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 .
Priority
Acknowledgment is made of applicant's claim to priority to U.S. Non-Provisional App. No. 17/873,622 filed July 26, 2022; to PCT EP2022/067066 filed June 22, 2022; and to Foreign App. No. GB2111658.7 filed August 13, 2021.
Application Data Sheet filed October 25, 2024 perfected Applicant’s claim to priority to Foreign App. No. GB2111658.7 filed August 13, 2021, which is the effective filing date.
Status of Claims
This Office Action is responsive to the amendment filed on May 23, 2025. As directed by the amendment: claims 1 and 33 have been amended; and claims 31-32, 35, and 64 have been cancelled. Thus, claims 1-3, 6, 8, 29, 33, 37, 39-41, 49-63, and 65-78 are presently pending in this application.
Claim 1 was provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 9 of co-pending Application No. 17/873,662. The abandonment of co-pending Application No. 17/873,662 obviates the provisionally rejection under 35 U.S.C. 101. Applicant’s amendments obviate the previous drawing objections. Applicant’s amendments to claim 48 obviates the previous objection made thereto.
Claims 1-3, 6, 8, 29, 31-33, 35, 37, 39-41, 46-48, and 63-78 were previously rejected under 35 U.S.C. 103 as being unpatentable over Shaikh et al. (WO 2021/195353 A1) in view of Anderson et al. (U.S. Pub. No. 2009/0314291). Claims 49-62 were previously rejected under 35 U.S.C. 103 as being unpatentable further in view of Huang et al. (U.S. Pub. No. 2020/0324064).
Applicant's amendments necessitated the application of new grounds of rejection in light of prior art, shown below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: dispensing mechanism; indexing mechanism; and peeling mechanism in all pending claims.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 37 and 49-62 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.
Claims 37 and 49-62 recites the limitation "wherein the different medicaments for simultaneous inhalation". There is insufficient antecedent basis for the “different medicaments” limitation in the claim. Claim 1, to which claims 37 and 49-62 depend, recites “such that the dry powder inhaler can be used for simultaneous inhalation of medicaments from different blisters.”, however this indicates that the different blisters comprise medicament but does not recite that the medicaments are different. For the purpose of this Office Action --wherein the medicament carriers comprise respective different medicament for simultaneous inhalation which--.
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 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 1-3, 6, 8, 29, 33, 37, 39-41, 46-48, and 63-78 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (U.S. Pub. No. 2009/0314291; hereinafter: “Anderson”) in view of Shaikh et al. (WO 2021/195353 A1; hereinafter: “Shaikh”).
Regarding Claim 1, Anderson discloses a dry powder inhaler for delivering medicament having regions for accommodating unused and used portions of the medicament carrier (Fig. 3a, 3b; ¶¶ 0193-0196); a plurality of medicament carriers (100, 300A, 300B, 400A, 400B; Fig. 1, 3a, 3b, 9) each having a plurality of spaced-apart medicament doses (104, 304a, 304b; Fig. 3a, 3b; ¶¶ 0182-0188, 0191, 0192, 0194, 0196), a mouthpiece (426; Fig. 4b, 4c, 5b, 5c, 6, 12, 13) component joined to the housing Fig. 4b, 4c, 5b, 5c, 6, 12, 13; ¶¶ 0199-0200) and through which a user is able to inhale (¶¶ 0199-0200), the mouthpiece component including surfaces (A, Fig. A annotated below) for contacting lips of the user; a dispensing mechanism (440, 448a, 448b; Fig. 6-9) arranged in the housing for moving a next medicament dose of the medicament carriers carriers carriers wherein the movement of the mouthpiece cover causes movement of at least one resilient drive pawl (446b; Fig. 6-8; ¶¶ 0201, 0214), and wherein the at least one resilient drive pawl selectively engages a toothed drive gear (444b; Fig. 6-8) of the dispensing mechanism for driving the dispensing mechanism to move the next medicament dose of the medicament carrier to the dispensing position (Fig. 6-8; ¶¶ 0210-0212, 0214-0219), the at least one resilient drive pawl being provided about a first gear wheel (446; Fig. 6-8) which is rotatably driven by the mouthpiece cover (Fig. 6-8; ¶¶ 0201-0221), and the drive gear is provided as ratchet teeth about a second gear wheel (442; Fig. 6-8) arranged to rotate coaxially with the first gear wheel (Fig. 6-8; ¶¶ 0201-0221), wherein the first gear wheel is provided with five resilient pawls at 72 degree intervals (Fig. 6-8) and the second gear wheel is provided with five teeth at 72 degree intervals, and movement of the mouthpiece cover from the second position to the third position encloses an angle about the rotation axis of 72 degrees [Fig. 6-8; ¶¶ 0201-0221; Examiner notes: Anderson depicts and discloses the first gear wheel as having five equi-angularly spaced-apart resilient pawls (Fig. 7b; ¶ 0214) that match the five equi-angularly spaced-apart teeth of the second gear. As such, to be equi-angularly spaced-apart, the five resilient pawls and teeth must be at 72 degree intervals], wherein each of the medicament carriers carrier comprises an elongate blister strip (102, 302a, 302b, 402a, 402b; Fig. 1, 3a, 3b, 9) having a base layer (410a, 410b; Fig. 9) defining spaced-apart blister openings containing medicament doses (Fig. 9; ¶¶ 0207, 0212), and a cover layer (412a, 412b; Fig. 9) adhesively bonded to the base layer to close the blisters (Fig. 1; ¶¶ 0182-0188, 0207, 0212), and wherein the cover layer is arranged to be peeled from the base layer (Fig. 1, 3a, 3b; ¶¶ 0182-0188, 0191-0209), wherein the dispensing mechanism comprises: an indexing mechanism (440, 430a, 430b; Fig. 6-8) for moving a blister of each of the elongate blister strips containing the next medicament dose to the dispensing position (¶¶ 0126-0131, 0139-0144, 0208-0209, 0212, 0216, 0220-0221); and a peeling mechanism (448a, 448b; Fig. 6, 9) for peeling the cover layer from each of the blister strips for placing the medicament doses in fluid communication with an air flow path (483; Fig. 12, 13; ¶ 0225, 0231-0233) ready for inhalation by the user (¶¶ 0133, 0139-0144, 0207, 0209, 0229), and wherein the indexing mechanism is arranged to move at least two blisters of the elongate blister strips containing the next medicament doses to the dispensing position (¶¶ 0126-0131, 0139-0144, 0190-0209, 0212, 0216, 0220-0221), and the peeling mechanism is arranged to simultaneously begin to peel the cover layer from the at least two blisters for placing at least two medicament doses in fluid communication with the air flow path ready for inhalation by the user, such that the dry powder inhaler can be used for simultaneous inhalation of medicaments from different blisters (¶¶ 0133, 0139-0144, 0190-0209, 0212, 0216, 0220-0221, 0229).
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Figure A, Adapted from Figure 13 of Anderson.
