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
Acknowledgment is made of applicant’s claim for priority to Application No. (62/569,901) filed on the October 09, 2017.
Specification
The disclosure is objected to because of the following informalities:
On page 23, line 12, “the push member 334” should read “the push member 434”
Appropriate correction is required.
Claim Objections
Claims 2-5, 11, 14, and 17 objected to because of the following informalities:
Regarding Claims 2-5, 11, 14, line 1, a comma should be after "The aerosol delivery unit of claim 1”.
Regarding Claim 17, line 1, a comma should be after "The aerosol delivery unit of claim 16”.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 12, and 14 of U.S. Patent No. US 11833292 B2, hereafter as ‘292 in view of Trill et al. (US 20120180785 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that all the elements of claims 1 of the instant application is found in claims 1, 12, and 14 of the patent.
Regarding Claim 1, ‘292 discloses an aerosol delivery unit for selectively delivering a dose of aerosolized matter, the aerosol delivery unit comprising (claim 1):
a base housing (claim 12);
a valve stem (claim 1)
a mouthpiece aperture in fluid communication with the inhalation passageway through which the aerosolized matter is discharged during an inhalation event (claim 12);
a desiccant chamber containing a desiccant material, the desiccant chamber being in fluid communication with the discharge passageway at least when the aerosol delivery unit is in a storage configuration (claim 12);
and a seal member movable between a closed position, in which the seal member covers a discharge outlet of the discharge passageway to isolate the discharge passageway from the inhalation passageway, and an open position, in which the discharge outlet is in fluid communication with the inhalation passageway to allow the aerosolized matter to pass from the discharge passageway into the inhalation passageway for delivery to a user through the mouthpiece aperture (claim 14).
‘292 does not specifically disclose the canister containing matter to be aerosolized and including a valve stem that defines a portion of a discharge passageway extending from a discharge valve outlet of the canister to an inhalation passageway provided within the base housing.
However, Trill teaches a canister (Fig. 1; 60) at least partially received in the base housing (Fig. 1; 80), the canister containing matter (Fig. 1; 70) to be aerosolized (para. 0013; Examiner notes: discharge a metered volume of the drug formulation which acts as a spray orifice) and including a valve stem (Fig. 1; 7) that defines a portion of a discharge passageway (Fig. 2; 10) extending from a discharge valve outlet (Fig. 2; 11) of the canister to an inhalation passageway (Fig. 1; 83) provided within the base housing.
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 device ‘292 to include the canister containing matter to be aerosolized and including a valve stem that defines a portion of a discharge passageway extending from a discharge valve outlet of the canister to an inhalation passageway provided within the base housing as taught by Trill as it is well form of pMDI and the drug formulation is discharged into the stem block conduit and directed through the mouthpiece by the outlet end, which acts as a spray orifice (para. 0013).
Allowable Subject Matter
Claim 1 is rejected and will be allowed after overcoming the Double Patenting Rejection above.
Claims 2-17 are 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 an examiner’s statement of reasons for allowance: The closest prior art to the claimed subject matter is over the prior art of Trill et al. (US 20120180785 A1), Von Schuckmann (US 20090050149 A1), Mitchell et al. (US 3187748 A), Bowman et al. (WO 2009029029 A1) and Deaton et al. (US 20080173301 A1).
Regarding Claim 1, Trill discloses an aerosol delivery unit for selectively delivering a dose of aerosolized matter (Figs 1-4; para. 0013), the aerosol delivery unit comprising:
a base housing (Fig. 1; actuator 80 );
a canister (Fig. 1; 60) at least partially received in the base housing (Fig. 1; 80), the canister containing matter (Fig. 1; 70) to be aerosolized (para. 0013; Examiner notes: discharge a metered volume of the drug formulation which acts as a spray orifice) and including a valve stem (Fig. 1; 7) that defines a portion of a discharge passageway (Fig. 2; 10) extending from a discharge valve outlet (Fig. 2; 11) of the canister to an inhalation passageway (Fig. 1; 83) provided within the base housing;
a mouthpiece aperture (83) in fluid communication with the inhalation passageway (inside 83) through which the aerosolized matter (para. 0013) is discharged during an inhalation event (pressing ; 0013);
a desiccant material (Fig. 2, 18; para. 0089).
Trill does not disclose wherein the desiccant material is a desiccant chamber containing a desiccant material, the desiccant chamber being in fluid communication with the discharge passageway at least when the aerosol delivery unit is in a storage configuration; and a seal member movable between a closed position, in which the seal member covers a discharge outlet of the discharge passageway to isolate the discharge passageway from the inhalation passageway, and an open position, in which the discharge outlet is in fluid communication with the inhalation passageway to allow the aerosolized matter to pass from the discharge passageway into the inhalation passageway for delivery to a user through the mouthpiece aperture.
Von Schuckmann teaches an inhaler (Fig. 1; 1; para. 0011, a desiccant material (Fig. 1; 16) is a desiccant chamber (17) containing a desiccant material (Fig. 1);
the desiccant chamber being in fluid communication (18) with a discharge passageway (at air outlet 22) at least when an aerosol delivery unit (1) is in a storage configuration (as shown in Fig. 1).
Bowman teaches inhaler with similar structure and desiccant material (Fig. 1), but does not disclose seal member.
Mitchell et al. teaches a vane (69) vane being positioned to block the passage between said opening (71) and said mouthpiece (31). However, does not disclose desiccant chamber or any of the other structure limitations.
Deaton teaches a cover that blocks the mouthpiece or inhalation passageway; but does not teach a seal member that block the discharge outlet of the discharge passageway that is between the discharge outlet and inhalation passageway.
However, the prior art Trill, Von Schuckmann, Mitchell, Bowman, nor Deaton, above alone or in combination fail to disclose or render obvious of “a seal member movable between a closed position, in which the seal member covers a discharge outlet of the discharge passageway to isolate the discharge passageway from the inhalation passageway, and an open position, in which the discharge outlet is in fluid communication with the inhalation passageway to allow the aerosolized matter to pass from the discharge passageway into the inhalation passageway for delivery to a user through the mouthpiece aperture.” Therefore, independent claim 1 and claim 2-17 by dependency are not taught by the prior art.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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/MAAP ELLABIB/
Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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