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
Acknowledgement is made to Applicant’s claim to priority to Nation Stage App. PCT/US21/14604 filed January 22, 2021; and to Provisional App. No. 62/964,208 filed January 22, 2020.
Status of Claims
This Office Action is responsive to the amendment filed on November 11, 2025. As directed by the amendment: claims 1-3, 6, 10, 24, and 25 have been amended; claims 29-34 have been cancelled; and claims 35-43 have been added. Thus, claims 1-28 and 35-43 are presently pending in this application.
Applicant’s election without traverse of Group I, Claims 1-23 in the reply filed on November 11, 2025 is acknowledged.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “an air jet DPI arranged inline between the gas source and the patient interface and configured to introduce an aerosol to gas from the gas source before the gas reaches the patient interface”, of claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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: “volume limiter” in claim 1; “release mechanism” in claim 25
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 10, and 39, and claims 2-9, 11-28, and 40-43 by dependency, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “an air jet DPI arranged inline between the gas source and the patient interface and configured to introduce an aerosol to gas from the gas source before the gas reaches the patient interface”, ln 7-9. Applicant’s invention is directed to a gas source that delivers a volume of gas that a fine solid particle is entertained within and delivered to a patient interface. The limitation “configured to introduce an aerosol to gas from the gas source” requires the air jet DPI to have a suspension of fine solid or liquid particles in gas (i.e. the definition of aerosol) to be introduced to the gas from the gas source. The instant disclosure fails to describe or depict a secondary flow of gas with a suspension of fine solid or liquid particles entrained therein.
Similar rational is applied to independent claims 10 and 39.
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 1, 10, and 39, and claims 2-9, 11-28, and 40-43 by dependency, 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 1 recites “an air jet DPI arranged inline between the gas source and the patient interface and configured to introduce an aerosol to gas from the gas source before the gas reaches the patient interface”, ln 7-9. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “aerosol” in claim 1, ln 8 is used by the claim to mean “fine solid particles” while the accepted meaning is “a suspension of fine solid or liquid particles in gas.” The term is indefinite because the specification does not clearly redefine the term. Specifically, Applicant’s invention is directed to a gas source that delivers a volume of gas that a fine solid particle is entertained within and delivered to a patient interface. Therefore, for the purpose of this Office Action the limitation “an air jet DPI arranged inline between the gas source and the patient interface and configured to introduce an aerosol to gas from the gas source before the gas reaches the patient interface” has been interpreted as --an air jet DPI arranged inline between the gas source and the patient interface and configured to introduce fine solid particles to the gas volume from the gas source to form an aerosol before the gas reaches the patient interface--.
Similar rational is applied to independent claims 10 and 39.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 4-9, 8, 17-18, 39-40, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (U.S. Pub. No. 2018/0056022; hereinafter: “Liu”) in view of Baker et al. (U.S. Pub. No. 2009/0281483; hereinafter: “Baker”).
Regarding Claim 1, Liu discloses an air jet dry powder inhaler (DPI) system for infants, comprising a positive pressure gas source (2, 9, 37; Fig. 2, 4, 5, 8, 9) comprising a volume limiter (10, 11, 12, 20; Fig. 4, 5) that is adjustable to allow precise control over a gas volume to be delivered to an infant (¶¶ 0048-0053); ; and an air jet DPI (1, 3, 4, 5, 8, 31; Fig. 2, 2.1, 8, 9) arranged inline between the gas source and the patient interface (Fig. 2) and configured to introduce fine solid particles (1, 39; Fig. 2, 8, 9; ¶¶ 0049, 0056-0064) to the gas volume from the gas source to form an aerosol before the gas reaches the patient interface (¶¶ 0048-0052, 0056-0064).
Liu does not specifically disclose the air jet DPI system wherein the patient interface configured to form an airtight seal with one or both nostrils of the infant; wherein the air jet DPI system is configured to have airtight communication with lungs of the infant when the patient interface is forming an airtight seal with one or both of the infant's nostrils and all other pulmonary orifices are closed.
