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 .
Status of the Claims
This Office Action is in responsive to the preliminary amendment filed on 6/17/2024. As directed by the Preliminary amendment, claims 35-37, 39, 41, and 43-45 were amended, and claims 1-31 and 46-51 were cancelled. Thus, claims 32-45 are currently pending in this application.
Specification/Abstract
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 it recites “the present invention relates to” in line 1 which is a phrase that can be implied. Additionally, it has the form and legal phraseology of a claim, as it uses the phrase “comprising” as well as multiple semicolons to create one long sentence. 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 32-45 are objected to because of the following informalities:
Claim 32 recites “the manifold” in line 1, and is suggested to read --the airway manifold-- in order to more clearly reference how this limitation was originally claimed.
Claims 33-45 each recite “An airway manifold according to claim” and are suggested to read --The airway manifold according to claim-- in order to ensure proper antecedent basis.
Claim 37 recites “the manifold” in line 2, and is suggested to read --the airway manifold-- in order to more clearly reference how this limitation was originally claimed.
Claim 38 recites “any of claims 37” in line 1, and is suggested to read --claim 37-- in order to be grammatically correct.
Claim 39 recites “each chamber” in line 2, and is suggested to read --each chamber of the first and second chambers-- in order to more clearly reference how these limitations were originally claimed and to provide proper antecedent basis.
Claim 40 recites “any of claim 39” in line 1, and is suggested to read --claim 39-- in order to be grammatically correct.
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 34-36, 38-40, and 42-45 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 34 recites the limitations "the volume of the first flow path" in lines 1-2 and "the volume of the second flow path" in line 2. There is insufficient antecedent basis for these limitations in the claim.
Claim 35 recites the limitations "the internal form of the first flow path" in line 2 and "the internal form of the second flow path" in lines 2-3. There is insufficient antecedent basis for these limitations in the claim.
Claim 36 recites the limitations "the surface finish of the first flow path" in line 2 and "the surface finish of the second flow path" in lines 2-3. There is insufficient antecedent basis for these limitations in the claim.
Regarding claim 38, the limitation “three or more chambers” in lines 1-2 is confusing, as it is unclear whether this limitation is meant to include or be separate from “first and second chambers” in claim 37. For the purposes of examination, it will be interpreted as including the first and second chambers.
Claim 42 recites the limitations "the size of the first manifold inlet" in lines 1-2 and "the size of the second manifold inlet" in line 2. There is insufficient antecedent basis for these limitations in the claim.
Claim 43 recites the limitations "the angle of the first manifold inlet" in line 2 and "the angle of the second manifold inlet" in lines 2-3. There is insufficient antecedent basis for these limitations in the claim.
Claim 44 recites the limitations "the surface finish of the first manifold inlet" in line 2 and "the surface finish of the second manifold inlet" in lines 2-3. There is insufficient antecedent basis for these limitations in the claim.
Regarding claim 45, the limitation “An inhaler device” in line 1 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “an inhaler device” in claim 32. For the purposes of examination, they will be interpreted as the same limitation.
Any remaining claims are rejected based on their dependency on a rejected base claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 45 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 45, this claim fails to further limit the subject matter of claim 32 from which it depends, as claim 32 already recites “an inhaler device” and “an airway manifold according to claim 32”.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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.
Claims 32-35, 37-43, and 45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Makiej, Jr. (US 5,002,048).
Regarding claim 32, Makiej discloses an airway manifold for an inhaler device (inhalation device with L-shaped housing and mouthpiece) (Fig. 1; abstract), the manifold comprising first and second manifold inlets for receiving first and second medicaments (L-shaped housing 12 has first and second chambers 14, 16, each with space towards the bottom to receive valve discharge assemblies 26, 28 which discharge medicine) (Fig. 1; col. 2 lines 6-24), and a single outlet in communication with a mouthpiece (bottom opening of L-shaped housing 12, just past the end of dividing wall 34, that connects to a mouthpiece) (Fig. 1; col. 2 lines 18-20, 32-36); wherein the manifold provides a first flow path between the first manifold inlet and the single outlet (flow path in first chamber 14 between its top opening and the opening to the mouthpiece) (Fig. 1; col. 2 lines 6-20, 32-36), and a second flow path between the second manifold inlet and the single outlet (flow path in second chamber 16 between its top opening and the opening to the mouthpiece) (Fig. 1; col. 2 lines 6-20, 32-36), and wherein the manifold is designed or configured to provide a difference in flow through the first and second flow paths (first and second chambers 14, 16 have their top openings at different heights and have the distance traveled for the respective aerosolized medications 30, 31 to the mouthpiece as different, hence there is a difference in their respective flows) (Fig. 1; col. 2 lines 18-31).
