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 .
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, 2, and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of copending Application No. 19/211,644 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/211,644.
Regarding application claim 1, copending Application No. 19/211,644 (US Pub 20260034317) discloses
a spin chamber for use in an inhaler, the spin chamber comprising: (copending claim 1, lines 1-2),
a primary recess configured to receive air to mix with contents of a capsule the primary recess having a curved wall configured to allow rotation of the capsule (copending claim 1, lines 3-5);
a secondary recess configured to hold the capsule, the secondary recess located within a bottom surface of the primary recess (copending claim 1, lines 6-8); and
at least one curved inlet channel configured to allow air to travel therethrough, the at least one curved inlet channel defining a curved recess and comprising a tangential section and a funnel section (copending claim 1, lines 9-12),
wherein:
at least a portion of the tangential section is substantially tangential to the curved wall of the primary recess (copending claim 1, lines 13-16);
the tangential section is connected at a first end to an air inlet on an exterior surface of the spin chamber and at a second end to a first end of the funnel section, wherein the air inlet is configured to allow air to enter therethrough into the spin chamber (copending claim 1, lines 17-21); and
the funnel section curves toward the primary recess and is connected at a second end to an entry point configured to allow air to enter therethrough into the primary recess, wherein the funnel section is downstream from the tangential section (copending claim 1, lines 22-26);
wherein the curved inlet channel is separated from the primary recess along a majority of its length by the curved wall of the primary recess (copending claim 1, lines 27-29).
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 53 of copending Application No. 19/211,644.
Regarding application claim 1, copending Application No. 19/211,644 (US Pub 20260034317) discloses
a spin chamber for use in an inhaler, the spin chamber comprising: (copending claim 53, lines 2-3),
a primary recess configured to receive air to mix with contents of a capsule the primary recess having a curved wall configured to allow rotation of the capsule (copending claim 53, lines 4-7);
a secondary recess configured to hold the capsule, the secondary recess located within a bottom surface of the primary recess (copending claim 53, lines 8-10); and
at least one curved inlet channel configured to allow air to travel therethrough, the at least one curved inlet channel defining a curved recess and comprising a tangential section and a funnel section (copending claim 53, lines 11-14),
wherein:
at least a portion of the tangential section is substantially tangential to the curved wall of the primary recess (copending claim 53, lines 15-18);
the tangential section is connected at a first end to an air inlet on an exterior surface of the spin chamber and at a second end to a first end of the funnel section, wherein the air inlet is configured to allow air to enter therethrough into the spin chamber (copending claim 53, lines 19-24); and
the funnel section curves toward the primary recess and is connected at a second end to an entry point configured to allow air to enter therethrough into the primary recess, wherein the funnel section is downstream from the tangential section (copending claim 53, lines 25-30);
wherein the curved inlet channel is separated from the primary recess along a majority of its length by the curved wall of the primary recess (copending claim 53, lines 31-33).
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 19/211,644.
Regarding application claim 2, copending Application No. 19/211,644 (US Pub 20260034317) discloses
the spin chamber of claim 1 (see claim 1 above),
wherein: the spin chamber has a longitudinal axis extending from a top of the spin chamber, down through the primary and secondary recesses, to a bottom of the spin chamber (copending claim 2, lines 2-5);
the spin chamber comprises a top surface located at the top of the spin chamber with respect to the longitudinal axis (copending claim 2, lines 6-8);
the primary recess is proximate to the top of the spin chamber along the longitudinal axis, and the secondary recess is proximate to the bottom of the spin chamber along the longitudinal axis (copending claim 2, lines 9-12);
the bottom surface of the primary recess faces the top of the inhaler with respect to the longitudinal axis (copending claim 2, lines 13-14); and
the spin chamber is configured so that in use air flows in from the air inlet, through the at least one curved inlet channel, through the primary recess and out through an outlet of the inhaler (copending claim 2, lines 15-18).
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/211,644.