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Figure B, Adapted from Figure 5b of Anderson.
Anderson does not specifically disclose the dry powder inhaler wherein the mouthpiece component is completely covered and the mouthpiece cover has moved about the rotation axis, from the first position, through an angle of at least 5 degrees, and from the second position to a third position in which the mouthpiece component is completely uncovered, and wherein, the first gear wheel is provided with four resilient pawls at 90 degree intervals and the second gear wheel is provided with four teeth at 90 degree intervals, and movement of the mouthpiece cover from the second position to the third position encloses an angle about the rotation axis of 90 degrees.
Shaikh discloses a dry powder inhaler for delivering medicament from at least one medicament carrier (5, 5a, 5b, 41a, 41b; Fig. 4, 5, 9, 13, 19, 20, 100A, 100B, 101) having a plurality of spaced-apart medicament doses (5, 5a, 5b; Fig. 4, 5, 9, 13, 19, 20, 100A, 100B, 101; ¶¶ 0073, 00408, 00409, 00413-00425), the dry powder inhaler comprising: a housing (4, 13, 14; Fig. 3, 4, 24-30) having regions for accommodating unused (A and B; Fig. C annotated below) and used (C and D; Fig. C annotated below) portions of the medicament carrier (¶¶ 00167, ¶¶ 00408-00410); a mouthpiece component (29; Fig. 2C, 4-6, 8D, 8E, 9, 10A) joined to the housing (Fig. 2C, 4-6, 8D, 8E, 9, 10A) and through which a user is able to inhale (¶¶ 00406, 00408, 00411, 00413-00420, 00455, 00459), the mouthpiece component including surfaces (E and F; Fig. C annotated below) for contacting lips of the user; a dispensing mechanism (Fig. 4-8E; ¶¶ 00408-00428) arranged in the housing for moving a next medicament dose of the medicament carrier to a dispensing position (¶¶ 00127, 00408-00428); and a mouthpiece cover (3; Fig. 1A, 1B, 3-7A, 8A, 8C-10A, 23) rotatably connected to the housing for sequential movement about a rotation axis (Axis of drive gear 2; Fig. 8A, 8C-8E ) from a first position (Fig. 2A, 5-7A, 8A) in which the mouthpiece component is completely covered to a second position (Fig. 2B, 8C; ¶¶ 00244, 00406, 00450, 00461), wherein the mouthpiece component is completely covered (Fig. 2B, 8C; ¶¶ 00244, 00406, 00450, 00461) and the mouthpiece cover has moved about the rotation axis, from the first position, through an angle of at least 5 degrees (¶¶ 00117, 00119, 00158, 00159, 00246, 00259, 00413, 00414), and from the second position to a third position (Fig. 2C, 8E; ¶¶ 00246, 00406, 00450) in which the mouthpiece component is completely uncovered (Fig. 2C, 8E; ¶¶ 00246, 00406, 00450), the second position being between the first and third positions (Fig. 2A-2C, 8A-8E; ¶¶ 00117, 00119, 00158, 00159, 00244, 00246, 00406, 00450, 00461), wherein the mouthpiece cover is coupled to the dispensing mechanism such that movement of the mouthpiece cover drives the dispensing mechanism (Fig. 4-8E; ¶¶ 00406, 00408-00428, 00450, 00461), and movement of the mouthpiece cover from the first position to the second position does not cause the next medicament dose of the medicament carrier to move (“idle motion”; ¶¶ 00114, 00118, 00119, 00158, 00159, 00246, 0259, 00413, 00416-00420), and movement of the mouthpiece cover from the second position to the third position does cause the next medicament dose of the medicament carrier to be moved to the dispensing position (¶¶ 00406-00428; Fig. 2A-2C, 8A-8E), with the next medicament dose starting to move to the dispensing position at a point where the mouthpiece cover moves through the second position the movement of the mouthpiece cover causes movement of at least one resilient drive pawl (40a, 40b; Fig. 8B, 16, 17; ¶¶ 00413-00431), and the at least one resilient drive pawl selectively engages a toothed drive gear (45a, 45b; Fig. 8B, 11, 12, 16, 17) of the dispensing mechanism for driving the dispensing mechanism to move the next medicament dose of the medicament carrier to the dispensing position (¶¶ 00413-00431) for the purpose of allowing for idle movement that decreases the likelihood of the medicament dispenser being actuated by accident, such as by inadvertently being partially opened in the pocket or personal item such as a purse or backpack of a user (¶ 0119).
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Figure C, Adapted from Figure 5 of Shaikh.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify dry powder inhaler of Anderson to include the wherein the mouthpiece component is completely covered and the mouthpiece cover has moved about the rotation axis, from the first position, through an angle of at least 5 degrees, and from the second position to a third position in which the mouthpiece component is completely uncovered, as taught by Shaikh for the purpose of allowing for idle movement that decreases the likelihood of the medicament dispenser being actuated by accident, such as by inadvertently being partially opened in the pocket or personal item such as a purse or backpack of a user (See Shaikh: ¶ 0119).
The modified device of Anderson does not specifically disclose the dry powder inhaler wherein, the first gear wheel is provided with four resilient pawls at 90 degree intervals and the second gear wheel is provided with four teeth at 90 degree intervals, and movement of the mouthpiece cover from the second position to the third position encloses an angle about the rotation axis of 90 degrees.
The modified device of Anderson discloses the dry powder inhaler wherein the first gear wheel is provided with five resilient pawls at 72 degree intervals (See Anderson: Fig. 6-8) and the second gear wheel is provided with five teeth at 72 degree intervals, and movement of the mouthpiece cover from the second position to the third position encloses an angle about the rotation axis of 72 degrees [See Anderson: Fig. 6-8; ¶¶ 0201-0221; Examiner notes: The modified device of Shaikh depicts and discloses the first gear wheel as having five equi-angularly spaced-apart resilient pawls (See Anderson: Fig. 7b; ¶ 0214) that match the five equi-angularly spaced-apart teeth of the second gear. As such, to be equi-angularly spaced-apart, the five resilient pawls and teeth must be at 72 degree intervals]. As such, the number of equi-angularly spaced-apart resilient pawls renders the degree intervals a result effective variable in that changing the number of equi-angularly spaced-apart resilient pawls directly changes the degree interval which changes the enclosed the angle being about the rotation axis from the movement from second position to the third position. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the modified device of Anderson to have the number of equi-angularly spaced-apart resilient pawls as claimed, as it involves only adjusting the number of a component (See MPEP 2144.04).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device of Anderson by providing the first gear wheel with four resilient pawls at 90 degree intervals and providing the second gear wheel with four teeth at 90 degree intervals, such that movement of the mouthpiece cover from the second position to the third position encloses an angle about the rotation axis of 90 degrees, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (See MPEP: 2144.05(II).
