306137 A1) in view of Ries et al (US 20150196867 A1) and further in view of Winterton et al (US 20120152284 A1).
Regarding claim 12, Arnett et al in view of Ries et al disclose the limitations of claim 17 and further disclose wherein when the cap (16) of the secondary packaging (14) is in the closed position, the secondary packaging is moisture tight (fig 3 and para 0031 and 0046) but fail to teach wherein at a storage temperature of 50 degrees C, the active polymer component generates an initial release of gas causing pressure to build up within the internal compartment and to reach a peak pressure, followed by a decrease of pressure within the internal compartment while the cap remains in the closed position.
However, Winterton et al disclose cap (50 in fig 2) and a container (20) having an internal component (90) in an internal compartment (fig 2) wherein the internal component generates an initial release of gas causing pressure to build up within the internal compartment and to reach a peak pressure, followed by a decrease of pressure within the internal compartment while the cap remains in the closed position (para 0025, - Release of the excess gas reduces the pressure within the contained volume back below the threshold pressure, fig 4A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the active polymer component generates an initial release of gas causing pressure to build up within the internal compartment and to reach a peak pressure, followed by a decrease of pressure within the internal compartment while the cap remains in the closed position as taught by Winterton et al. This would provide the benefit to avoid inadvertently opening of said cap from said secondary packaging until a user removes said cap by unscrewing for usage (para 0027).
Winterton et al fail to disclose the active polymer component generates an initial release of gas causing pressure to build up within the internal compartment and to reach a peak pressure, followed by a decrease of pressure within the internal compartment while the cap remains in the closed position at a storage temperature of 50 degrees C.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the system of Arnett et al in view of Ries et al and Winterton et al to have storage temperature of 50 degrees C since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the system of Arnett et al in view of Ries et al and Winterton et al would not operate differently with the claimed temperature and the system would function appropriately having the claimed temperature. Further, applicant places no criticality on the temperature claimed, indicating simply that the diameter “may” be within the claimed ranges (specification pp. [0091]).
Regarding claim 13, Arnett et al in view of Ries et al and Winterton et al disclose the medication delivery system of claim 12, but fail to expressly disclose wherein the peak pressure is reached within one day after the cap is placed in the closed position.
Winterton et al disclose the peak pressure is reached after the cap is placed in the closed position (para 0025).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to have the peak pressure is reached within one day after the cap is placed in the closed position as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 14, Arnett et al in view of Ries et al and Winterton et al disclose the medication delivery system of claim 12, but fail to expressly teach wherein the peak pressure is from 80 mBars to 120 mBars and the final pressure is from 40 mBars to 60 mBars.
Winterton et al disclose a peak pressure and a reduced pressure to keep a cap in closed position (fig 4A and para 0025).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the peak pressure is from 80 mBars to 120 mBars and the final pressure is from 40 mBars to 60 mBars since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, since Winterton et al disclose a peak pressure and a reduced pressure to keep a cap in closed position (para 0025). Further, applicant places no criticality on the range claimed, indicating simply that the pressure “may” be within the claimed ranges (specification pp. [0098-97]).
Regarding claim 15, Arnett et al in view of Ries et al and Winterton et al disclose the medication delivery system of claim 12,
Winterton et al further disclose wherein pressure built up within the internal compartment is not sufficient to cause the cap of the secondary packaging to inadvertently open (para 0025, when there is a build up pressure inside said container, cap is still attached to the container but the sealing interface between the lip of the cap and the rim of the container cup are disengaged until gas is released to reduce pressure and keep said cap in closed position, figs 4A-4B).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Arnett et al (US 20200306137 A1) in view of Ries et al (US 20150196867 A1) and further in view of Caffrey (US 6284765 B1).
Regarding claim 21, Arnett et al in view of Ries et al disclose the limitations of claim 17 but fail to teach wherein the drug is a formulation comprising Epinephrine.
However, Caffrey discloses a system (abstract) wherein the drug is a formulation comprising Epinephrine (col 2, lines 32-40).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the drug is a formulation comprising Epinephrine as taught by Arnett et al. This would provide the benefit of having a drug formulation that is highly desirable in treating asthmatic attack, nasal congestion due to cold, allergies, and other diseases involving airway compromise (col 2, lines 32-40).
Regarding claim 22, Arnett et al in view of Ries et al disclose the limitations of claim 17 but fail to teach wherein the drug is a formulation comprising Naloxone.
However, Caffrey discloses a system (abstract) wherein the drug is a formulation comprising Naloxone (col 4, lines 23-40).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the drug is a formulation comprising Naloxone as taught by Arnett et al. This would provide the benefit of having a drug formulation in the treatment of breathing passageway compromise (col 4, lines 23-40).
Conclusion
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 09/28/2026