Baker teaches a DPI (2; Fig. 3-5A, 6) comprising a patient interface (18; Fig. 3-6) configured to form an airtight seal with one or both nostrils of an infant (¶¶ 0010-0013, 0167-0169); wherein the air jet DPI system is configured to have airtight communication with lungs of the infant when the patient interface is forming an airtight seal with one or both of the infant's nostrils and all other pulmonary orifices are closed (¶¶ 0010-0013, 0110, 0165-0169, 0288-0291, 0290, 0300-0318) for the purpose of allowing for the application of an inward force to gently seal against the nostril at variety of positions (¶ 0304).
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 air jet DPI system of Liu to include the patient interface configured to form an airtight seal with one or both nostrils of the infant; wherein the air jet DPI system is configured to have airtight communication with lungs of the infant when the patient interface is forming an airtight seal with one or both of the infant's nostrils and all other pulmonary orifices are closed as taught by Baker for the purpose of allowing for the application of an inward force to gently seal against the nostril at variety of positions (See Baker: ¶ 0304).
Regarding Claims 4-5, the modified device of Liu discloses the air jet DPI system, shown above.
The modified device of Liu does not specifically disclose the air jet DPI system discloses the wherein a total air space volume of the air jet DPI system is 2 ml or less.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to set a total air space volume of the air jet DPI system to 2 ml or less in the modified device of Liu because Applicant has not disclosed that setting the total air space volume of the air jet DPI system to 2 ml or less provides an advantage, is used for a particular purpose, or solves a stated problem (See Instant Spec Pg. 2, ln 3-22). One of ordinary skill in the art, furthermore, would have expected the total air space volume of the air jet DPI system of the modified device of Liu, and Applicant’s total air space volume of the air jet DPI system, to perform equally well because both mechanisms perform the same function of delivering an aerosol to the patient interface.
Therefore, it would have been prima facie obvious to modify the modified device of Liu to obtain the invention as specified in claims 4-5 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired delivering of the aerosol to the patient interface and thus fails to patentably distinguish over the prior art of the modified device of Liu.
Regarding Claim 6, the modified device of Liu discloses the air jet DPI system wherein the positive pressure gas source is configured to deliver the gas volume to be delivered infant
Regarding Claim 9, the modified device of Liu discloses the air jet DPI system wherein the gas source is a compressed gas source (See Liu: ¶¶ 0051-0053, 0070).
Regarding Claims 17-18, the modified device of Liu discloses the air jet DPI system wherein the air jet DPI comprises an elongate aerosolization chamber (3, 8; Fig. 2) with a longitudinal axis (A, Fig. A annotated below), and one or more inlets (B, Fig. A annotated below and one or more outlets (C, Fig. A annotated below) all positioned at an upper longitudinal segment (D, Fig. A annotated below) of the aerosolization chamber.
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Figure A, Adapted from Figure 2 of Liu.
The modified device of Liu does not explicitly disclose the air jet DPI system discloses the, wherein the upper longitudinal segment extends no more than 25% of a length of the aerosolization chamber.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to form the upper longitudinal segment extends no more than 25% of a length of the aerosolization chamber in the modified device of Liu because Applicant has not disclosed that forming the upper longitudinal segment extends no more than 25% of a length of the aerosolization chamber provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, the instant specification provides forming the upper longitudinal segment extends no more than 25% of a length of the aerosolization chamber as exemplary (Pg. 2, ln 29 to Pg. 3, ln 2). One of ordinary skill in the art, furthermore, would have expected forming the upper longitudinal segment extending no more than 25% of a length of the aerosolization chamber of the modified device of Liu, and Applicant’s, to perform equally well because both mechanisms perform the same function of delivering an aerosol to the patient interface.
Therefore, it would have been prima facie obvious to modify the modified device of Liu to obtain the invention as specified in claims 17-18 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired delivering of the aerosol to the patient interface and thus fails to patentably distinguish over the prior art of the modified device of Liu.
Regarding Claim 39, Liu discloses a method of using an air jet dry powder inhaler (DPI) system for infants, comprising adjusting a volume limiter on a gas source (2, 9, 37; Fig. 2, 4, 5, 8, 9) to a gas volume (10, 11, 12, 20; Fig. 4, 5) to be delivered depending on the specific infant being treated (¶¶ 0048-0053); a patient interface (6, 34; Fig. 2, 8, 9); introducing, by an air jet DPI (1, 3, 4, 5, 8, 31; Fig. 2, 2.1, 8, 9) arranged inline between the gas source and the patient interface (Fig. 2), a fine solid particles (1, 39; Fig. 2, 8, 9; ¶¶ 0049, 0056-0064) to the gas volume from the gas source to form an aerosol before the gas reaches the patient interface (¶¶ 0048-0052, 0056-0064) and delivering in a single actuation of the gas source both the aerosol and the gas volume to be delivered to the infant using positive pressure (¶¶ 0048-0052, 0056-0064).