Regarding Claim 2, the modified device of Anderson discloses the dry powder inhaler wherein movement of the mouthpiece cover from the first position to the second position encloses an angle about the rotation axis of from 5 to 30 degrees (See Shaikh: ¶¶ 00117, 00158, 00159, 00246, 00259, 00413, 00414).
Regarding Claim 3, the modified device of Anderson discloses the dry powder inhaler, shown above.
The modified device of Anderson does not explicitly disclose the dry powder inhaler wherein movement of the mouthpiece cover from the second position to a position at which the mouthpiece component starts to be exposed encloses an angle of at least 5 degrees.
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 the modified device of Anderson to have the movement of the mouthpiece cover from the second position to a position at which the mouthpiece component starts to be exposed to encloses an angle of at least 5 degrees 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) (See MPEP: 2144.04 (IV)(A)). In the instant case, the modified device of Shaikh would not operate differently with the claimed angle of rotation range and since the mouthpiece cover is intended to from the second position to a position at which the mouthpiece component starts to be exposed the device would function appropriately having the claimed angle of rotation range. Further, applicant places no criticality on the range claimed, indicating simply that the angle of rotation “may” be within the claimed ranges (Instant Specification: Pg. 4, ln 24-27).
Regarding Claim 6, the modified device of Anderson discloses the dry powder inhaler wherein, on movement of the mouthpiece cover from the first position to the second position, the at least one resilient drive pawl is not engaged with any teeth of the drive gear (See Shaikh: ¶¶ 00127, 00408-00428, See Anderson: Fig. 7A; ¶¶ 0214-0221), and, on movement of the mouthpiece cover from the second position to the third position, the at least one resilient drive pawl is engaged with at least one tooth of the drive gear (See Shaikh: ¶¶ 00127, 00408-00428, See Anderson: Fig. 7b; ¶¶ 0214-0221).
Regarding Claim 8, the modified device of Anderson discloses the dry powder inhaler wherein the first gear wheel is arranged to rotate forwards and backwards when the mouthpiece cover is opened and closed, respectively (See Anderson: Fig. 6-8; ¶¶ 0201-0221), and wherein the second gear wheel is arranged to rotate forwards when driven forwards by the first gear wheel and not to rotate backwards (See Anderson: Fig. 6-8; ¶¶ 0201-0221).
Regarding Claim 29, the modified device of Anderson discloses the dry powder inhaler further comprising a manifold (See Shaikh: 12; Fig. 4, 5, 9, 13, 14, 97, See Anderson: 450; Fig. 6, 10, 12-15c) arranged in the housing, the manifold defining at least part of an air flow path (See Shaikh: 22, 24a, 24b; ¶¶ 00413-00418, 00420, 00421, 00451-00459; Fig. 96-99, See Anderson: 483; Fig. 12, 13; ¶ 0225, 0231-0233) extending from an air inlet (See Shaikh: 62a, 62b; Fig. 97, 98A, 99, See Anderson: 470; Fig. 4b, 4c, 10, 12) to the mouthpiece component, the manifold also defining the dispensing position for the next medicament dose of the medicament carrier (See Shaikh: ¶¶ 00413-00418, 00420, 00421, 00451-00459, See Anderson: ¶¶ 0216, 0221-03235, 0243-0246), wherein the dispensing mechanism is also arranged for placing the next medicament dose at the dispensing position in fluid communication with the air flow path, ready for inhalation by the user (See Shaikh: ¶¶ 00413-00418, 00420, 00421, 00451-00459, See Anderson: ¶¶ 0203-0206, 0216, 0221).
Regarding Claim 33, the modified device of Anderson discloses the dry powder inhaler wherein
Regarding Claim 37, the modified device of Anderson discloses the dry powder inhaler wherein the different medicaments for simultaneous inhalation comprise budesonide in a first blister and formoterol in a second blister; or beclomethasone in a first blister and formoterol in a second blister; or fluticasone in a first blister and salmeterol in a second blister, or fluticasone in a first blister and albuterol in a second blister, or fluticasone in a first blister and vilanterol in a second blister, or umeclidinium in a first blister and vilanterol in a second blister, or two selected from umeclidinium, fluticasone and vilanterol in a first blister, the remaining medicament from umeclidinium, fluticasone and vilanterol in a second blister (See Shaikh: ¶¶ 0051-0054, 0062-0068).
Regarding Claim 39, the modified device of Anderson discloses the dry powder inhaler wherein for delivering medicament from a plurality of medicament carriers (See Anderson: 402a, 402b; Fig. 9; ¶¶ 0198, 0199) each having a plurality of spaced-apart medicament doses (See Anderson: “pockets”, 404a, 404b; Fig. 4a-5c, 9; ¶¶ 0198-0200, 0207-0209, 0212, 0216, 0229, 0231, 0244). wherein the dry powder inhaler comprises exactly two medicament carriers (See Anderson: 402a, 402b; Fig. 9; ¶¶ 0198, 0199)
Regarding Claim 40, the modified device of Anderson discloses the dry powder inhaler wherein each of the medicament carriers comprises an elongate blister strip having a base layer (See Anderson: 410a, 410b; Fig. 9) defining spaced-apart blister openings containing medicament doses (See Anderson: Fig. 9; ¶¶ 0207, 0212), and a cover layer (See Anderson: 412a, 412b; Fig. 9) adhesively bonded to the base layer to close the blisters (See Anderson: ¶¶ 0182-0185, 0207, 0212), and wherein the cover layer is arranged to be peeled from the base layer (See Anderson: ¶¶ 0182-0185, 0207, 0212).
Regarding Claim 41, the modified device of Anderson discloses the dry powder inhaler wherein the dispensing mechanism comprises: an indexing mechanism (See Anderson: 440, 430a, 430b; Fig. 6-8) for moving a blister of each of the elongate blister strips containing the next medicament to the dispensing position (See Anderson: ¶¶ 0126-0131, 0139-0144, 0208-0209, 0212, 0216, 0220-0221); and a peeling mechanism (See Anderson: 448a, 448b; Fig. 6, 9) for peeling the cover layer from each of the blister strips for placing the medicament doses in fluid communication with an air flow path (See Anderson: 483; Fig. 12, 13; ¶ 0225, 0231-0233) ready for simultaneous inhalation by the user(See Anderson: ¶¶ 0133, 0139-0144, 0207, 0209, 0212, 0229).
Regarding Claim 46, the modified device of Anderson discloses the dry powder inhaler wherein the at least one resilient drive pawl is provided about an outside of the first gear wheel (See Anderson: Fig. 6-8; ¶¶ 0201-0221) and the drive gear is provided as an internal gear about the second gear wheel (See Anderson: Fig. 6-8; ¶¶ 0201-0221).
Regarding Claim 47, the modified device of Anderson discloses the dry powder inhaler, wherein the second gear wheel is provided with a ratchet (See Anderson: 444a; Fig. 8) and pawl (See Anderson: 487; Fig. 8) arrangement for preventing reverse rotation (See Anderson: ¶ 0218).