Regarding claim 33, Makiej discloses wherein the first and second flow paths are asymmetrical (the spaces inside the first and second chambers 14, 16 through which air flows are asymmetrical to each other) (Fig. 1).
Regarding claim 34, as best understood, Makiej discloses wherein the volume of the first flow path is different from the volume of the second flow path (the space inside the second chambers 16 is longer than that of the first chamber 14, and so its volume is greater) (Fig. 1).
Regarding claim 35, as best understood, Makiej discloses wherein the internal form of the first flow path is different from the internal form of the second flow path (the space inside the second chambers 16 is differently internally shaped in comparison to the first chamber 14) (Fig. 1).
Regarding claim 37, Makiej discloses wherein the manifold is at least partly split into first and second chambers by a dividing wall, wherein the first chamber provides the first flow path and the second chamber provides the second flow path (dividing wall 34 splits the L-shaped housing 12 into the first and second chambers 14, 16, each of which having their own flow path) (Fig. 1; col. 2 lines 6-20, 32-36).
Regarding claim 38, as best understood, Makiej discloses wherein three or more chambers are provided (the inhalation device can be for two or more aerosol containers and so can have at least three; each aerosol container has its own opening into the housing with space to receive it) (Fig. 1; abstract; col. 2 lines 6-12; claim 1).
Regarding claim 39, as best understood, Makiej discloses wherein a separate bypass air inlet is provided into each chamber (each of the first and second chambers 14, 16 has an inlet extending down along its respective canister 18, 20 towards the valve discharge assemblies 26, 28, these inlets being open to the air in the ambient environment) (Fig. 1; col. 2 lines 6-20).
Regarding claim 40, Makiej discloses wherein the bypass air inlets are asymmetrical (due to the asymmetrically sloped shape of the L-shaped housing 12, the inlets for the first and second chambers 14, 16 have differing heights and so are asymmetrical as they get shorter from left to right) (Fig. 1; col. 2 lines 23-27).
Regarding claim 41, Makiej discloses wherein the first and second manifold inlets are asymmetrical (the bottom space of the first and second chambers 14, 16 for the valve discharge assemblies 26, 28 are asymmetrical) (Fig. 1).
Regarding claim 42, as best understood, Makiej discloses wherein the size of the first manifold inlet is different from the size of the second manifold inlet (the bottom space of the first chamber 14 for the valve discharge assembly 26 is smaller than the bottom space of the second chamber 16 for the valve discharge assembly 28) (Fig. 1).
Regarding claim 43, as best understood, Makiej discloses wherein the angle of the first manifold inlet is different from the angle of the second manifold inlet (the bottom space of the first chamber 14 for the valve discharge assembly 26 is at a different angle relative to canister 18 than the bottom space of the second chamber 16 for the valve discharge assembly 28 relative to canister 18) (Fig. 1).
Regarding claim 45, as best understood, Makiej discloses an inhaler device comprising an airway manifold according to claim 32 (see 35 U.S.C. 102(a)(1) rejection of claim 1 in view of Makiej as detailed above).
Claims 32-35, 37-43, and 45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (US 2020/0360631 A1).
Regarding claim 32, Li discloses an airway manifold for an inhaler device (dry powder inhaler with air inlet channels and an air outlet channel) (abstract), the manifold comprising first and second manifold inlets for receiving first and second medicaments (capsule chambers 1a, 1b with intake ducts 14 that each hold capsules with different pharmaceutically active powder ingredients) (Figs. 13-14, 17-18; para. [0007]; para. [0151]), and a single outlet in communication with a mouthpiece (screen cover 15 below outlet duct 11 covering both capsule chambers) (Figs. 13-14, 17-18; para. [0151]); wherein the manifold provides a first flow path between the first manifold inlet and the single outlet (air flows from intake duct 14 to capsule chamber 1a to the screen cover 15 and then outlet duct 11) (Figs. 13-14, 17-18; para. [0151]; para. [0153]), and a second flow path between the second manifold inlet and the single outlet (air flows from intake duct 14 to the capsule chamber 1b to the screen cover 15 and then outlet duct 11) (Figs. 13-14, 17-18; para. [0151]; para. [0153]), and wherein the manifold is designed or configured to provide a difference in flow through the first and second flow paths (structural characteristic of the intake ducts 13, intake ducts 14, and/or outlet duct 11 can be adjusted such that different aerodynamic parameters can be set for each capsule chamber 1, such as different air flow rates) (Figs. 13-14, 17-18; paras. [0177-0178]).
Regarding claim 33, Li discloses wherein the first and second flow paths are asymmetrical (structural characteristics such as the size and opening angle of the respective intake ducts 14 for each capsule chamber 1 can be different from each other, and so they would be asymmetrical relative to each other) (Figs. 13-14, 17-18; paras. [0177-0178]).