Regarding application claim 17, copending Application No. 19/211,644 (US Pub 20260034317) discloses
an inhaler comprising: a spin chamber, wherein the spin chamber comprises: (copending claim 1, lines 1-2)
a primary recess configured to receive air to mix with contents of a capsule, the primary recess having a curved wall configured to allow rotation of the capsule (copending claim 1, lines 3-5);
a secondary recess configured to hold the capsule, the secondary recess located within a bottom surface of the primary recess; (copending claim 1, lines 6-8) and
at least one curved inlet channel configured to allow air travel therethrough, the at least one curved inlet channel defining a curved recess and comprising a tangential section and a funnel section (copending claim 1, lines 9-12),
wherein: at least a portion of the tangential section is substantially tangential to the curved wall of the primary recess (copending claim 1, lines 13-16);
the tangential section is connected at a first end to an air inlet on an exterior surface of the spin chamber and at a second end to a first end of the funnel section, wherein the air inlet is configured to allow air to enter therethrough into the spin chamber (copending claim 1, lines 17-21); and
the funnel section curves in toward the primary recess and is connected at a second end to an entry point configured to allow air enter therethrough into the primary recess, wherein the funnel section is downstream from the tangential section (copending claim 1, lines 22-26);
wherein the curved inlet channel is separated from the primary recess along a majority of its length by the curved wall of the primary recess (copending claim 1, lines 27-29).
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 53 of copending Application No. 19/211,644.
Regarding application claim 17, copending Application No. 19/211,644 (US Pub 20260034317) discloses
an inhaler comprising: a spin chamber for use in an inhaler, the spin chamber comprising: (copending claim 53, lines 2-3),
a primary recess configured to receive air to mix with contents of a capsule the primary recess having a curved wall configured to allow rotation of the capsule (copending claim 53, lines 4-7);
a secondary recess configured to hold the capsule, the secondary recess located within a bottom surface of the primary recess (copending claim 53, lines 8-10); and
at least one curved inlet channel configured to allow air to travel therethrough, the at least one curved inlet channel defining a curved recess and comprising a tangential section and a funnel section (copending claim 53, lines 11-14),
wherein:
at least a portion of the tangential section is substantially tangential to the curved wall of the primary recess (copending claim 53, lines 15-18);
the tangential section is connected at a first end to an air inlet on an exterior surface of the spin chamber and at a second end to a first end of the funnel section, wherein the air inlet is configured to allow air to enter therethrough into the spin chamber (copending claim 53, lines 19-24); and
the funnel section curves toward the primary recess and is connected at a second end to an entry point configured to allow air to enter therethrough into the primary recess, wherein the funnel section is downstream from the tangential section (copending claim 53, lines 25-30);
wherein the curved inlet channel is separated from the primary recess along a majority of its length by the curved wall of the primary recess (copending claim 53, lines 31-33).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Objections
Claims objected to because of the following informalities:
Claim 2, line 9, “the top of the inhaler” should read “a top of the inhaler”
Claim 17, line 2, “the the spin chamber” should read “the spin chamber”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-7, 9-11, 13, and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over O’Flaherty (US 20220305222) in view of Di Castri (US 20240042147).
Regarding claim 1, O'Flaherty discloses
a spin chamber (figs. 4-8; body 1050 comprises composition receptable 1300, the vortex chamber 1500 and chamber channels 1520; [0097]-[0141] for use in an inhaler (figs. 4-8; device 1000 is used as an inhaler device; [0116] and [0118]),
the spin chamber comprising:
a primary recess (vortex chamber 1500) configured to receive air to mix with contents of a capsule, the primary recess having a curved wall configured to allow rotation of the capsule (figs. 4-8; the entering gas flow into vortex chamber 1500 is forced into a substantially circular, circulating or vortex pathway. The effect of this is that the container of composition, which has been displaced into the vortex chamber 1500 is caused to spin rapidly; [0106]-[0107])
a secondary recess configured to hold the capsule (figs. 4-8; a container of composition (capsule) is seated within the composition receptacle 1300, the receptacle acts to hold the container in place; [0100]),
the secondary recess located within a bottom surface of the primary recess (see figs. 4-8 and [0136]-[0138]; the composition receptacle 1300 is located within a bottom surface of the vortex chamber 1500); and
at least one curved inlet channel configured to allow air to travel therethrough, the at least one curved inlet channel defining a curved recess and comprising a tangential section and a downstream section (see figs. 4 and 8; each of the chamber channels 1520 define a curved recess that allows air to travel through to the vortex chamber 1500; [0106]-[0107]; and can comprises a tangential section and downstream section, see modified fig. 8 below),