Regarding Claim 48, the modified device of Anderson discloses the dry powder inhaler wherein at the second position, the resilient drive pawl has just been brought into contact with the toothed drive gear (See Anderson: Fig. 7b; ¶¶ 0214-0216, 0218-0219).
Regarding Claim 63, Anderson discloses a dry powder inhaler for delivering medicament, the dry powder inhaler comprising: a housing (420; Fig. 4a-6,12, 13) having regions for accommodating unused and used portions of the medicament carrier (Fig. 3a, 3b; ¶¶ 0193-0196); a plurality of medicament carriers (100, 300A, 300B, 400A, 400B; Fig. 1, 3a, 3b, 9) each having a plurality of spaced-apart medicament doses (104, 304a, 304b; Fig. 3a, 3b; ¶¶ 0182-0188, 0191, 0192, 0194, 0196), a mouthpiece (426; Fig. 4b, 4c, 5b, 5c, 6, 12, 13) component joined to the housing Fig. 4b, 4c, 5b, 5c, 6, 12, 13; ¶¶ 0199-0200) and through which a user is able to inhale (¶¶ 0199-0200), the mouthpiece component including surfaces (A, Fig. A annotated above) for contacting lips of the user; a dispensing mechanism (440, 448a, 448b; Fig. 6-9) arranged in the housing for moving a next medicament dose of the medicament carriers position to the second position does not cause the next medicament dose of the medicament carriers equi-angularly spaced-apart resilient pawls (Fig. 7b; ¶ 0214) that match the five equi-angularly spaced-apart teeth of the second gear. As such, to be equi-angularly spaced-apart, the five resilient pawls and teeth must be at 72 degree intervals], wherein each of the medicament carriers carrier comprises an elongate blister strip (102, 302a, 302b, 402a, 402b; Fig. 1, 3a, 3b, 9) having a base layer (410a, 410b; Fig. 9) defining spaced-apart blister openings containing medicament doses (Fig. 9; ¶¶ 0207, 0212), and a cover layer (412a, 412b; Fig. 9) adhesively bonded to the base layer to close the blisters (Fig. 1; ¶¶ 0182-0188, 0207, 0212), and wherein the cover layer is arranged to be peeled from the base layer (Fig. 1, 3a, 3b; ¶¶ 0182-0188, 0191-0209), wherein the dispensing mechanism comprises: an indexing mechanism (440, 430a, 430b; Fig. 6-8) for moving a blister of each of the elongate blister strips containing the next medicament dose to the dispensing position (¶¶ 0126-0131, 0139-0144, 0208-0209, 0212, 0216, 0220-0221); and a peeling mechanism (448a, 448b; Fig. 6, 9) for peeling the cover layer from each of the blister strips for placing the medicament doses in fluid communication with an air flow path (483; Fig. 12, 13; ¶ 0225, 0231-0233) ready for inhalation by the user (¶¶ 0133, 0139-0144, 0207, 0209, 0229), and wherein the indexing mechanism is arranged to move at least two blisters of the elongate blister strips containing the next medicament doses to the dispensing position (¶¶ 0126-0131, 0139-0144, 0190-0209, 0212, 0216, 0220-0221), and the peeling mechanism is arranged to simultaneously begin to peel the cover layer from the at least two blisters for placing at least two medicament doses in fluid communication with the air flow path ready for inhalation by the user, such that the dry powder inhaler can be used for simultaneous inhalation of medicaments from different blisters (¶¶ 0133, 0139-0144, 0190-0209, 0212, 0216, 0220-0221, 0229).
Anderson does not specifically disclose the dry powder inhaler wherein the mouthpiece component is completely covered and the mouthpiece cover has moved about the rotation axis, from the first position, through an angle of at least 5 degrees, and from the second position to a third position in which the mouthpiece component is completely uncovered, and wherein, the first gear wheel is provided with four resilient pawls at 90 degree intervals and the second gear wheel is provided with four teeth at 90 degree intervals, and movement of the mouthpiece cover from the second position to the third position encloses an angle about the rotation axis of 90 degrees and wherein the medicament carriers comprise respective different medicament for simultaneous inhalation.
Shaikh discloses a dry powder inhaler for delivering medicament from at least one medicament carrier (5, 5a, 5b, 41a, 41b; Fig. 4, 5, 9, 13, 19, 20, 100A, 100B, 101) having a plurality of spaced-apart medicament doses (5, 5a, 5b; Fig. 4, 5, 9, 13, 19, 20, 100A, 100B, 101; ¶¶ 0073, 00408, 00409, 00413-00425), wherein the medicament carriers comprise respective different medicament for simultaneous inhalation (See Shaikh: ¶¶ 0045-0054, 0062-0068, 0073, 0079, 00408-00463), the dry powder inhaler comprising: a housing (4, 13, 14; Fig. 3, 4, 24-30) having regions for accommodating unused (A and B; Fig. C annotated above) and used (C and D; Fig. C annotated above) portions of the medicament carrier (¶¶ 00167, ¶¶ 00408-00410); a mouthpiece component (29; Fig. 2C, 4-6, 8D, 8E, 9, 10A) joined to the housing (Fig. 2C, 4-6, 8D, 8E, 9, 10A) and through which a user is able to inhale (¶¶ 00406, 00408, 00411, 00413-00420, 00455, 00459), the mouthpiece component including surfaces (E and F; Fig. C annotated above) for contacting lips of the user; a dispensing mechanism (Fig. 4-8E; ¶¶ 00408-00428) arranged in the housing for moving a next medicament dose of the medicament carrier to a dispensing position (¶¶ 00127, 00408-00428); and a mouthpiece cover (3; Fig. 1A, 1B, 3-7A, 8A, 8C-10A, 23) rotatably connected to the housing for sequential movement about a rotation axis (Axis of drive gear 2; Fig. 8A, 8C-8E ) from a first position (Fig. 2A, 5-7A, 8A) in which the mouthpiece component is completely covered to a second position (Fig. 2B, 8C; ¶¶ 00244, 00406, 00450, 00461), wherein the mouthpiece component is completely covered (Fig. 2B, 8C; ¶¶ 00244, 00406, 00450, 00461) and the mouthpiece cover has moved about the rotation axis, from the first position, through an angle of at least 5 degrees (¶¶ 00117, 00119, 00158, 00159, 00246, 00259, 00413, 00414), and from the second position to a third position (Fig. 2C, 8E; ¶¶ 00246, 00406, 00450) in which the mouthpiece component is completely uncovered (Fig. 2C, 8E; ¶¶ 00246, 00406, 00450), the second position being between the first and third positions (Fig. 2A-2C, 8A-8E; ¶¶ 00117, 00119, 00158, 00159, 00244, 00246, 00406, 00450, 00461), wherein the mouthpiece cover is coupled to the dispensing mechanism such that movement of the mouthpiece cover drives the dispensing mechanism (Fig. 4-8E; ¶¶ 00406, 00408-00428, 00450, 00461), and movement of the mouthpiece cover from the first position to the second position does not cause the next medicament dose of the medicament carrier to move (“idle motion”; ¶¶ 00114, 00118, 00119, 00158, 00159, 00246, 0259, 00413, 00416-00420), and movement of the mouthpiece cover from the second position to the third position does cause the next medicament dose of the medicament carrier to be moved to the dispensing position (¶¶ 00406-00428; Fig. 2A-2C, 8A-8E), with the next medicament dose starting to move to the dispensing position at a point where the mouthpiece cover moves through the second position the movement of the mouthpiece cover causes movement of at least one resilient drive pawl (40a, 40b; Fig. 8B, 16, 17; ¶¶ 00413-00431), and the at least one resilient drive pawl selectively engages a toothed drive gear (45a, 45b; Fig. 8B, 11, 12, 16, 17) of the dispensing mechanism for driving the dispensing mechanism to move the next medicament dose of the medicament carrier to the dispensing position (¶¶ 00413-00431), such that the dry powder inhaler can be used for simultaneous inhalation of different medicaments from different blisters (¶¶ 0045-0054, 0062-0068, 0073, 0079, 00408-00463) for the purpose of allowing for idle movement that decreases the likelihood of the medicament dispenser being actuated by accident, such as by inadvertently being partially opened in the pocket or personal item such as a purse or backpack of a user (¶ 0119).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify dry powder inhaler of Anderson to include the wherein the mouthpiece component is completely covered and the mouthpiece cover has moved about the rotation axis, from the first position, through an angle of at least 5 degrees, and from the second position to a third position in which the mouthpiece component is completely uncovered, wherein the medicament carriers comprise respective different medicament for simultaneous inhalation, as taught by Shaikh for the purpose of allowing for idle movement that decreases the likelihood of the medicament dispenser being actuated by accident, such as by inadvertently being partially opened in the pocket or personal item such as a purse or backpack of a user (See Shaikh: ¶ 0119).
