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 statements (IDS) submitted on 12/2/2022 and 2/2/2024 (2) have been considered by the examiner.
Claim Objections
Claims 2, 4, and 7 are objected to because of the following informalities:
regarding claim 2, examiner suggests the following amendment: “wherein the cap is [[a]] snap fit onto the cylinder”;
regarding claim 4, examiner suggests the following amendment: “A refill according to claim 1”;
regarding claim 7, examiner suggests the following amendment “inwardly projecting”.
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.
Claims 6 and 11 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 6 recites, “wherein the internal passage preferably has an elongate shape.” The term "preferably" renders the claim indefinite because it is unclear whether the limitation following the term is part of the claimed invention. See MPEP § 2173.05(d).
Claim 11 recites, “the inhaling end being dimensioned to fit within the internal passage in the refill, and the inhaling end being dimensioned so that it will not fit within the internal passage in the refill.” These two limitations are contradictory; therefore, it is unclear whether the inhaling end is intended to be dimensioned to fit, or not fit, within the internal passage in the refill.
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.
Claims 1, 4 – 6, 8 – 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Silcock (GB 2549769) in view of Wittersheim et al. (GB 1154268).
Regarding claim 1, Silcock discloses a refill for an inhaler (Figs. 1 and 2, “inhaler 100 has a first refill end 20” [page 8]; Figs. 4A and 4B, “refill container 34” [page 10]), the refill comprising
a cylinder with an axis and containing a pressurised inhalable composition (Figs. 4A and 4B, cylinder is “refill container 34” [page 10]; axis extends in vertical direction of Figs. 4A and 4B; “the invention relates to the design of the outlet configuration from a reservoir of pressurised composition” [page 1]), and
an outlet valve at one end (Figs. 4A and 4B, “outlet 32” [page 10], indicated to have a valve as follows: “In order to fill or refill the reservoir 64 of the inhaler 100, the refill end 20 of the inhaler 100 is pressed onto an outlet 32 of a refill container 34. The container outlet 32 passes through the central opening 30A of the end cap 30 and engages with the spigot 28. The force of the container outlet 32 on the spigot 28 overcomes the biasing force of the spring 24 and causes the valve member 26 and the annular member 29 located thereon to move away from the end cap 30 thus providing a flow path from the container outlet 32, through the grooves 28A of the spigot 28, between the annular member 29 and the end cap 30, around the valve member 26 through the apertures 25A in the cage 25 to the reservoir 64. Figure 4B illustrates this open position of the refill valve 22. In this manner the reservoir 64 can be filled or refilled via the refill valve 22” [page 10]; since a flow path from refill container 34 to reservoir 64 is only created when spigot 28 engages outlet 32, this indicates the presence of a valve in outlet 32, which prevents the contents of refill container 34 from escaping until spigot 28 engages outlet 32),
the outlet valve having a hollow valve stem extending axially from the cylinder (Figs. 4A and 4B show wherein outlet 32 is a hollow valve stem, indicated to be hollow to allow the contents of refill container 34 to flow to reservoir 64).
Silcock does not expressly disclose a cap fitted onto the cylinder at the outlet end, the cap extending axially beyond the valve stem, the cap having an internal passage extending through the cap to allow access to the valve stem, the internal passage providing a guide wall to guide the inhaler, in use, onto the stem during the refill process.
Wittersheim is directed to “storage vessels containing aerosol liquid” [page 1, lines 9-10]. Wittersheim discloses:
a cap fitted onto a cylinder at the outlet end (Fig. 1, cap 2 is fitted onto a cylinder / “storage vessel 1” [page 2, lines 38-39]),
the cap extending axially beyond the valve stem (Fig. 1, cap 2 extends axially beyond valve stem / “valve tube 6” [page 2, line 50]),
the cap having an internal passage (Fig. 1, internal passage / “central orifice 4” [page 2, line 46] extending through the cap to allow access to the valve stem (Fig. 1, valve stem 6),
the internal passage providing a guide wall (Fig. 1, guide wall / “member 7” [page 2, line 52—53], also referred to as “centering tube 7” [page 3, line 27] to guide the inhaler, in use, onto the stem during the refill process (Fig. 1, “valve dome 13” [page 3, lines 24-25] of rechargeable dispenser 3 [page 2, lines 40-42] (corresponding to the inhaler) is guided onto stem 6).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a cap fitted onto the cylinder at the outlet end, the cap extending axially beyond the valve stem, the cap having an internal passage extending through the cap to allow access to the valve stem, the internal passage providing a guide wall to guide the inhaler, in use, onto the stem during the refill process. This is a known structure for refilling a container, applied to a known device, to predictably allow the dispensing container to be refilled. Additionally, the use of a guide wall allows for correct alignment of the dispensing container with the refill container, to ensure proper refilling.