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wherein: at least a portion of the tangential section is substantially tangential to the curved wall of the primary recess (see figs. 6b-8 and modified fig. 8 above; the upstream tangential section of the chamber channel 1520 is tangential to the curved walls 1510 of the vortex chamber 1500; [0106]-[0107] and [0134]);
the tangential section is connected at a first end to an air inlet on an exterior surface of the spin chamber (see figs. 6b-8 and modified fig. 8 above; upper end of the tangential sections of the chamber channels 1520 are connected to the chamber ports 1530 that are positioned at an exterior surface to the vortex chamber 1500; [0106]-[0107]) and at a second end to a first end of the downstream section (see figs. 6b-8 and modified fig. 8 above; lower end of the tangential sections of the chamber channels 1520 connects/flows into upper end of downstream sections of the chamber channels 1520),
wherein the air inlet is configured to allow air to enter therethrough into the spin chamber (figs. 4-8; chamber ports 1530 are continuous with chamber channels 1520 such that the entering gas flow is forced into a substantially circular, circulating or vortex pathway into the vortex chamber 1500; [0106]-[0107]); and
the downstream is connected at a second end to an entry point configured to allow air to enter therethrough into the primary recess (see modified fig. 8 above; lower end of downstream sections of chamber channels 1520 connect to an entry point which allows air to circulate into the vortex chamber 1500; [0106]-[0107]),
wherein the downstream section is downstream from the tangential section (see modified fig. 8 above; tangential section is upstream to the downstream section of the chamber channels 1520);
wherein the curved inlet channel is separated from the primary recess along a majority of its length by the curved wall of the primary recess (see figs. 4-8 and modified fig. 8 above; the chamber channels 1520 are separated along the majority of its length by the curved wall 1510 of the vortex chamber 1500; [0106]-[0107], [0134]).
While O'Flaherty discloses the curved chamber channels 1520 which can comprise upstream and downstream sections (see modified fig. 8 above); the downstream section is, however, not a funnel section, as it comprises an outer wall with straight sections. Therefore, O'Flaherty does not disclose at least one curved inlet channel defining a funnel section; the funnel section curves toward the primary recess.
Di Castri discloses an analogous inhaler with a vortex chamber 26 (abstract and [0121-[0148]) with
at least one curved inlet channel defining a funnel section and the funnel section curves toward the primary recess (figs. 2b-5b and see modified fig. 10 below; curved inlet channels extending from hollows 35 (tangential sections) to the funnel sections downstream of 34 which curve towards the vortex chamber 26; [0127]-[0135]).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the chamber channels of O'Flaherty with the curved inlet channels that has a funnel section as disclosed in Di Castri to allow collecting all the powdered medicament/ensure a complete emptying from the dosing recess, delimit the vortex chamber to generate a cyclonic airflow resulting in a strong velocity gradient, and to route said powdered medicament into the inhalation channel (Di Castri: [0121] and [0148]).
Regarding claim 2, O'Flaherty further discloses
the spin chamber (O'Flaherty: spin chamber (device 1000); Di Castri: shape/position of channels and vortex chamber) of claim 1,
wherein: the spin chamber has a longitudinal axis extending from a top of the spin chamber, down through the primary and secondary recesses, to a bottom of the spin chamber (see modified fig. 4 below which shows the longitudinal axis extending from the top of the device 1000 through the body 1050 (comprises the vortex chamber 1500, receptable 1300, and channels 1520) to the bottom of the device 100; [0044], [0098], [0106]-[0107]; also see figs. 5b and 6b-8);
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the spin chamber comprises a top surface located at the top of the spin chamber with respect to the longitudinal axis (see modified fig. 4 above and fig. 8; top surface of body 1050/wall 1520 is located at the top of the body longitudinally);
the primary recess is proximate to the top of the spin chamber along the longitudinal axis (see modified fig. 4 above and figs. 5b and 6b-8; the vortex chamber 1500 is located proximate to the top of the body 1050), and
the secondary recess is proximate to the bottom of the spin chamber along the longitudinal axis (see modified fig. 4 above and figs. 5b and 6b-8; the composition receptacle 1300 is located proximate to the bottom of the body 1050);
the bottom surface of the primary recess faces the top of the inhaler with respect to the longitudinal axis (see modified fig. 4 above and figs. 5b and 6b-8; the bottom surface of the vortex chamber 1500 faces towards the top of the inhaler device 1000); and
the spin chamber is configured so that in use air flows in from the air inlet, through the at least one curved inlet channel (figs. 4-8; air flows from gas inlet 1100 into body 1050 through an upper end of the chamber ports 1530 which are continuous with chamber channels 1520; [0106]-[0107]), through the primary recess (figs. 4-8; the gas flow is then circulated as a vortex into the vortex chamber 1500; [0106]-[01507]) and out through an outlet of the inhaler (figs. 4-8; the gas flows with entrained composition then passes through into the gas outlet 1200, [0106]-[0107] in the manner previously described for device 10, [0067] and [0088]-[0090]).