The modified device of Anderson does not specifically disclose the dry powder inhaler wherein, the first gear wheel is provided with four resilient pawls at 90 degree intervals and the second gear wheel is provided with four teeth at 90 degree intervals, and movement of the mouthpiece cover from the second position to the third position encloses an angle about the rotation axis of 90 degrees.
The modified device of Anderson discloses the dry powder inhaler wherein the first gear wheel is provided with five resilient pawls at 72 degree intervals (See Anderson: Fig. 6-8) and the second gear wheel is provided with five teeth at 72 degree intervals, and movement of the mouthpiece cover from the second position to the third position encloses an angle about the rotation axis of 72 degrees [See Anderson: Fig. 6-8; ¶¶ 0201-0221; Examiner notes: The modified device of Shaikh depicts and discloses the first gear wheel as having five equi-angularly spaced-apart resilient pawls (See Anderson: Fig. 7b; ¶ 0214) that match the five equi-angularly spaced-apart teeth of the second gear. As such, to be equi-angularly spaced-apart, the five resilient pawls and teeth must be at 72 degree intervals]. As such, the number of equi-angularly spaced-apart resilient pawls renders the degree intervals a result effective variable in that changing the number of equi-angularly spaced-apart resilient pawls directly changes the degree interval which changes the enclosed the angle being about the rotation axis from the movement from second position to the third position. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the modified device of Anderson to have the number of equi-angularly spaced-apart resilient pawls as claimed, as it involves only adjusting the number of a component (See MPEP 2144.04).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device of Anderson by providing the first gear wheel with four resilient pawls at 90 degree intervals and providing the second gear wheel with four teeth at 90 degree intervals, such that movement of the mouthpiece cover from the second position to the third position encloses an angle about the rotation axis of 90 degrees, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (See MPEP: 2144.05(II).
Regarding Claim 65, the modified device of Anderson discloses the dry powder inhaler wherein the plurality of medicament carriers is
Regarding Claim 66, the modified device of Anderson discloses the dry powder inhaler wherein the plurality of medicament carriers is
Regarding Claim 67, the modified device of Anderson discloses the dry powder inhaler wherein the plurality of medicament carriers is 00408, 00409, 00413-00425, See Anderson: 104, 106, 108; Fig. 1; ¶ 0182), wherein the different medicaments for simultaneous inhalation are beclomethasone in a first medicament carrier and formoterol in a second medicament carrier (See Shaikh: ¶¶ 0045-0054, 0062-0068, 0073, 0079, 00408-00463; Examiner notes: Shaikh discloses the medicament carriers can contain different medicaments for simultaneous inhalation).
Regarding Claim 68, the modified device of Anderson discloses the dry powder inhaler wherein the plurality of medicament carriers is
Regarding Claim 69, the modified device of Anderson discloses the dry powder inhaler wherein the plurality of medicament carriers is
Regarding Claim 70, the modified device of Shaikh discloses the dry powder inhaler wherein the dry powder inhaler comprises exactly two medicament carriers (See Shaikh: 5a, 5b; Fig. 4, 5, 9, 13, 19, 20, 100A, 100B, 101; ¶¶ 0073, 00408, 00409, 00413-00425, See Anderson: 104, 106, 108; Fig. 1; ¶ 0182), wherein the different medicaments for simultaneous inhalation are fluticasone in a first medicament carrier and albuterol in a second medicament carrier (See Shaikh: ¶¶ 0045-0054, 0062-0068, 0073, 0079, 00408-00463; Examiner notes: Shaikh discloses the medicament carriers can contain different medicaments for simultaneous inhalation).
Regarding Claim 71, the modified device of Anderson discloses the dry powder inhaler wherein the plurality of medicament carriers is
Regarding Claim 72, the modified device of Anderson discloses the dry powder inhaler wherein the plurality of medicament carriers is
Regarding Claim 73, the modified device of Anderson discloses the dry powder inhaler wherein the plurality of medicament carriers is 0079, 00408-00463; Examiner notes: Shaikh discloses the medicament carriers can contain different medicaments for simultaneous inhalation).
Regarding Claim 74, the modified device of Anderson discloses the dry powder inhaler wherein the plurality of medicament carriers is
Regarding Claim 75, the modified device of Anderson discloses the dry powder inhaler wherein the plurality of medicament carriers is
Regarding Claim 76, the modified device of Anderson discloses the dry powder inhaler wherein the plurality of medicament carriers is formoterol and budesonide in a second medicament carrier (See Shaikh: ¶¶ 0045-0054, 0062-0068, 0073, 0079, 00408-00463; Examiner notes: Shaikh discloses the medicament carriers can contain different medicaments and co-formulation compatible components for simultaneous inhalation).
Regarding Claim 77, the modified device of Anderson discloses the dry powder inhaler wherein the plurality of medicament carriers is
Regarding Claim 78, the modified device of Anderson discloses the dry powder inhaler wherein the plurality of medicament carriers is .
