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 .
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) 16-18, 20-23, 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parry-Billings et al. (US 2014/0158126 A1) in view of Turgeon et al. (WO 93/03785 A).
Regarding claim 16, Parry-Billings discloses a powder inhaler, comprising:
a casing (1, 2) having a mouthpiece (3) [0021]-[0025];
an inhalation channel (27) housed in the casing and connected to the mouthpiece [0021]-[0025];
a container (7) housed in the casing for storing a powdered medicament [0021]-[0025];
a metering device (figure 9) comprising a shuttle (15) having a dosing recess (18), wherein the shuttle is movable between a filling position, in which the dosing recess is in alignment with an opening of the container and faces said opening so as to be filled with a dose of the powdered medicament (figure 7a) [0023], and an inhalation position, in which the dosing recess is in alignment with the inhalation channel, for enabling inhalation of the dose of the powdered medicament contained in the dosing recess through the mouthpiece [0023].
Parry-Billings is not explicit in that the inhaler comprises a sealing device operationally active at a coupling zone of the shuttle with a container when the shuttle is in the filling position, said coupling zone circumscribing the dosing recess and the opening.
However, Turgeon teaches it is known for a powder inhaler (abstract) to comprise a sealing device (elastomeric sealing gaskets) operationally active at a coupling zone of the shuttle (30; the shuttle is sufficiently strong as per page 11, lines 8-13) with a container (11) when the shuttle is in the filling position (page 11, lines 22-25).
It would have been obvious to have modified Parry-Billings to include a sealing device operationally active at a coupling zone of the shuttle, which is made of a suitably strong material, with a container when the shuttle is in the filling position as taught by Turgeon for the purpose of preventing leakage or escape of powder from the reservoir (page 11, lines 24-25).
While Turgeon does not explicitly state said coupling zone circumscribing the dosing recess and the opening, Turgeon states the seal is between the container (11) and the shuttle (30) in order to prevent powder leakage (page 11, lines 24-25). There are a finite number of identified predictable solutions to this and those include a finite number of places the seal/s can be placed in order to prevent powder leakage. One of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success and one of those locations would be around the dosing recess (32 of Turgeon; 18 of Parry-Billings) and another would be around the opening of the reservoir (11 of Turgeon; 7 of Parry-Billings). Both of these locations circumscribe the dosing recess and the opening. The courts have held "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense.” and thus this sealing arrangement would have been obvious to try.
Regarding claim 17, Parry-Billings as modified further discloses wherein the shuttle (15) comprises a main part (ends of 15) and a dosing part (center of 15 where 18 is located);
the dosing part comprises the dosing recess (18);
the sealing device comprises a deformable portion surrounding the dosing recess and connecting the dosing part to the main part (as modified by Turgeon the seal is a sealing gasket around the dosing recess 18 and thus it is a deformable portion that surrounds the dosing recess 18 and connects 18 to the main part as it is between the recess and the main part);
the deformable portion (elastomeric sealing gasket; page 11, line 22 of Turgeon) is less stiff than the main part along a direction perpendicular to a lying plane of the shuttle (this is an inherent feature of an elastomeric sealing gasket and Turgeon states the material of the shuttle is sufficiently strong as per page 11, lines 8-13); and
at least one spring (17) is interposed between the casing and the dosing part and is configured to push said dosing part against the opening of the container by deforming the deformable portion when the shuttle is in the filling position [0118] (Parry-Billings as modified with the elastomeric sealing gasket of Turgeon would deform with pressure).
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Regarding claim 18, Parry-Billings further discloses wherein the shuttle is shaped as a plate and the main part has a first wall thickness, and the deformable portion has a second wall thickness equal to or smaller than the first wall thickness (the thickness is uniform as shown in figures 12, 13).
Regarding claim 20, Parry-Billings as modified does not expressly disclose wherein the deformable portion has an average width, and a ratio t2/way of the second wall thickness (t2) to the average width (way) is smaller than 0.4.
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 device of Parry-Billings to have a wherein the deformable portion has an average width, and a ratio t2/way of the second wall thickness (t2) to the average width (way) is smaller than 0.4 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 device of Parry-Billings would not operate differently with the claimed dimensions and would function appropriately having the claimed dimensions.
Regarding claim 21, Parry-Billings further discloses wherein the main part, the deformable portion and the dosing part are made in a single piece (as modified by Turgeon, the main part, the deformable portion and the dosing part are a single piece; see figure 9 for example). "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)
Regarding claim 22, Parry-Billings as modified further discloses wherein the deformable portion is made of or comprises an elastomeric material (page 11, lines 22 of Turgeon).