Liu does not specifically disclose the method comprising forming, by the patient interface, an airtight seal with one or both nostrils of the infant; wherein the air jet DPI system is configured to have airtight communication with lungs of the infant when the patient interface is forming an airtight seal with one or both of the infant's nostrils and all other pulmonary orifices are closed.
Baker teaches a DPI (2; Fig. 3-5A, 6) comprising a patient interface (18; Fig. 3-6) configured to form an airtight seal with one or both nostrils of an infant (¶¶ 0010-0013, 0167-0169); wherein the air jet DPI system is configured to have airtight communication with lungs of the infant when the patient interface is forming an airtight seal with one or both of the infant's nostrils and all other pulmonary orifices are closed (¶¶ 0010-0013, 0110, 0165-0169, 0288-0291, 0290, 0300-0318) for the purpose of allowing for the application of an inward force to gently seal against the nostril at variety of positions (¶ 0304).
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 method of Liu to include forming, by the patient interface, the airtight seal with one or both nostrils of the infant; wherein the air jet DPI system is configured to have airtight communication with lungs of the infant when the patient interface is forming an airtight seal with one or both of the infant's nostrils and all other pulmonary orifices are closed as taught by Baker for the purpose of allowing for the application of an inward force to gently seal against the nostril at variety of positions (See Baker: ¶ 0304).
Regarding Claim 40, the modified method of Liu discloses the method wherein the aerosol and gas volume to be delivered are delivered at a delivery flow rate of 1.2 to 5 LPM (See Liu: ¶¶ 0063, 0064, 0125).
Regarding Claim 43, the modified method of Liu discloses the method wherein the gas volume to be delivered is delivered in one second or less (See Liu: ¶ 0130).
Claim(s) 2, 3, 7 are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Baker as applied to claim 1 above, and further in view of Sievers et al. (U.S. 2008/0035143; hereinafter: “Sievers”).
Regarding Claims 2-3, the modified device of Liu discloses the air jet DPI system, shown above.
The modified device of Liu does not specifically disclose the air jet DPI system discloses the wherein the gas volume to be delivered
Sievers teaches a positive pressure gas source (20; Fig. 1, 2) having a syringe with a gas volume to be delivered of 10 ml or less (¶ 0034) for the purpose of providing a suitable volume (¶ 0034).
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 Liu to include the gas volume to be delivered is a maximum of 10 ml or less as taught by Sievers for the purpose of providing a suitable volume (See Sievers: ¶ 0034).
Regarding Claim 7, the modified device of Liu discloses the air jet DPI system, shown above.
The modified device of Liu does not specifically disclose the air jet DPI system discloses the wherein the gas source comprises one or more hand actuated syringes.
Sievers teaches a positive pressure gas source (20; Fig. 1, 2) having a gas source comprises one or more hand actuated syringes (¶ 0034) for the purpose of providing a human-powered compressible gas source (¶ 0034).
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 Liu to include the gas source comprising the hand actuated syringe as taught by Sievers for the purpose of providing a human-powered compressible gas source (See Sievers: ¶ 0034).
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Baker in view of Sievers as applied to claim 7 above, and further in view of Galli (WO 9318812 A1).
Regarding Claim 8, the modified device of Liu discloses the air jet DPI system, shown above.
The modified device of Liu does not specifically disclose the air jet DPI system discloses the wherein the one or more hand actuated syringes comprise one or more springs.
Galli teaches a powder jet dispenser (Fig. 1-3) comprising a syringe (3, 5, 8; Fig. 1-4) having a spring (15; Fig. 1-3; Pg. 8, ln 5-14; Pg. 12, ln 38 to Pg. 13, ln 7) for the purpose of returning the syringe to the rest or start position (Pg. 12, ln 38 to Pg. 13, ln 7).