Regarding claim 3, the modified device of O'Flaherty further discloses
the spin chamber (O'Flaherty: spin chamber (device 1000); Di Castri: shape/position of channels and vortex chamber) of claim 2,
wherein the tangential section comprises a first portion and a second portion (O'Flaherty: see modified fig. 8 above in claim 1, the tangential section can comprise a first and second portion),
wherein: the first portion extends from the first end of the tangential section to a point between the first end and the second end of the tangential section (O'Flaherty: see modified fig. 8 above in claim 1 and Di Castri: see modified fig. 10 above in claim 1);
the second portion extends from the point between the first end and the second end of the tangential section to the second end of the tangential section (O'Flaherty: see modified fig. 8 above in claim 1 and Di Castri: see modified fig. 10 above in claim 1);
the second portion is downstream from the first portion (O'Flaherty: see modified fig. 8 above in claim 1 and Di Castri: see modified fig. 10 above in claim 1; the second portion of the tangential sections as labelled are downstream from the first portion of the tangential sections);
the first portion is widest near the air inlet (O’Flaherty: see modified fig. 8 above; the portion of the tangential sections of the chamber channels 1520 closest to the chamber ports 1530 (air inlets) are the widest; Di Castri: see modified fig. 10 above in claim 1); and
the second portion is of a substantially uniform width (O'Flaherty: see modified fig. 8 above in claim 1 and Di Castri: see modified fig. 10 above in claim 1; the second portion of the tangential portion is substantially uniform in width).
Regarding claim 4, the modified device of O'Flaherty further discloses
the spin chamber (O'Flaherty: spin chamber (device 1000); Di Castri: shape/position of channels and vortex chamber) of claim 3,
wherein the at least one curved inlet channel comprises an inner wall and an outer wall (O'Flaherty: figs. 4-8; chamber channels 1520 are formed by the outer walls of the body 1050 and the curved walls 1510 of the vortex chamber 1500; [0106]-[0107]; Di Castri: see modified fig. 10 above; the curved inlet channels are formed from outer walls 29 and inner curved walls 31; [0127]-[0135]),
wherein: the inner wall substantially follows an outline of the primary recess (O'Flaherty: figs. 4-8; the curved walls 1510 follow the outline of the vortex chamber 1500; [0106]-[0107]; Di Castri: fig. 10; the two curved walls 31 follow the outline of the vortex chamber diameter d; [0127]-[0135]);
the inner wall extends along an entirety of the tangential section (O'Flaherty: figs. 4-8; the curved walls 1510 extend along the entirety of the tangential section of the chamber channels 1520; [0106]-[0107]; Di Castri: see modified fig. 10 above; the two curved walls 31 extend along the entirety of the tangential section of hollows 35; [0127]-[0135]) and along at least a portion of the funnel section (Di Castri: see modified fig. 10 above; the two curved walls 31 extend along a small portion of the corresponding funnel section and along the length of the opposing funnel section; [0127]-[0135]); and
the outer wall is substantially straight in the first portion of the tangential section of the at least one curved inlet channel (Di Castri: see modified fig. 10 above; the outer wall 29 of the first portion of the tangential section of the hollow 35 is substantially straight).
Regarding claim 5, O'Flaherty further discloses
the spin chamber (O'Flaherty: spin chamber (device 1000); Di Castri: shape/position of channels and vortex chamber) of claim 2,
wherein the primary recess is substantially cylindrical (see figs. 4, 7, and 8; vortex chamber 1500 is cylindrically shaped).
Regarding claim 6, O'Flaherty further discloses
the spin chamber (O'Flaherty: spin chamber (device 1000); Di Castri: shape/position of channels and vortex chamber) of claim 2,
wherein the secondary recess is substantially obround-shaped with a length that is greater than its width such that the secondary recess is configured to receive a capsule horizontally relative to the longitudinal axis (see figs. 6b, 8, and 10b; composition receptacle 1300 is shaped to seat a container of composition (capsule) horizontally relative to the longitudinal axis; such that the receptacle is an obround-shape that has a length greater than its width; [0100]).
Regarding claim 7, the modified device of O'Flaherty further discloses
the spin chamber (O'Flaherty: spin chamber (device 1000); Di Castri: shape/position of channels and vortex chamber) of claim 2,
wherein the at least one curved inlet channel has a length that is greater than a radius of the primary recess (O'Flaherty: chamber channels 1520 substantially conform to the walls of the body 1050; [0107], see fig. 8; the channels 1520 extend the majority of the length of the diameter of the vortex chamber 1500; Di Castri: figs. 5a-5b and 10; the hollows 35 extends a length greater than the diameter d of the vortex chamber 26; [0129]).
