Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission has been entered.
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.
Claims 1, 14, and dependents therein are 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 1 has been rejected under for the limitation “wherein… the housing is gripped and the housing is pivoted relative to the mouthpiece”. The limitation is directed to the process of using the device, whereas claim 1 is directed to the different statutory category of the product (inhaler device). As such, the metes and bounds of the claim limitation are unclear. Examiner recommends amending the phrase with “configured to” language (see below remarks under “Allowable Subject Matter”).
Claims 1 and 14 are rejected for the limitation “the housing is pivoted relative to the mouthpiece”. The language is awkward because the mouthpiece is pivoted rather than the housing. See for example Fig. 15A versus Fig. 15J. A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. See MPEP 2173.03. Examiner recommends amending the phrase as outlined below under “Allowable Subject Matter”.
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.
Claims 1 – 3, 5 – 16, and 19 – 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. US 11185645 (hereinafter “’645”) in view of Rand (US 6748946) in view of Elliot (US 4570630).
Regarding claim 1 of the instant application, claim 7 in ‘645 discloses an inhaler comprising: a housing (see claim 6, from which claim 7 is dependent), a mouthpiece (see claim 1, from which claim 7 is dependent), and a sled or slide tray (see claim 1), wherein the sled or slide tray is moveably attached to the housing (see claim 7, the sled or slide tray is attached to the housing at the distal end of the inhaler along with the mouthpiece, which actuates movement of the attached sled or slide trey per claim 1) and wherein the mouthpiece is configured to pivot relative to the housing (see claim 7, the mouthpiece pivots on the housing) and wherein pivoting moves the sled or slide tray (see claim 1, movement of the mouthpiece moves the sled or slide trey to move the container relative to the lid from a powder containment position to a dosing position; this is accomplished via pivoting of the mouthpiece, since claim 7 discloses that pivoting of the mouthpiece attains the open/loading position and dosing position; the open/loading position is a powder containment position prior to dosing).
However, claim 7 of ‘645 does not disclose wherein the sled or slide tray is attached to the mouthpiece by a cam, a gear, or a combination thereof. Nonetheless, Rand discloses an inhaler wherein the sled or slide tray (40) is attached to the mouthpiece by a cam, a gear, or a combination thereof (74), and moveably attached to the housing (see Figs. 2a and 2b). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify the mouthpiece of ‘645 according to the gear connection disclosed in Rand for the benefit of actuating movement of the sled. Note also discussion of Rand in previous non-final dated 12/17/2024.
Claim 7 of ‘645 additionally does not disclose wherein a grasping area at a proximal end of the housing is configured to be gripped and the mouthpiece is pivoted relative to the housing. However, as illustrated in Figs. 2a and 2b of Rand, the bottom part of housing 10 proximal to gear 74 is fully capable of providing a grasping area for gripping as the mouthpiece 90 is moved relative to the housing. Rand additionally discloses other embodiments in which an elastomeric strip 318 is provided for gripping, see Fig. 7a and 7b, thus providing a grasping area at a proximal end of the housing that is configured to be gripped, and the mouthpiece is pivoted relative to the housing. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify claim 7 of claim ‘645 with a proximal grasping area for the benefit of ease of grip, see Rand, c. 5: 26 – 27.
However, claim 7 of ‘645 and Rand do not explicitly mention the air conduit of the mouthpiece as rigid. However, Elliot discloses a dry powder inhaler comprising a housing and a mouthpiece (see Fig. 1), wherein the air conduit of the mouthpiece is rigid (c. 4: 46 – 57). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to construct the mouthpiece of ‘645 in view of Rand from rigid material for the benefit of resisting impact, e.g. should the inhaler drop, as well as for using readily-available cost-effective plastic materials in constructing the inhaler.
Dependent claims 2 – 3, 5 – 8, 12 – 17, and 19 – 23 are additionally rejected over similar dependent claims in ‘645. Dependent claims 9 – 11 are further rejected as obvious over Gelber, Leone-Bay, and Bloomer, as set forth the action above. With respect to claim 23, it is noted that claim 7 in ‘645 anticipates rotation of the mouthpiece in order to open the inhaler to load or unload the cartridge (see claim 7, “the mouthpiece pivots on the housing to attain an open or loading position” of the cartridge). Rand discloses wherein the grasping area is configured to aid a user of the inhaler to firmly or securely grip the inhaler during rotation of the mouthpiece (see Figs. 2a/2b and Figs/ 7a/7b, strip 318 in the discussion above). Therefore, upon modifying the rotating mouthpiece of ‘645 with the grasping area of Rand as discussed above, the combination renders obvious the grasping area configured to aid a user of the inhaler to firmly or securely grip the inhaler to open the inhaler to load or unload the cartridge.
Claims 1, 14, and additional dependents are also rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. US 8499757 in view of Rand in view of Elliot. Please see the above double patenting rejection to USPN ‘645 in view of Rand in view of Elliot for the similar explanation.
Claims 1, 14, and additional dependents are also provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of US Patent No. 12447293 B2 in view of Rand in view of Elliot. Please see the above double patenting rejection to USPN ‘645 in view of Rand in view of Elliot for the similar explanation.
Allowable Subject Matter
The following claim limitation has been drafted by the examiner and is considered to distinguish patentably over the double patenting rejections remaining in this application, presented to applicant for consideration:
“wherein a grasping area at a proximal end of the housing entirely underneath a rigid air conduit of the mouthpiece is configured to be [[is]] gripped and the mouthpiece housing
Examiner notes that the claims as currently presented have overcome closest the prior art of record. See the non-final rejection dated 12/17/2024 rejected over Rand (US 6748946) and ensuing amendment; the final rejection dated 03/31/2025 rejected over Steiner (US 20040182387) and ensuing amendment; and, the non-final rejection dated 08/14/2025 rejected over Pinon (US 20060185672) and ensuing amendment. Limitations for overcoming the prior art are clear from the prosecution history as outlined, but a review of the references will be further provided upon placement of the claims in condition for allowance.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
Applicant argues that Rand does not disclose wherein a grasping area at a proximal end of the housing is gripped and the mouthpiece is pivoted relative to the mouthpiece. However, the grip 318 as found in Figs. 6 – 7 of Rand is located within the proximal end, since the proximal end may be considered to run from a center of the inhaler to its proximal most edge. The grip enables the inhaler to be firmly gripped or secured while the mouthpiece is pivoted relative to the housing, as illustrated in Figs. 6 -7 and described in c. 5: 26 – 27. It is also noted that Figs. 1 – 2 of Rand are fully capable of being grasped a proximal end while the mouthpiece is moved, or pivoted as claimed.
As such, examiner hereby maintains rejection of claims 1, 14, and dependents therein.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F.
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/BRADLEY H PHILIPS/ Primary Examiner, Art Unit 3799