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 Liu to include the hand actuated syringe comprises the spring as taught by Galli for the purpose of returning the syringe to the rest or start position (See Galli: Pg. 12, ln 38 to Pg. 13, ln 7).
Claim(s) 12 and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Baker as applied to claim 1 above, and further in view of Longest et al. (U.S. Pub. No. 2015/0107589; hereinafter: “Longest”).
Regarding Claim 12, the modified device of Liu discloses the air jet DPI system, shown above.
The modified device of Liu does not specifically disclose the air jet DPI system wherein a cannula of the patient interface has a gradually expanding interior over a length of 40-80 mm.
Longest teaches a DPI (300; Fig. 3) comprising a patient interface (A, Fig. B annotated below) having a cannula (310; Fig. 3) having a gradually expanding interior (B, Fig. B annotated below; ¶¶ 0040, 0041) for the purpose of utilizing the Bernoulli effect (¶¶ 0040, 0041).
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Figure B, Adapted from Figure 3 of Longest.
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 Liu to include the cannula of the patient interface has a gradually expanding interior as taught by Longest for the purpose of utilizing the Bernoulli effect (See Longest: ¶¶ 0040, 0041).
The modified device of Liu does not explicitly disclose the air jet DPI system wherein the cannula of the patient interface has a length of 40-80 mm.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to set the length of the cannula as 40-80 mm in the modified device of Liu because Applicant has not disclosed that the length of the cannula being 40-80 mm provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, the instant specification provides the length of the cannula as exemplary (Pg. 8, ln 21-23). One of ordinary skill in the art, furthermore, would have expected the patient interface of the modified device of Liu, and Applicant’s patient interface, to perform equally well because both mechanisms perform the same function of delivering the dry powder to the infant.
Therefore, it would have been prima facie obvious to modify the modified device of Liu to obtain the invention as specified in claim 12 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired delivery of the dry powder to the infant and thus fails to patentably distinguish over the modified device of Liu.
Regarding Claim 19, the modified device of Liu discloses the air jet DPI system, shown above.
The modified device of Liu does not specifically disclose the air jet DPI system wherein the patient interface comprises a 3D rod array arranged such that an aerosol jet entering the patient interface must pass through the 3D rod array before exiting the patient interface.
Longest teaches a DPI (400; Fig. 4a) comprising a patient interface (403, 404; Fig. 4a) comprises a 3D rod array (404; Fig. 3) arranged such that an aerosol jet entering the patient interface must pass through the 3D rod array before exiting the patient interface (¶¶ 0032-0035, 0042, 0046, 0047) for the purpose of improving dispersion and creating higher fine particle fractions (¶¶ 0006, 0032).
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 Liu to include the patient interface comprises a 3D rod array arranged such that an aerosol jet entering the patient interface must pass through the 3D rod array before exiting the patient interface as taught by Longest for the purpose of improving dispersion and creating higher fine particle fractions (¶¶ 0006, 0032).
Regarding Claim 20, the modified device of Liu discloses the air jet DPI system wherein the 3D rod array comprises a plurality of rows of rods which extend between opposite walls of a lumen of the patient interface (See Longest: ¶¶ 0011, 0032-0035, 0042, 0046, 0047).
Regarding Claim 21, the modified device of Liu discloses the air jet DPI system wherein the 3D rod array spans less than an entire cross-sectional distance of the lumen between the at least one inlet and the one or more exit orifices in a direction perpendicular to a long axis of the rods of the 3D rod array (See Longest: Fig. 4a; ¶¶ 0011, 0032-0035, 0042, 0046, 0047).
Regarding Claims 22-23, the modified device of Liu discloses the air jet DPI system, shown above.
The modified device of Liu does not explicitly disclose the air jet DPI system wherein the 3D rod array is spaced 1 to 2 mm away from the at least one inlet orifice along a primary flow axis of the lumen.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to forming the 3D rod array spaced 1 to 2 mm away from the at least one inlet orifice along a primary flow axis of the lumen in the modified device of Liu because Applicant has not disclosed that the 3D rod array being spaced 1 to 2 mm away from the at least one inlet orifice along a primary flow axis of the lumen provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, the instant specification provides the 3D rod array being spaced 1 to 2 mm away from the at least one inlet orifice along a primary flow axis of the lumen as exemplary (Pg. 3, ln 3-10). One of ordinary skill in the art, furthermore, would have expected the patient interface of the modified device of Liu, and Applicant’s patient interface, to perform equally well because both mechanisms perform the same function of delivering the dry powder to the infant.