Regarding claim 9, O'Flaherty further discloses
the spin chamber (O'Flaherty: spin chamber (device 1000); Di Castri: shape/position of channels and vortex chamber) of claim 2,
wherein the at least one curved inlet channel comprises two curved inlet channels (see figs. 4 and 8 which shows chamber channels 1520 comprising two curved chamber channels 1520; [0106]-[0107]; an upper end of the chamber ports 1530 are continuous with chamber channels 1520 and it will be appreciated there may be only one chamber port 1530 but at least two are optimal).
Regarding claim 10, O'Flaherty further discloses
the spin chamber (O'Flaherty: spin chamber (device 1000); Di Castri: shape/position of channels and vortex chamber) of claim 9,
wherein the two curved inlet channels are disposed on opposing sides of the primary recess (see figs. 4 and 8, chamber channels 1520 which substantially conform to the walls of the body 1050 such that the entering gas flow is forced into a substantially circular, circulating or vortex pathway into the vortex chamber 1500; [0106]-[0107]; the channels 1520 are formed on opposing sides of the vortex chamber 1500).
Regarding claim 11, the modified device of O'Flaherty further discloses
the spin chamber (O'Flaherty: spin chamber (device 1000); Di Castri: shape/position of channels and vortex chamber) of claim 10,
wherein the tangential sections of each opposing curved inlet channel are opposite each other across the primary recess (O'Flaherty: figs. 4-8; chamber channels 1520 which substantially conform to the walls of the body 1050 such that the entering gas flow is forced into a substantially circular, circulating or vortex pathway into the vortex chamber 1500; [0106]-[0107]; the channels 1520 are formed on opposing sides of the vortex chamber 1500), and
wherein the funnel sections of each opposing curved inlet channel are opposite each other across the primary recess (O'Flaherty: figs. 4-8; the chamber channels 1520 which include downstream sections are formed on opposing sides of the vortex chamber 1500; Di Castri: see modified fig 10 above in claim 1, funnel sections of the curved inlet channels (hollows 35) are formed on opposite sides; two air inlets 34 are placed on opposite sides of the vortex chamber and along tangential or substantially tangential inflow directions to form an air vortex in said vortex chamber 26; [0130]).
Regarding claim 13, O'Flaherty further discloses
the spin chamber (O'Flaherty: spin chamber (device 1000); Di Castri: shape/position of channels and vortex chamber) of claim 9,
wherein a cross-sectional area of the air inlet of a first of the two curved inlet channels is substantially equal to a cross-sectional area of the air inlet of a second of the two curved inlet channels (figs. 4, 5b, 6b-8; the chamber channels 1520 are substantially equal in size/dimensions as seen in figs. 6b-8; therefore, the cross-sectional area of the left chamber channel 1520 is substantially equal to the cross-sectional area of the right chamber channel 1520).
Regarding claim 15, the modified device of O'Flaherty further discloses
the spin chamber (O'Flaherty: spin chamber (device 1000); Di Castri: shape/position of channels and vortex chamber) of claim 2,
wherein a bottom surface of the at least one curved inlet channel is substantially level with the bottom surface of the primary recess with respect to the longitudinal axis (Di Castri: see figs. 2a-2c; hollows (curved channels) 35 are substantially level with the bottom surface of the vortex chamber 26; figs. 4-5b, and 10).
Regarding claim 16, O'Flaherty further discloses
the spin chamber (O'Flaherty: spin chamber (device 1000); Di Castri: shape/position of channels and vortex chamber) of claim 2,
wherein the primary recess extends downwards from the top surface of the spin chamber along the longitudinal axis (see modified fig. 8 below; the vortex chamber 1500 extends downwards from the top surface of the body 1050), and
the at least one curved inlet channel defines a curved recess extending downwards from the top surface of the spin chamber (see modified fig. 8 below; the chamber channels 1520 [0106]-[0107], define a curved recess that extends downward from the top surface of body 1050).