Regarding claim 23, Parry-Billings further discloses wherein the dosing part comprises at least one stiffening rib (28) on a side of the shuttle opposite the dosing recess (see figure 13).
Regarding claim 25, Parry-Billings further discloses wherein the at least one spring contacts the dosing part at least at a center of the dosing recess (middle region of 15 as per [0118]; figure 18, figure 13).
Regarding claim 26, Parry-Billings as modified further discloses wherein the sealing device comprises a gasket placed at the coupling zone, at least when the shuttle is in the filling position (as modified by Turgeon page 11, lines 24-25). MPEP 2125. The description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art. In re Wright, 569 F.2d 1124, 1127-28, 193 USPQ 332, 335-36 (CCPA 1977)
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parry-Billings et al. (US 2014/0158126 A1) in view of Turgeon et al. (WO 93/03785 A) in further view of Hetzer et al. (US 2009/0293868 A1).
Regarding claim 19, Parry-Billings as modified discloses the claimed invention substantially as set forth for claim 18 above but does not explicitly disclose wherein the dosing part comprises a peripheral stiffening rib surrounded by the deformable portion.
However, Hetzer teaches it is known to embed a gasket (44) into the surround material [0065] and as such this would create a central peripheral stiffening rib (the boundary defining the orifice comprising the material of 15 (Parry-Billings) which defines a groove for the sealing gasket of Turgeon thus creating a stiffening rib) (figure 5d).
It would have been obvious to one of ordinary skill in the art to have modified Parry-Billings wherein the dosing part comprises a peripheral stiffening rib surrounded by the deformable portion for the purpose of securely positioning the sealing element [0065].
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parry-Billings et al. (US 2014/0158126 A1) in view of Turgeon et al. (WO 93/03785 A) in further view of Zangerle (WO 2008/074441 A2)
Regarding claim 24, Parry-Billings as modified does not explicitly disclose wherein the shuttle comprises at least one connecting rib joining the main part to the dosing part.
However, Zangerle teaches a shuttle (300) comprising at least one connecting rib (307) joining the main part (left end of figure 9c) to the dosing part (portion around 320) (see figure 9c).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Parry-Billings such that the shuttle comprises at least one connecting rib joining the main part to the dosing part to create stop edges ensuring the shuttle moves appropriately (page 20, lines 22-23).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parry-Billings et al. (US 2014/0158126 A1) in view of Turgeon et al. (WO 93/03785 A) in further view of Howlett (GB 2,240,816 A)
Regarding claim 29, Parry-Billings as modified does not explicitly disclose the shape of the gasket and thus does not disclose wherein the gasket has a raised bead protruding towards the container and/or a raised bead protruding towards the shuttle.
However, Howlett teaches a shape of a gasket (see figure 9, 95 and 96).
It would have been obvious to have modified Parry-Billings such that the gasket is the shape shown in figure 9 of Howlett as this is a known shape for an o-ring seal.
As modified Parry-Billings discloses wherein the gasket has a raised bead protruding towards the container (if gasket is on shuttle (15) the rounded bead would protrude towards container (7)) and/or a raised bead protruding towards the shuttle (If gasket is on opening of container 7, the rounded part of the gasket would protrude towards shuttle 15).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parry-Billings et al. (US 2014/0158126 A1) in view of Turgeon et al. (WO 93/03785 A) in further view of Johnson (WO 02/30499 A2)
Regarding claim 30, Parry-Billings as modified does not explicitly disclose a desiccant chamber placed inside the casing and containing or configured to contain a desiccant, wherein the desiccant comprises molecular sieves.
However, Johnson teaches that it is known to place a dessicant chamber inside an inhaler casing (page 4, lines 12-16), wherein the desiccant comprises molecular sieves (page 4, lines 12-16).
It would have been obvious to have modified Parry-Billings to include a desiccant chamber placed inside the casing and containing or configured to contain a desiccant, wherein the desiccant comprises molecular sieves as taught by Johnson for the purpose of absorbing moisture (page 4, line 7) reducing moisture within the drug formulation (page 3, lines 26-28).
Allowable Subject Matter
Claims 27-28 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 prior art does not disclose nor suggest a support plate sandwiched between the container and the shuttle and having a through opening facing the opening of the container, wherein the gasket is placed around said through opening as required by claim 27. Claim 28 depends from claim 27 and thus also contains allowable subject matter.
Conclusion
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/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