Claims 49-62 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson in view of Shaikh as applied to claim 1 above, and further in view of Huang et al. (U.S. Pub. No. 2020/0324064; hereinafter: “Huang”).
Regarding Claim 49, the modified device of Anderson discloses the dry powder inhaler wherein the medicament carriers comprise respective different medicament for simultaneous inhalation, at least including: fluticasone, formoterol, indacaterol, vilanterol, salmeterol, albuterol, budesonide, beclomethasone, ipratropium, umeclidinium, and glycopyrronium (See Shaikh: ¶¶ 0045-0054, 0062-0068, 0073, 0079, 00408-00463).
The modified device of Anderson does not specifically disclose the dry powder inhaler
Huang teaches an inhalation device for administering powdered pharmaceutical composition comprising at least two blisters (402; Fig. 5c, 5d) of a elongate blister strip (401; Fig. 5a-5d) containing the next medicament doses to the dispensing position (¶¶ 0038-0041, 0045), and wherein the different medicaments for simultaneous inhalation are a first medicament in a first blister (402; Fig. 5c, 5d) and formoterol in a second blister (402; Fig. 5c, 5d) such that the dry powder inhaler can be used for simultaneous inhalation of different medicaments from different blisters (¶¶ 0006-0007, 0013-0025, 0058, 0059, 0061, 0062) for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (¶ 0059).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Anderson to include the different medicaments for simultaneous inhalation are budesonide in a first blister and formoterol in a second blister as taught by Huang for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (See Huang: ¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (See Huang: ¶ 0059).
Regarding Claim 50, the modified device of Anderson discloses the dry powder inhaler wherein the medicament carriers comprise respective different medicament for simultaneous inhalation, at least including: fluticasone, formoterol, indacaterol, vilanterol, salmeterol, albuterol, budesonide, beclomethasone, ipratropium, umeclidinium, and glycopyrronium (See Shaikh: ¶¶ 0045-0054, 0062-0068, 0073, 0079, 00408-00463).
The modified device of Anderson does not specifically disclose the dry powder inhaler
Huang teaches an inhalation device for administering powdered pharmaceutical composition an indexing mechanism (416, 422; Fig. 2-4a) at least two blisters (402; Fig. 5c, 5d) of a elongate blister strip (401; Fig. 5a-5d) containing the next medicament doses to the dispensing position (¶¶ 0038-0041, 0045), and wherein the different medicaments for simultaneous inhalation are a first medicament in a first blister (402; Fig. 5c, 5d) and albuterol in a second blister (402; Fig. 5c, 5d) such that the dry powder inhaler can be used for simultaneous inhalation of different medicaments from different blisters (¶¶ 0006-0007, 0013-0025, 0058, 0059, 0061, 0062) for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (¶ 0059).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Anderson to include the different medicaments for simultaneous inhalation are budesonide in the first blister and albuterol in the second blister as taught by Huang for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (See Huang: ¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (See Huang: ¶ 0059).
Regarding Claim 51, the modified device of Anderson discloses the dry powder inhaler wherein the medicament carriers comprise respective different medicament for simultaneous inhalation, at least including: fluticasone, formoterol, indacaterol, vilanterol, salmeterol, albuterol, budesonide, beclomethasone, ipratropium, umeclidinium, and glycopyrronium (See Shaikh: ¶¶ 0045-0054, 0062-0068, 0073, 0079, 00408-00463).
The modified device of Anderson does not specifically disclose the dry powder inhaler
Huang teaches an inhalation device for administering powdered pharmaceutical composition comprising at least two blisters (402; Fig. 5c, 5d) of a elongate blister strip (401; Fig. 5a-5d) containing the next medicament doses to the dispensing position (¶¶ 0038-0041, 0045), and wherein the different medicaments for simultaneous inhalation are a first medicament in a first blister (402; Fig. 5c, 5d) and formoterol in a second blister (402; Fig. 5c, 5d) such that the dry powder inhaler can be used for simultaneous inhalation of different medicaments from different blisters (¶¶ 0006-0007, 0013-0025, 0058, 0059, 0061, 0062) for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (¶ 0059).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Anderson to include the different medicaments for simultaneous inhalation are beclomethasone in a first blister and formoterol in a second blister as taught by Huang for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (See Huang: ¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (See Huang: ¶ 0059).
Regarding Claim 52, the modified device of Anderson discloses the dry powder inhaler wherein the medicament carriers comprise respective different medicament for simultaneous inhalation, at least including: fluticasone, formoterol, indacaterol, vilanterol, salmeterol, albuterol, budesonide, beclomethasone, ipratropium, umeclidinium, and glycopyrronium and co-formulation compatible components (See Shaikh: ¶¶ 0045-0054, 0062-0068, 0073, 0079, 00408-00463).
The modified device of Anderson does not specifically disclose the dry powder inhaler
Huang teaches an inhalation device for administering powdered pharmaceutical composition at least two blisters (402; Fig. 5c, 5d) of a elongate blister strip (401; Fig. 5a-5d) containing the next medicament doses to the dispensing position (¶¶ 0038-0041, 0045), and wherein the different medicaments for simultaneous inhalation are a first medicament in a first blister (402; Fig. 5c, 5d) and formoterol in a second blister (402; Fig. 5c, 5d) such that the dry powder inhaler can be used for simultaneous inhalation of different medicaments from different blisters (¶¶ 0006-0007, 0013-0025, 0058, 0059, 0061, 0062) for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (¶ 0059).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Anderson to include the different medicaments for simultaneous inhalation are two selected from beclomethasone, formoterol and glycopyrronium in the first blister third blister, the remaining medicament from beclomethasone, formoterol and glycopyrronium in the second blister as taught by Huang for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (See Huang: ¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (See Huang: ¶ 0059).
Regarding Claim 53, the modified device of Anderson discloses the dry powder inhaler wherein the medicament carriers comprise respective different medicament for simultaneous inhalation, at least including: fluticasone, formoterol, indacaterol, vilanterol, salmeterol, albuterol, budesonide, beclomethasone, ipratropium, umeclidinium, and glycopyrronium (See Shaikh: ¶¶ 0045-0054, 0062-0068, 0073, 0079, 00408-00463).
The modified device of Shaikh does not specifically disclose the dry powder inhaler
Huang teaches an inhalation device for administering powdered pharmaceutical composition at least two blisters (402; Fig. 5c, 5d) of a elongate blister strip (401; Fig. 5a-5d) containing the next medicament doses to the dispensing position (¶¶ 0038-0041, 0045), and wherein the different medicaments for simultaneous inhalation are indacaterol in a first blister (402; Fig. 5c, 5d) and a second medicament in a second blister (402; Fig. 5c, 5d) such that the dry powder inhaler can be used for simultaneous inhalation of different medicaments from different blisters (¶¶ 0006-0007, 0013-0025, 0058, 0059, 0061, 0062) for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (¶ 0059).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Anderson to include the different medicaments for simultaneous inhalation are indacaterol in the first blister and glycopyrronium in the second blister as taught by Huang for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (See Huang: ¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (See Huang: ¶ 0059).