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Regarding claim 17, O'Flaherty discloses
an inhaler (figs. 4-8; device 1000 is used as an inhaler device; [0116] and [0118]) comprising:
a spin chamber (figs. 4-8; body 1050 comprises composition receptable 1300, the vortex chamber 1500 and chamber channels 1520; [0097]-[0141]) wherein the spin chamber comprises:
a primary recess (vortex chamber 1500) configured to receive air to mix with contents of a capsule, the primary recess having a curved wall configured to allow rotation of the capsule (figs. 4-8; the entering gas flow into vortex chamber 1500 is forced into a substantially circular, circulating or vortex pathway. The effect of this is that the container of composition, which has been displaced into the vortex chamber 1500 is caused to spin rapidly; [0106]-[0107])
a secondary recess configured to hold the capsule (figs. 4-8; a container of composition (capsule) is seated within the composition receptacle 1300, the receptacle acts to hold the container in place; [0100]),
the secondary recess located within a bottom surface of the primary recess (see figs. 4-8 and [0136]-[0138]; the composition receptacle 1300 is located within a bottom surface of the vortex chamber 1500); and
at least one curved inlet channel configured to allow air to travel therethrough, the at least one curved inlet channel defining a curved recess and comprising a tangential section and a downstream section (see figs. 4 and 8; each of the chamber channels 1520 define a curved recess that allows air to travel through to the vortex chamber 1500; [0106]-[0107]; and can comprises a tangential section and downstream section, see modified fig. 8 below),
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wherein: at least a portion of the tangential section is substantially tangential to the curved wall of the primary recess (see figs. 6b-8 and modified fig. 8 above; the upstream tangential section of the chamber channel 1520 is tangential to the curved walls 1510 of the vortex chamber 1500; [0106]-[0107] and [0134]);
the tangential section is connected at a first end to an air inlet on an exterior surface of the spin chamber (see figs. 6b-8 and modified fig. 8 above; upper end of the tangential sections of the chamber channels 1520 are connected to the chamber ports 1530 that are positioned at an exterior surface to the vortex chamber 1500; [0106]-[0107]) and at a second end to a first end of the downstream section (see figs. 6b-8 and modified fig. 8 above; lower end of the tangential sections of the chamber channels 1520 connects/flows into upper end of downstream sections of the chamber channels 1520),
wherein the air inlet is configured to allow air to enter therethrough into the spin chamber (figs. 4-8; chamber ports 1530 are continuous with chamber channels 1520 such that the entering gas flow is forced into a substantially circular, circulating or vortex pathway into the vortex chamber 1500; [0106]-[0107]); and
the downstream is connected at a second end to an entry point configured to allow air to enter therethrough into the primary recess (see modified fig. 8 above; lower end of downstream sections of chamber channels 1520 connect to an entry point which allows air to circulate into the vortex chamber 1500; [0106]-[0107]),
wherein the downstream section is downstream from the tangential section (see modified fig. 8 above; tangential section is upstream to the downstream section of the chamber channels 1520);
wherein the curved inlet channel is separated from the primary recess along a majority of its length by the curved wall of the primary recess (see figs. 4-8 and modified fig. 8 above; the chamber channels 1520 are separated along the majority of its length by the curved wall 1510 of the vortex chamber 1500; [0106]-[0107], [0134]).
While O'Flaherty discloses the curved chamber channels 1520 which can comprise upstream and downstream sections (see modified fig. 8 above); the downstream section is, however, not a funnel section, as it comprises an outer wall with straight sections. Therefore, O'Flaherty does not disclose at least one curved inlet channel defining a funnel section; the funnel section curves toward the primary recess.
Di Castri discloses an analogous inhaler with a vortex chamber 26 (abstract and [0121-[0148]) with
at least one curved inlet channel defining a funnel section and the funnel section curves toward the primary recess (figs. 2b-5b and see modified fig. 10 below; curved inlet channels extending from hollows 35 (tangential sections) to the funnel sections downstream of 34 which curve towards the vortex chamber 26; [0127]-[0135]).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the chamber channels of O'Flaherty with the curved inlet channels that has a funnel section as disclosed in Di Castri to allow collecting all the powdered medicament/ensure a complete emptying from the dosing recess, delimit the vortex chamber to generate a cyclonic airflow resulting in a strong velocity gradient, and to route said powdered medicament into the inhalation channel (Di Castri: [0121] and [0148]).
Regarding claim 18, O'Flaherty further discloses
the inhaler (O'Flaherty: spin chamber (device 1000); Di Castri: shape/position of channels and vortex chamber) of claim 17,
wherein the inhaler is configured so that in use air flows in from the air inlet, through the at least one curved inlet channel (figs. 4-8; air flows from gas inlet 1100 into body 1050 through an upper end of the chamber ports 1530 which are continuous with chamber channels 1520; [0106]-[0107]), through the primary recess (figs. 4-8; the gas flow is then circulated as a vortex into the vortex chamber 1500; [0106]-[01507]) and out through an outlet of the inhaler (figs. 4-8; the gas flows with entrained composition then passes through into the gas outlet 1200, [0106]-[0107] in the manner previously described for device 10, [0067] and [0088]-[0090]).
