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 .
Response to Amendment
This office action is in response to the amendment filed 07/27/23. Claim(s) 1-16 have been amended, new claims 17-20 have been added, and no claims have been cancelled. Thus, claims 1-20 are presently pending in this application.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because line 1 contains implied language "is disclosed". A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 13 and 16 are objected to because of the following informalities:
In claim 13, line 5 "at least outlet" should be changed to --at least one outlet-- to correct a typographical error.
In claim 13, line 5 “the at least one medicament cavity” should be changed to –the at least one of the plurality of medicament cavities” for consistency.
In claim 16, line 3 “the at least one medicament cavity” should be changed to –the at least one of the plurality of medicament cavities” for consistency.
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 10, 14, and 18-19 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.
In claim 10, line 3 the limitation “a respective medicament cavity” is unclear if referring to the plurality of medicament cavities or a new medicament cavity.
In claim 14, lines 2 and 4 (two instances) the limitation “two medicament cavities” is unclear if referring to the plurality of medicament cavities or two new medicament cavities.
All remaining claims are rejected based on their dependency of a rejected base claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6, 8-9, 12-13, 15-17, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hickey (2005/0103337).
With respect to claim 1, Hickey discloses a dry powder inhaler (10, fig 3A) comprising at least one inlet (52p, fig 3E); at least one outlet (60p, fig 3E); and a dosage mechanism (15 and 50 in fig 3B) between the at least one inlet and the at least one outlet (see location in fig 3B) for arranging a dose of a dry powder medicament (see [0063]) such that the dose may be delivered upon inhalation at the at least one outlet (see [0075]), wherein the dosage mechanism comprises a dose wheel (15, fig 3E) structured and arranged to retain a plurality of medicament cavities (15b, fig 3E and 4B) for housing the dry powder medicament; and a dosing element (50, fig 3B) movable (retractable/extendable) between an inactive position (fig 7D) and a dose-administering position (fig 7G), the dosing element structured and arranged to enable fluid communication between at least one of the plurality of medicament cavities and the at least one outlet when in the dose-administering position (see [0094]).
With respect to claim 2, Hickey discloses the dose wheel is structured and arranged to rotate relative (see [0077]) to the dosing element between a plurality of dose delivery positions (see [0077], dispensing position for each of the plurality of medicament cavities).
With respect to claim 3, Hickey discloses each dose delivery position corresponds to an alignment between one or more of the plurality of medicament cavities and the dosing element (see [0077] where the medicament cavities align with the dosing element in the dispensing position).
With respect to claim 4, Hickey discloses each dose delivery position corresponds to an alignment between two of the plurality of medicament cavities and the dosing element (see [0077] where the medicament cavities align with the dosing element in the dispensing position one cavity with me dispensed while the adjacent cavities will be in a location relative to the dosing element).
With respect to claim 5, Hickey discloses a gear system (25,30,75; fig 3D) configured to rotate the dose wheel relative to the dosing element (see [0077]).
With respect to claim 6, Hickey discloses in the inactive position, the dosing element is arranged within the dose wheel (see fig 3B where the element 50 is within the wheel before slicing cavity 15b in the active position).
With respect to claim 8, Hickey discloses the dosing element comprises a manifold (51 and 52, fig 7C) arranged to provide fluid communication between the at least one inlet and at least one of the plurality of medicament cavities (through aperture 50a as seen in fig 7E) and between the at least one of the plurality of medicament cavities and the at least one outlet when in the dose- administering position (see [0080 and 85]).
With respect to claim 9, Hickey discloses the manifold comprises at least one first conduit (aperture 50a, fig 7E) and at least one second conduit (52ch, fig 7A), wherein, when in the dose- administering position the at least one first conduit is arranged to provide fluid communication between at least one medicament cavity and the at least one second conduit (see [0080] and fig 7A); and the at least one second conduit is arranged to provide fluid communication between the at least one first conduit and the at least one outlet (see [0085]).
With respect to claim 12, Hickey discloses the manifold further comprises at least one third conduit (see conduit formed between inlet 52p and channel 52ch in fig 7D) arranged to provide fluid communication between the at least one inlet and the at least one second conduit when in the dose-administering position (see fig 7D and [0101]).
With respect to claim 13, Hickey discloses each medicament cavity is sealed by a sealing element (15c, fig 6c), and wherein the dosing element is configured to at least partially remove the sealing element (see figs 7A-7B) from at least one of the plurality of medicament cavities when moving from the inactive position to the dose-administering position to enable fluid communication between the at least one medicament cavity and the at least outlet when in the dose-administering position (see [0094 and 103]).
With respect to claim 15, Hickey discloses the sealing element is foil (see [0108]).
With respect to claim 16, Hickey discloses the dosing element is configured to at least partially remove the sealing element by peeling (separating) the sealing element from the at least one medicament cavity when moving from the inactive position to the dose-administering position (see [0103]).
With respect to claim 17, Hickey discloses the sealing element is foil (see [0108]).
With respect to claim 20, Hickey discloses in the inactive position, the dosing element is arranged within the dose wheel (see fig 3B where the element 50 is within the wheel before slicing cavity 15b in the active position).
Claim(s) 1, 5, and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lewis (2011/0186047).
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Annotated fig 7A of Lewis.