Regarding Claim 54, the modified device of Shaikh discloses the dry powder inhaler wherein the medicament carriers comprise respective different medicament for simultaneous inhalation, at least including: fluticasone, formoterol, indacaterol, vilanterol, salmeterol, albuterol, budesonide, beclomethasone, ipratropium, umeclidinium, and glycopyrronium (See Shaikh: ¶¶ 0045-0054, 0062-0068, 0073, 0079, 00408-00463).
The modified device of Shaikh does not specifically disclose the dry powder inhaler
Huang teaches an inhalation device for administering powdered pharmaceutical composition at least two blisters (402; Fig. 5c, 5d) of a elongate blister strip (401; Fig. 5a-5d) containing the next medicament doses to the dispensing position (¶¶ 0038-0041, 0045), and wherein the different medicaments for simultaneous inhalation are fluticasone in a first blister (402; Fig. 5c, 5d) and a second medicament in a second blister (402; Fig. 5c, 5d) such that the dry powder inhaler can be used for simultaneous inhalation of different medicaments from different blisters (¶¶ 0006-0007, 0013-0025, 0058, 0059, 0061, 0062) for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (¶ 0059).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Anderson to include the different medicaments for simultaneous inhalation are fluticasone in the first blister and albuterol in the second blister as taught by Huang for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (See Huang: ¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (See Huang: ¶ 0059).
Regarding Claim 55, the modified device of Anderson discloses the dry powder inhaler wherein the medicament carriers comprise respective different medicament for simultaneous inhalation, at least including: fluticasone, formoterol, indacaterol, vilanterol, salmeterol, albuterol, budesonide, beclomethasone, ipratropium, umeclidinium, and glycopyrronium (See Shaikh: ¶¶ 0045-0054, 0062-0068, 0073, 0079, 00408-00463).
The modified device of Anderson does not specifically disclose the dry powder inhaler
Huang teaches an inhalation device for administering powdered pharmaceutical composition an indexing mechanism (416, 422; Fig. 2-4a) is arranged to move a single medicament carrier (401; Fig. 5c-5d), at least two blisters (402; Fig. 5c, 5d) of a elongate blister strip (401; Fig. 5a-5d) containing the next medicament doses to the dispensing position (¶¶ 0038-0041, 0045), and wherein the different medicaments for simultaneous inhalation are fluticasone in a first blister (402; Fig. 5c, 5d) and a second medicament in a second blister (402; Fig. 5c, 5d) such that the dry powder inhaler can be used for simultaneous inhalation of different medicaments from different blisters (¶¶ 0006-0007, 0013-0025, 0058, 0059, 0061, 0062) for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (¶ 0059).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Anderson to include the different medicaments for simultaneous inhalation are fluticasone in a first blister and salmeterol in a second blister as taught by Huang for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (See Huang: ¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (See Huang: ¶ 0059).
Regarding Claim 56, the modified device of Anderson discloses the dry powder inhaler wherein the medicament carriers comprise respective different medicament for simultaneous inhalation, at least including: fluticasone, formoterol, indacaterol, vilanterol, salmeterol, albuterol, budesonide, beclomethasone, ipratropium, umeclidinium, and glycopyrronium (See Shaikh: ¶¶ 0045-0054, 0062-0068, 0073, 0079, 00408-00463).
The modified device of Anderson does not specifically disclose the dry powder inhaler medicament carriers comprise respective different medicament for simultaneous inhalation which are fluticasone in a first blister and vilanterol in a second blister.
Huang teaches an inhalation device for administering powdered pharmaceutical composition at least two blisters (402; Fig. 5c, 5d) of a elongate blister strip (401; Fig. 5a-5d) containing the next medicament doses to the dispensing position (¶¶ 0038-0041, 0045), and wherein the different medicaments for simultaneous inhalation are fluticasone in a first blister (402; Fig. 5c, 5d) and a second medicament in a second blister (402; Fig. 5c, 5d) such that the dry powder inhaler can be used for simultaneous inhalation of different medicaments from different blisters (¶¶ 0006-0007, 0013-0025, 0058, 0059, 0061, 0062) for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (¶ 0059).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Anderson to include the different medicaments for simultaneous inhalation are fluticasone in a first blister and vilanterol in a second blister as taught by Huang for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (See Huang: ¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (See Huang: ¶ 0059).
Regarding Claim 57, the modified device of Anderson discloses the dry powder inhaler wherein the medicament carriers comprise respective different medicament for simultaneous inhalation, at least including: fluticasone, formoterol, indacaterol, vilanterol, salmeterol, albuterol, budesonide, beclomethasone, ipratropium, umeclidinium, and glycopyrronium (See Shaikh: ¶¶ 0045-0054, 0062-0068, 0073, 0079, 00408-00463).
The modified device of Anderson does not specifically disclose the dry powder inhaler
Huang teaches an inhalation device for administering powdered pharmaceutical composition at least two blisters (402; Fig. 5c, 5d) of a elongate blister strip (401; Fig. 5a-5d) containing the next medicament doses to the dispensing position (¶¶ 0038-0041, 0045), and wherein the different medicaments for simultaneous inhalation are vilanterol in a first blister (402; Fig. 5c, 5d) and umeclidinium in a second blister (402; Fig. 5c, 5d) such that the dry powder inhaler can be used for simultaneous inhalation of different medicaments from different blisters (¶¶ 0006-0007, 0013-0025, 0058, 0059, 0061, 0062) for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (¶ 0059).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Anderson to include the different medicaments for simultaneous inhalation are vilanterol in a first blister and umeclidinium in a second blister as taught by Huang for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (See Huang: ¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (See Huang: ¶ 0059).
Regarding Claim 58, the modified device of Anderson discloses the dry powder inhaler wherein the medicament carriers comprise respective different medicament for simultaneous inhalation, at least including: fluticasone, formoterol, indacaterol, vilanterol, salmeterol, albuterol, budesonide, beclomethasone, ipratropium, umeclidinium, and glycopyrronium and co-formulation compatible components (See Shaikh: ¶¶ 0045-0054, 0062-0068, 0073, 0079, 00408-00463).
The modified device of Anderson does not specifically disclose the dry powder inhaler
Huang teaches an inhalation device for administering powdered pharmaceutical composition at least two blisters (402; Fig. 5c, 5d) of a elongate blister strip (401; Fig. 5a-5d) containing the next medicament doses to the dispensing position (¶¶ 0038-0041, 0045), and wherein the different medicaments for simultaneous inhalation are a first medicament in a first blister (402; Fig. 5c, 5d) and vilanterol in a second blister (402; Fig. 5c, 5d) such that the dry powder inhaler can be used for simultaneous inhalation of different medicaments from different blisters (¶¶ 0006-0007, 0013-0025, 0058, 0059, 0061, 0062) for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (¶ 0059).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Anderson to include the different medicaments for simultaneous inhalation are two selected from fluticasone, vilanterol and umeclidinium in a first blister, the remaining medicament from fluticasone, vilanterol and umeclidinium in a second blister as taught by Huang for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (See Huang: ¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (See Huang: ¶ 0059).