Regarding claim 19, O'Flaherty further discloses
the inhaler (O'Flaherty: spin chamber (device 1000); Di Castri: shape/position of channels and vortex chamber) of claim 18,
wherein the outlet of the inhaler comprises a mouthpiece (figs. 4-8; device 1000 are used as an inhaler device, the subject can use gas outlet 200/1200 as a mouthpiece, and inhale directly through gas outlet 200/1200. Alternatively, gas outlet 200/1200 can be used to connect suitable respiratory equipment; [0118]-[0119]).
Claims 8 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over O’Flaherty (US 20220305222) in view of Di Castri (US 20240042147) and further in view of Esteve (WO 2013016787).
Regarding claim 8, the modified device of O'Flaherty discloses
the spin chamber (O'Flaherty: spin chamber (device 1000); Di Castri: shape/position of channels and vortex chamber) of claim 2,
The modified device of O'Flaherty does not disclose wherein the top surface of the spin chamber is curved in a convex manner such that a depth along the longitudinal axis of the at least one curved inlet channel varies along its length.
Esteve discloses an analogous inhaler using a capsule and a chamber with a vortex
wherein the top surface of the spin chamber is curved in a convex manner such that a depth along the longitudinal axis of the at least one curved inlet channel varies along its length (see figs. 26-29; the top surface of the breakdown chamber 29 is rounded (in a convex manner) and intake points 28 also runs downwards from the top of the edge of the capsule receptacle 2 (creating a varied depth in the intake point/inlet channel); page 9, lines 4-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wall of the body and chamber channels of O’Flaherty with the modified construction of the air intake points and rounded wall as disclosed in Esteve to produce a desired restrictive effect that enhances the air flow control and consequently comprises a fine-tuned adjustment to the inhalatory resistance and ensuring a more stable air flow during inhalation, and the means for achieving specific pulmonary deposition profiles (Esteve: page 9, lines 4-26).
Regarding claim 14, the modified device of O'Flaherty discloses
the spin chamber (O'Flaherty: spin chamber (device 1000); Di Castri: shape/position of channels and vortex chamber) of claim 2,
The modified device of O'Flaherty does not explicitly disclose wherein the at least one curved inlet channel is configured such that in use air feeds into the primary recess, thereby causing the capsule to be lifted out of the secondary recess and to spin in the primary recess.
However, Esteve discloses analogous inhaler using a capsule and a chamber with a vortex
wherein the at least one curved inlet channel is configured such that in use air feeds into the primary recess, thereby causing the capsule to be lifted out of the secondary recess and to spin in the primary recess (see fig. 5; the intake points 11, 12 are configured to feed air into the breakdown chamber 10 creating a vortex effect that causes an outflow from the capsule C in its cradle 3 moving it to spin horizontally inside the breakdown chamber 10; page 11, lines 6-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vortex chamber, composition receptacle, and body of O’Flaherty with the intake points, breakdown chamber, and cradle as disclosed in Esteve to create a vortex effect that causes an outflow from the capsule (C) which allows for the capsule to spin yet still be restricted in a horizonal position; therefore, yielding the predictable result of allowing the outflow of the powder in the capsule to be mixed in the vortex and flow out the conduit to reach the lung of the user (Esteve: page 11, lines 6-25).
Allowable Subject Matter
Claim 12 is 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 a statement of reasons for the indication of allowable subject matter:
Regarding claim 12, the closest prior art record is O’Flaherty (US 20220305222) in view of Di Castri (US 20240042147) and further in view of Esteve (WO 2013016787).
In particular O’Flaherty discloses,
the spin chamber (O'Flaherty: spin chamber (device 1000); Di Castri: shape/position of channels and vortex chamber) of claim 9,
The modified device of O’Flaherty does not disclose wherein a first curved inlet channel of the two curved inlet channels has a greater depth along the longitudinal axis in its tangential section than in its funnel section, and wherein a second curved inlet channel of the two curved inlet channels has a greater depth in its funnel section than in its tangential section.