With respect to claim 1, Lewis discloses a dry powder inhaler (10, fig 1B) comprising at least one inlet (see annotated fig 7A of Lewis and direction of flow arrow in fig 7C); at least one outlet (see annotated fig 7A of Lewis and direction of flow arrow in fig 7C); and a dosage mechanism (dose container assembly 20, fig 2A) between the at least one inlet and the at least one outlet (see the dose assembly between the inlet and outlet in fig 7A so the air can go into the does assembly and move the medicament back out to the user) for arranging a dose of a dry powder medicament (see [0105]) such that the dose may be delivered upon inhalation at the at least one outlet (see fig 7A and [0133]), wherein the dosage mechanism comprises a dose wheel (30, fig 2E) structured and arranged to retain a plurality of medicament cavities (30c, fig 2E) for housing the dry powder medicament (see [0107]); and a dosing element (220, fig 7A) movable between an inactive position (see position of 220 in fig 7A) and a dose-administering position (see position of 220, fig 7B), the dosing element structured and arranged to enable fluid communication between at least one of the plurality of medicament cavities and the at least one outlet when in the dose-administering position (see [0125-126]).
With respect to claim 5, Lewis discloses a gear system (240 fig 11 / 210 fig 12A) configured to rotate the dose wheel relative to the dosing element (see [0147]).
With respect to claim 7, Lewis discloses the gear system (240 fig 11 / 210 fig 12A) comprising a first gear mechanism (240, fig 11) and a second gear mechanism (210, fig 12A); the first gear mechanism is configured to rotate a dose wheel (20, fig 2E) (see [0147]); the second gear mechanism is configured to actuate a dosing element (220, fig 11)(see [0147]); and the first gear mechanism and the second gear mechanism are configured to interact such that the rotation of the dose wheel and the actuation the dosing element are provided in the same action (see [0147-148]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 10-11 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hickey in view of JP (JP3530004).
With respect to claim 10, Hickey shows all the elements as claimed above but lacks the first conduit includes two first conduits, each arranged to provide fluid communication between a respective medicament cavity and the at least one second conduit when in the dose-administering position.
However, JP teaches a dry powder inhaler (1, fig 3) comprising a conduit system (12A, 12B; fig 3) a first conduit includes two first conduits (see multiple instances of 12A in fig 2 of JP), each arranged to provide fluid communication between a medicament cavity (K, fig 3 of JP) and at least one second conduit when in the dose-administering position (see location of the two first conduits between K and second conduits 12B in figs 2-3 of JP).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first and second conduits of Hickey to include multiple first and second conduits as taught by JP so as to provide axial passages for dispensing the medicament radially.
With respect to claim 11, Hickey discloses all the elements as claimed above but lacks one second conduit includes two second conduits, each arranged to provide fluid communication between the at least one first conduit and the at least one outlet when in the dose-administering position.
However, JP teaches a dry powder inhaler (1, fig 3) comprising a conduit system (12A, 12B; fig 3) of at least one first conduit (see multiple instances of 12A in fig 2 of JP), and at least one second conduit includes two second conduits (see multiple instances of 12A in fig 2 of JP) each arranged to provide fluid communication between the at least one first conduit and the at least one outlet when in the dose-administering position (see location of the two second conduits between first conduits (12A) and outlet 13B in figs 2-3 of JP).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first and second conduits of Hickey to include the multiple first and second conduits as taught by JP so as to provide axial passages for dispensing the medicament radially.
With respect to claim 18, the modified Hickey shows the at least one second conduit includes two second conduits (multiple instances of 12B in figs 2-3 of JP), each arranged to provide fluid communication between the at least one first conduit and the at least one outlet when in the dose-administering position (see location of the two second conduits between first conduits (12A) and outlet 13B in figs 2-3 of JP).
With respect to claim 19, the modified Hickey shows the manifold further comprises at least one third conduit (7B, fig 3 of JP) to provide fluid communication between the at least one inlet and the at least one first conduit (see modification by JP where the conduits include conduit 7B between inlet H and first conduit 12A in fig 3 of JP).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hickey in view of Warden (2007/0221218).
With respect to claim 14, Hickey discloses the dosing element is configured to at least partially remove (separate) the sealing element from the medicament cavity when moving from the inactive position to the dose-administering position to enable fluid communication between the medicament cavity and the at least one outlet when in the dose-administering position (see [0103] of Hickey) but lacks the medicament cavity being two medicament cavities removing the sealing element simultaneously.
However, Warden teaches a dry powder inhaler (10, fig 2A) with a dosing wheel (27, fig 4A) comprising a plurality of medicament cavities (27w, fig 4A and embodiment of fig 4E) wherein a dosing element (40, fig 4A) is configured to at least partially remove a sealing element (29, fig 6B) from two medicament cavities (27a1 and 27a2, fig 4E; see fig 6B removing 29 from cavities A and B) simultaneously (see [0071]) when moving from the inactive position to the dose-administering position to enable fluid communication between the two medicament cavities and at least one outlet when in the dose-administering position (see [0074-75 and 85-87]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the medicament cavities (15b, fig 3B of Hickey) in Hickey to be two aligned cavities (27a1 and 27a2, fig 4E of Warden) as taught by Warden so as to provide different medicaments and/or dry powders for concurrent dispensing of in neighboring blisters for combination therapeutic treatments (see [0071] of Warden).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ganem (2007/0221216), Houzego (2010/0300442), Lastow (2010/0326440), and Giraud (2020/0139059) are cited to show additional dry powder inhalers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY E BALLER whose telephone number is (571)272-8153. The examiner can normally be reached Monday - Friday 8 AM - 4 PM.
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/KELSEY E BALLER/ Examiner, Art Unit 3785
/TU A VO/ Primary Examiner, Art Unit 3785