Regarding Claim 59, the modified device of Anderson discloses the dry powder inhaler wherein the medicament carriers comprise respective different medicament for simultaneous inhalation, at least including: fluticasone, formoterol, indacaterol, vilanterol, salmeterol, albuterol, budesonide, beclomethasone, ipratropium, umeclidinium, and glycopyrronium (See Shaikh: ¶¶ 0045-0054, 0062-0068, 0073, 0079, 00408-00463).
The modified device of Anderson does not specifically disclose the dry powder inhaler
Huang teaches an inhalation device for administering powdered pharmaceutical composition at least two blisters (402; Fig. 5c, 5d) of a elongate blister strip (401; Fig. 5a-5d) containing the next medicament doses to the dispensing position (¶¶ 0038-0041, 0045), and wherein the different medicaments for simultaneous inhalation are a first medicament in a first blister (402; Fig. 5c, 5d) and formoterol in a second blister (402; Fig. 5c, 5d) such that the dry powder inhaler can be used for simultaneous inhalation of different medicaments from different blisters (¶¶ 0006-0007, 0013-0025, 0058, 0059, 0061, 0062) for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (¶ 0059).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Anderson to include the different medicaments for simultaneous inhalation are glycopyrronium in a first blister and formoterol in a second blister as taught by Huang for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (See Huang: ¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (See Huang: ¶ 0059).
Regarding Claim 60, the modified device of Anderson discloses the dry powder inhaler wherein the medicament carriers comprise respective different medicament for simultaneous inhalation, at least including: fluticasone, indacaterol, vilanterol, salmeterol, albuterol, budesonide, beclomethasone, ipratropium, umeclidinium, and glycopyrronium and co-formulation compatible components (See Shaikh: ¶¶ 0045-0054, 0062-0068, 0073, 0079, 00408-00463).
The modified device of Anderson does not specifically disclose the dry powder inhaler
Huang teaches an inhalation device for administering powdered pharmaceutical composition at least two blisters (402; Fig. 5c, 5d) of a elongate blister strip (401; Fig. 5a-5d) containing the next medicament doses to the dispensing position (¶¶ 0038-0041, 0045), and wherein the different medicaments for simultaneous inhalation are a first medicament in a first blister (402; Fig. 5c, 5d) and formoterol in a second blister (402; Fig. 5c, 5d) such that the dry powder inhaler can be used for simultaneous inhalation of different medicaments from different blisters (¶¶ 0006-0007, 0013-0025, 0058, 0059, 0061, 0062) for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (¶ 0059).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Anderson to include the different medicaments for simultaneous inhalation are two selected from budesonide, formoterol and glycopyrronium in the first blister third blister, the remaining medicament from budesonide, formoterol and glycopyrronium in the second blister as taught by Huang for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (See Huang: ¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (See Huang: ¶ 0059).
Regarding Claim 61, the modified device of Anderson discloses the dry powder inhaler wherein the medicament carriers comprise respective different medicament for simultaneous inhalation, at least including: fluticasone, indacaterol, vilanterol, salmeterol, albuterol, budesonide, beclomethasone, ipratropium, umeclidinium, and glycopyrronium (See Shaikh: ¶¶ 0045-0054, 0062-0068, 0073, 0079, 00408-00463).
The modified device of Anderson does not specifically disclose the dry powder inhaler
Huang teaches an inhalation device for administering powdered pharmaceutical composition at least two blisters (402; Fig. 5c, 5d) of a elongate blister strip (401; Fig. 5a-5d) containing the next medicament doses to the dispensing position (¶¶ 0038-0041, 0045), and wherein the different medicaments for simultaneous inhalation are a first medicament in a first blister (402; Fig. 5c, 5d) and formoterol in a second blister (402; Fig. 5c, 5d) such that the dry powder inhaler can be used for simultaneous inhalation of different medicaments from different blisters (¶¶ 0006-0007, 0013-0025, 0058, 0059, 0061, 0062) for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (¶ 0059).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Anderson to include the different medicaments for simultaneous inhalation are fluticasone in a first blister and formoterol in a second blister as taught by Huang for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (See Huang: ¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (See Huang: ¶ 0059).
Regarding Claim 62, the modified device of Anderson discloses the dry powder inhaler wherein the medicament carriers comprise respective different medicament for simultaneous inhalation, at least including: fluticasone, formoterol, indacaterol, vilanterol, salmeterol, albuterol, budesonide, beclomethasone, ipratropium, umeclidinium, and glycopyrronium (See Shaikh: ¶¶ 0045-0054, 0062-0068, 0073, 0079, 00408-00463).
The modified device of Anderson does not specifically disclose the dry powder inhaler
Huang teaches an inhalation device for administering powdered pharmaceutical composition at least two blisters (402; Fig. 5c, 5d) of a elongate blister strip (401; Fig. 5a-5d) containing the next medicament doses to the dispensing position (¶¶ 0038-0041, 0045), and wherein the different medicaments for simultaneous inhalation are a first medicament in a first blister (402; Fig. 5c, 5d) and a second medicament in a second blister (402; Fig. 5c, 5d) such that the dry powder inhaler can be used for simultaneous inhalation of different medicaments from different blisters (¶¶ 0006-0007, 0013-0025, 0058, 0059, 0061, 0062) for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (¶ 0059).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Anderson to include the different medicaments for simultaneous inhalation are ipratropium in the first blister and albuterol in the second blister as taught by Huang for the purpose of enabling the user to inhale two types of drug powder at the same time through one outlet and reducing the difficulty of injection molding and manufacturing of the device, and the difficulty of assembly of the device (See Huang: ¶ 0058) or allowing the user to inhale two types of drug powder from one pocket and one outlet at the same time (See Huang: ¶ 0059).
Response to Arguments
Applicant’s arguments regarding the new limitations with respect to independent claims 1 and 63 have been considered but are moot because the arguments do not apply to the rejection in the previous office action (e.g., do not apply to claim limitations previously rejected). All arguments directed to new limitations in the amended claims are addressed in the 35 U.S.C. 103 rejection Anderson in view of Shaikh, shown above.
Applicant's arguments filed February 11, 2026 have been fully considered but they are not persuasive. Regarding the limitation “"the first gear wheel is provided with four resilient pawls at 90 degree intervals and the second gear wheel is provided with four teeth at 90 degree intervals, and movement of the mouthpiece cover from the second position to the third position encloses an angle about the rotation axis of 90 degrees." recited in independent claim 1 and 63, Examiner refers Applicant to the Patent Trail and Appeal Board decision for previously co-pending Application No. 17/873,662 ( now abandoned) of September 22, 2025.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785