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Figs. 1 and 2 of Silcock
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Figs. 3A and 3B of Silcock
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Figs. 4A and 4B of Silcock
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Fig. 1 of Wittersheim
Regarding claim 4, Silcock / Wittersheim does not expressly disclose a sticker surrounding both the cap and the cylinder.
However, Silcock discloses a sticker / “label 90” [page 8] as follows: “inhaler 100 is formed of four sub-assemblies namely a mouthpiece 42, a composition chamber 62, a refill valve 22 and a label 90. The composition chamber 62 is provided between the mouthpiece 42 and the refill valve 22. The label 90 is wrapped around the assembled mouthpiece 42, composition chamber 62 and refill valve 22. Each of the sub-assemblies and their operation are described in detail below. As illustrated in Figure 2 the inhaler device 100 is formed of a housing 1 in the form of a main body 2 and a closure member 3. The closure member 3 is held in place on the housing 1 by the label 90” [page 8].
In the combination of the cap and cylinder of Silcock / Wittersheim, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a sticker surrounding both the cap and the cylinder. This would allow for holding the cap and cylinder in place.
Regarding claim 5, Silcock / Wittersheim does not expressly disclose wherein the internal passage extending through the cap has a non-circular cross-section.
However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the internal passage extending through the cap has a non-circular cross-section. The courts have held that a change in shape alone, without demonstration of the criticality of a specific limitation, may be considered obvious to a person of ordinary skill in the art. MPEP § 2144.04-IV-B.
Regarding claim 6, Silcock does not expressly disclose wherein the internal passage preferably has an elongate shape.
Wittersheim discloses wherein the internal passage preferably has an elongate shape (Fig. 1 shows wherein internal passage / “central orifice 4 has an elongate shape).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the internal passage preferably has an elongate shape. The internal passage, along with its guide wall, allows for correct alignment of the dispensing container with the refill container, to ensure proper refilling.
Regarding claim 8, Silcock does not expressly disclose wherein the cross sectional area of the internal passage in a plane perpendicular to the axial direction is at least 30% of the cross sectional area of the cap in a plane perpendicular to the axial direction.
While Fig. 1 of Wittersheim shows the cross sectional area of the internal passage in a plane perpendicular to the axial direction and the cross sectional area of the cap in a plane perpendicular to the axial direction, Wittersheim does not expressly disclose wherein the cross sectional area of the internal passage in a plane perpendicular to the axial direction is at least 30% of the cross sectional area of the cap in a plane perpendicular to the axial direction.
However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the cross sectional area of the internal passage in a plane perpendicular to the axial direction is at least 30% of the cross sectional area of the cap in a plane perpendicular to the axial direction, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP § 2144.05-II-A.
Regarding claim 9, Silcock does not expressly disclose wherein the cross sectional area of the internal passage in a plane perpendicular to the axial direction is at least 40% of the cross sectional area of the cap in a plane perpendicular to the axial direction.
While Fig. 1 of Wittersheim shows the cross sectional area of the internal passage in a plane perpendicular to the axial direction and the cross sectional area of the cap in a plane perpendicular to the axial direction, Wittersheim does not expressly disclose wherein the cross sectional area of the internal passage in a plane perpendicular to the axial direction is at least 40% of the cross sectional area of the cap in a plane perpendicular to the axial direction.
However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the cross sectional area of the internal passage in a plane perpendicular to the axial direction is at least 40% of the cross sectional area of the cap in a plane perpendicular to the axial direction, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP § 2144.05-II-A.