Therefore, it would have been prima facie obvious to modify the modified device of Liu to obtain the invention as specified in claims 22-23 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired delivery of the dry powder to the infant and thus fails to patentably distinguish over the modified device of Liu
Claim(s) 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Baker as applied to claim 1 above, and further in view of Mattson (U.S. Pat. No. 280,202).
Regarding Claim 13, the modified device of Liu discloses the air jet DPI system, shown above.
The modified device of Liu does not specifically disclose the air jet DPI system wherein the patient interface comprises a nasopharyngeal tube.
Mattson teaches a medical powder injector (Fig. 1-2) comprising a nasopharyngeal tube (O; Fig. 3) as a patient interface (Pg. 1, ln 55-71) for the purpose of rendering the patient interface more convenient (Pg. 1, ln 55-71).
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 Liu to include the patient interface comprises the nasopharyngeal tube as taught by Mattson for the purpose of rendering the patient interface more convenient (See Mattson: Pg. 1, ln 55-71).
Regarding Claim 14, the modified device of Liu discloses the air jet DPI system, shown above.
The modified device of Liu does not specifically disclose the air jet DPI system further comprising a bend in flow path downstream of the air jet DPI of 10° to 45°.
Mattson teaches a medical powder injector (Fig. 1-2) comprising nasopharyngeal tube (O; Fig. 3) as a patient interface (Pg. 1, ln 55-71) having a bend in flow path downstream of an air jet DPI (A; Fig. 1, 2) of 10° to 45° (Fig. 3) for the purpose of rendering the patient interface more convenient (Pg. 1, ln 55-71)
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 Liu to include the bend in flow path downstream of the air jet DPI of 10° to 45° as taught by Mattson for the purpose of rendering the patient interface more convenient (See Mattson: Pg. 1, ln 55-71).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Baker as applied to claim 1 above, and further in view of Ji et al. (CN 201346338 Y; hereinafter: “Ji”).
Regarding Claim 15, the modified device of Liu discloses the air jet DPI system further comprising a drying chamber (See Liu: 3; Fig. 2).
The modified device of Liu does not specifically disclose the air jet DPI system comprising a one-way valve configured for admitting air from the environment into the air jet DPI system when the gas source volume is expanding.
Ji teaches a DPI comprising a one-way valve (2’’’; Fig. 5; Pg. 5, ln 6; Pg. 7, ln 6-23) configured for admitting air from the environment into an air jet DPI system (1’’’, 8’’’; Fig. 5) when a gas source volume (9’’’; Fig. 5) is expanding (Pg. 7, ln 6-23) for the purpose of only allowing ambient air into the gas source and prevent air from being drawn in the wrong direction (Pg. 7, ln 6-23).
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 Liu to include the one-way valve configured for admitting air from the environment into the air jet DPI system when the gas source volume is expanding as taught by Ji for the purpose of only allowing ambient air into the gas source and prevent air from being drawn in the wrong direction (See Ji: Pg. 7, ln 6-23).
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Baker in view of Ji as applied to claim 15 above, and further in view of Virtanen (WO 9841261 A1).
Regarding Claim 12, the modified device of Liu discloses the air jet DPI system, shown above.
The modified device of Liu does not specifically disclose the air jet DPI system wherein the drying chamber houses a powder free desiccant.
Virtanen teaches an inhalation device comprising a drying chamber (14, 16; Fig. 1, 2; Abstract) the houses a powder free desiccant (“silica gel”; Pg. 1, ln 17-18) for the purpose of absorbing moisture (Pg. 1, ln 17-18).
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 Liu to include the drying chamber housing the powder free desiccant as taught by Virtanen for the purpose of absorbing moisture (See Virtanen: Pg. 1, ln 17-18).
Allowable Subject Matter
Claim 10-11 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 24-28, 35-38, and 41-42 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Prior art, shown above, alone or in combination fail to disclose or render obvious the subject matter of claim 10, 24, 25, 35-38, and 41-42 .
Conclusion
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785