Esteve discloses an analogous inhaler using a capsule and a chamber with a vortex
wherein a second curved inlet channel of the two curved inlet channels has a greater depth in its funnel section than in its tangential section (see figs. 26-29; intake points 28 runs downwards from the top of the edge of the capsule receptacle 2 (creating a varied depth in the intake point/inlet channel); page 9, lines 4-26 such that the downstream/funnel section is a greater depth than its upstream/funnel section).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wall of the body and chamber channels of O’Flaherty with the modified construction of the air intake points and rounded wall as disclosed in Esteve to produce a desired restrictive effect that enhances the air flow control and consequently comprises a fine-tuned adjustment to the inhalatory resistance and ensuring a more stable air flow during inhalation, and the means for achieving specific pulmonary deposition profiles (Esteve: page 9, lines 4-26).
However, Esteve discloses both the intake points 28 running downwards from the top of the edge (page 9, lines 4-26) rather than having “a first curved inlet channel of the two curved inlet channels has a greater depth along the longitudinal axis in its tangential section than in its funnel section, and wherein a second curved inlet channel of the two curved inlet channels has a greater depth in its funnel section than in its tangential section”.
Therefore, O’Flaherty, Di Castri, and Esteve fail to teach, disclose or render obvious
“wherein a first curved inlet channel of the two curved inlet channels has a greater depth along the longitudinal axis in its tangential section than in its funnel section” in addition to other limitations.
Regarding claim 12, the closest prior art record is O’Flaherty (US 20220305222) in view of Di Castri (US 20240042147) and further in view of Hilliard (US 20210077756).
In particular O’Flaherty discloses,
the spin chamber (O'Flaherty: spin chamber (device 1000); Di Castri: shape/position of channels and vortex chamber) of claim 9,
The modified device of O’Flaherty does not disclose wherein a first curved inlet channel of the two curved inlet channels has a greater depth along the longitudinal axis in its tangential section than in its funnel section, and wherein a second curved inlet channel of the two curved inlet channels has a greater depth in its funnel section than in its tangential section.
Hilliard discloses a portable halotherapy device with a chamber that spins the particulates
wherein a first curved inlet channel of the two curved inlet channels has a greater depth along the longitudinal axis in its tangential section than in its funnel section (see figs. 10 and 11; curved/spiral arm air ducts 72 draw in air into the top of the grinding chamber 26 such that the height of each duct narrows slightly as it nears the center of the device/chamber, this is accomplished by ramping the floors of the ducts 72 slightly upward; [0055] and [0058]; therefore having a greater depth along the tangential section than in its funnel section).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wall of the body and chamber channels of O’Flaherty with the narrows air ducts disclosed in Hilliard to spiral inward and narrow as they near the center to accelerate the air more quickly in the direction of rotation; therefore, helping create a desired air pattern into the chamber (Hilliard: [0055]).
However, Hilliard discloses the height of each duct narrowing [0055] rather than having “a first curved inlet channel of the two curved inlet channels has a greater depth along the longitudinal axis in its tangential section than in its funnel section, and wherein a second curved inlet channel of the two curved inlet channels has a greater depth in its funnel section than in its tangential section”.
Therefore, O’Flaherty, Di Castri, and Esteve fail to teach, disclose or render obvious
“wherein a second curved inlet channel of the two curved inlet channels has a greater depth in its funnel section than in its tangential section” in addition to other limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Py (US 6302101) – a system and method for applying medicament into the nasal passage; where the nozzle mechanism has converging channel portions 3104b that converge into a swirling chamber 3103, figs. 11 and 14b; where fig. 28 shows the swirling chamber comprising a ramp to reduce head loss from the converging channel portions. While the converging channel portions appear to have a greater funnel/end section depth and the ramp appears to have a smaller end section depth, the ramp is not a converging channel portion/curved inlet channel, but rather part of the swirling chamber itself. Therefore, it does not disclose the first curved inlet channel and second curved inlet channel being two different depths as described in claim 12.
Kakade (US 20160067429) – discloses an analogous inhaler apparatus with a vortex chamber and a plurality of vortexing air inlets; however, it does not disclose the subject matter of claim 12
Trout (US 20230364362) – discloses an analogous inhaler apparatus with a vortex chamber, composition receptacle for a capsule, and opposing gas inlets with flow inlet paths that lead int the vortex chamber; the opposing gas inlets further comprise at least two different sections where the end portion of the flow inlet path has a greater depth than the gas inlet portion, see figs. 4a-4e and [0075]-[0076]; however, it does not disclose the first curved inlet channel and second curved inlet channel being two different depths as described in claim 12.
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/S.R.R./Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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