Regarding claim 11, Silcock / Wittersheim disclose the refill according to claim 1 as described in the rejection of claim 1. Silcock further discloses a refill in combination with an inhaler (Fig. 1, “inhaler 100” [page 8]), the inhaler having a housing with a refill end and an inhaling end (Fig. 1, “refill end 20” and inhaling end / “mouthpiece end 40” [page 8]). Silcock further discloses an internal passage in refill 34 (which can be considered an internal passage of stem 32). The inhaling end / mouthpiece end 40 is dimensioned so that it will not fit within the internal passage in the refill, as shown in Figs. 1, 4A, and 4B. Please see also the 112(b) rejection of claim 11.
Claims 2 – 3 are rejected under 35 U.S.C. 103 as being unpatentable over Silcock (GB 2549769) in view of Wittersheim et al. (GB 1154268), further in view of Rowland et al. (US 2018/0200459).
Regarding claim 2, Silcock / Wittersheim does not expressly disclose wherein the cap is snap fit onto the cylinder.
Rowland is directed to an inhaler [Title]. Rowland discloses wherein a refill / cap is snap fit onto an inhaler (“FIG. 13 shows an inhaler device according to an embodiment of the invention comprising a storage chamber movably connected to the base end of the elongated body for holding an inhalable liquid storage container in the form of an ampoule (FIG. 13A) and an enlarged view of the storage chamber comprising an unopened ampoule in a first position and movable to a second position to open the liquid storage container by snapping or similar (FIG. 13B)” [0056]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the cap is snap fit onto the cylinder. This is a known means for attaching two elements together, applied to a known device, to predictably allow for the attachment of the cap to the cylinder.
Regarding claim 3, Silcock / Wittersheim does not expressly disclose wherein a film is applied across the top of the cap to cover the internal passage.
Rowland discloses wherein a film is applied to an element to cover an internal passage (“The type of liquid storage container will determine how it may be opened to deliver or release the inhalable liquid onto the passive evaporation support material. For example, a vial with a screw cap lid may be opened by unscrewing the lid, a vial with a plug may be opened by unplugging i.e. by pulling out the plug or pushing it into the vial, a vial sealed with a vapour impermeable film may be opened by puncturing or piercing the film” [0100]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein a film is applied across the top of the cap to cover the internal passage. This prevents the contents of the cap from being released until desired.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Silcock (GB 2549769) in view of Wittersheim et al. (GB 1154268), further in view of Spohn et al. (US 2008/0086087).
Regarding claim 7, Silcock / Wittersheim does not expressly disclose wherein the internal passage has at least one inwardly protecting axially extending rib to provide a location feature with a corresponding recess on the refill end of the inhaler.
Spohn is directed to a fluid deliver system [Abstract]. Spohn discloses an internal passage comprising at least one inwardly projecting axially extending rib (Fig. 30, rib / projection 1528 [0253]) to provide a location feature with a corresponding recess (Fig. 30, recess 1520 [0253]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the internal passage has at least one inwardly protecting axially extending rib to provide a location feature with a corresponding recess on the refill end of the inhaler. A rib and corresponding recess advantageously allow for securing two elements together as desired.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Silcock (GB 2549769) in view of Wittersheim et al. (GB 1154268), further in view of Price et al. (US 2006/0213514).
Regarding claim 10, Silcock / Wittersheim does not expressly disclose wherein the valve stem is depressible axially to open the valve.
Price is directed to an aerosol delivery device [Abstract]. Price discloses wherein a valve stem is depressible axially to open a valve (“propellant canister 53 is a conventional unit which has a metering valve with a protruding valve stem, which when depressed releases propellant through a passage way in the valve stem” [0073]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wherein the valve stem is depressible axially to open the valve. This is a known means for opening a valve, applied to a known device, to achieve predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH KERR whose telephone number is (571)272-3073. The examiner can normally be reached M - F, 8:30 AM - 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Steven Crabb can be reached at 571-270-5095. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELIZABETH M KERR/Primary Examiner, Art Unit 3761