Regarding claim 34, as best understood, Li discloses wherein the volume of the first flow path is different from the volume of the second flow path (structural characteristics such as the size of the respective intake ducts 14 for each capsule chamber 1 can be different from each other, and so they would have different volumes) (Figs. 13-14, 17-18; paras. [0177-0178]).
Regarding claim 35, as best understood, Li discloses wherein the internal form of the first flow path is different from the internal form of the second flow path (structural characteristics such as the size, position, and opening angle of the respective intake ducts 14 for each capsule chamber 1 can be different from each other, and so they would be of different internal forms relative to each other) (Figs. 13-14, 17-18; paras. [0177-0178]).
Regarding claim 37, Li discloses wherein the manifold is at least partly split into first and second chambers by a dividing wall, wherein the first chamber provides the first flow path and the second chamber provides the second flow path (unlabeled wall between the capsule chambers 1, such that the air flow paths for each are separate until they meet in the outlet duct 11) (Figs. 13-14, 17-18; para. [0151]; para. [0153]).
Regarding claim 38, as best understood, Li discloses wherein three or more chambers are provided (first, second, and third capsule chambers 1a, 1b, 1c) (Fig. 18; para. [0175]).
Regarding claim 39, as best understood, Li discloses wherein a separate bypass air inlet is provided into each chamber (each capsule chamber 1 has its own deflected intake duct 13) (Figs. 13-14, 17-18; para. [0155]).
Regarding claim 40, Li discloses wherein the bypass air inlets are asymmetrical (structural characteristics such as the size and opening angle of the respective deflected intake ducts 13 for each capsule chamber 1 can be different from each other, and so they would be asymmetrical relative to each other) (Figs. 13-14, 17-18; para. [0155]; paras. [0177-0178]).
Regarding claim 41, Li discloses wherein the first and second manifold inlets are asymmetrical (structural characteristics such as the size and opening angle of the respective intake ducts 14 for each capsule chamber 1 can be different from each other, and so they would be asymmetrical relative to each other) (Figs. 13-14, 17-18; paras. [0177-0178]).
Regarding claim 42, as best understood, Li discloses wherein the size of the first manifold inlet is different from the size of the second manifold inlet (structural characteristics such as the size of the respective intake ducts 14 for each capsule chamber 1 can be different from each other) (Figs. 13-14, 17-18; paras. [0177-0178]).
Regarding claim 43, as best understood, Li discloses wherein the angle of the first manifold inlet is different from the angle of the second manifold inlet (structural characteristics such as the position and opening angle of the respective intake ducts 14 for each capsule chamber 1 can be different from each other) (Figs. 13-14, 17-18; paras. [0177-0178]).
Regarding claim 45, as best understood, Li discloses an inhaler device comprising an airway manifold according to claim 32 (see 35 U.S.C. 102(a)(1) rejection of claim 1 in view of Li as detailed above).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 36 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Li as applied to claims 32 and 41 above, and further in view of Gieschen et al. (US 2001/0027790 A1).
Regarding claim 36, as best understood, Li discloses the invention as previously claimed, but does not disclose wherein the surface finish of the first flow path is different from the surface finish of the second flow path.
However, Li does teach the structural characteristics of the intake ducts 13, 14 for each capsule chamber 1 can be different from each other in order to give different air flow rates to affect the particle distribution from each capsule (Li; Figs. 13-14, 17-18; paras. [0177-0178]). Moreover, Gieschen teaches a dry powder inhaler (Gieschen; abstract) wherein the inlets can have smooth or rough surface finishes on their walls as structural characteristics to control flow resistance and flow pattern (Gieschen; para. [0101]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Li surface finishes such that the surface finish of the first flow path is different from the surface finish of the second flow path, as taught by Li and Gieschen, for the purpose of providing an additional and/or alternative means of controlling the air flow resistances and flow patterns in each flow path (Li, paras. [0177-0178]; Gieschen, para. [0101]).
Regarding claim 44, as best understood, the modified Li teaches wherein the surface finish of the first manifold inlet is different from the surface finish of the second manifold inlet (structural characteristics such as the Gieschen smooth or rough surface walls of the respective Li intake ducts 14 for each capsule chamber 1 can be different from each other) (Li, Figs. 13-14, 17-18, paras. [0177-0178]; Gieschen, para. [0101]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2006/0237010 A1 by De Boer et al. is considered to be relevant as it discloses a dry powder inhaler with multiple channels, inlets, and air flow paths.
US 2017/0172938 A1 by Nielsen is considered to be relevant as it discloses an oral delivery system wherein separate fluid conduits can be different sizes to administer components differently.
US 2021/0128895 A1 by Tong et al. is considered to be relevant as each component is delivered via a differently angled flow path.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE M PINDERSKI whose telephone number is (571)272-7032. The examiner can normally be reached Monday-Friday 7:00-4:00.
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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