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 .
DETAILED ACTION
1. This office action is in response to the filing of the application on 2/21/2023. Since the initial filing, no claims have been amended, added, or canceled. Thus, claims 1-15 are pending in the application.
Information Disclosure Statement
2. The information disclosure statement filed 2/21/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. The following references have not been submitted:
WO 2012106382
WO 2015017728
WO 2015106150
These citations to reference have been placed in the application file, but the information referred to therein has not been considered.
Specification Objections
3. The disclosure is objected to because of the following informalities:
Paragraph [00159] is objected to for have a double period at the end of the sentence ending in “all of the periphery thereof..”
Appropriate correction is required.
Claim Interpretation- 35 USC § 112 – Sixth Paragraph/35 USC § 112(f)
4. 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.
At present, no limitations are interpreted under 35 USC 112(f).
Claim Objections
5. Claim 10 is objected to because of the following informalities:
Regarding claim 10, the phrase “the nebulizer has output rate” (ln. 1) should read --the nebulizer has an output rate--. Additionally, the phrase “in medicine cup reservoir” (ln. 2) should read -- in the medicine cup reservoir--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
6. 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.
7. Claims 1-15 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 pre-AIA the applicant regards as the invention.
Regarding claim 1, the phrase term “the range of concentrations of the pirfenidone solution” (ln. 16) is unclear for lacking an antecedent basis. For the purposes of examination, the limitation will be interpreted as the respirable dose rate for a concentration of pirfenidone solution. Additionally, the limitation “between greater than 0.9 mg/min…and greater than 4.3 mg/min” (ln. 17-18) is unclear how the concentration is both “greater” and “between” the concentration values. For the purposes of examination, the claim limitation with be interpreted as requiring a delivered dose range between 0.9-4.3 mg/min, and a pirfenidone solution concentration between 4.0-19 mg/ml for a total respirable dose of at least 7 mg of pirfenidone.
Regarding claim 7, the limitation “wherein a daily dose of the aqueous pirfenidone solution is greater than 25 mgs of pirfenidone” (ln. 1-2) is unclear if the limitation is further limiting to the method of claim 1 or is merely making a factual statement about aqueous pirfenidone solution. For the purposes of examination, the claim will be interpreted as the method comprising delivering a daily dose of the aqueous pirfenidone solution that is greater than 25 mgs of pirfenidone.
Regarding claim 8, the limitation “a fine particle fraction (FPF=% of aerosol particles ≤5 μm) of droplets emitted from the liquid nebulizer of at least about 45% greater than about 7 mg” (ln. 4-6)” is unclear because it appears the “greater than about 7 mg” portion of the limitation is unrelated to the FPF and instead is referring to an overall delivered dose amount. For the purposes of examination, the term “greater than about 7 mg” will be interpreted as the method delivering an overall dose amount that is greater than about 7 mg.
Regarding claim 13, the term “the enclosure” (ln. 1-2) lacks an antecedent basis. For the purposes of examination, the term will be interpretated as referring to “the housing” introduced in claim 1 (ln. 5-6).
Any remaining claims are rejected as being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 103
8. 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 of this title, 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.
9. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
10. Claims 1, 3, 6-13 are rejected under 35 U.S.C. 103 as being unpatentable over Gallem et al (2008/0006264) in view of Denyer et al (2003/0146300) and Surber (2012/0192861).
Regarding claim 1, Gallem discloses a method to deliver an aerosol to treat a patient (Fig. 4A depicts a nebulizer for performing a method to deliver an aerosol to a patient. See annotated Fig. 4A below):
(1) introducing an aqueous solution in a medicine reservoir cup of a nebulizer (Fig. 4A, liquid reservoir 102 is a medicine reservoir cup holding an aqueous solution);
(2) closing the medicine cup reservoir by attaching a closure to an opening in a housing of the nebulizer through which the aqueous solution was introduced to create a headspace within the medicine cup reservoir above the aqueous solution (Annotated Fig. 4A labels a “closure” that attaches to an opening in the housing of the nebulizer 100. This closure creates a head space above the aqueous solution);
(3) activating an aerosol generator having a vibrating mesh membrane to generate an aerosol formed from the aqueous solution in an aerosol mixing chamber (Fig. 4A, aerosol generator 4 has a vibrating mesh membrane 3 that generates an aerosol in the aerosol mixing chamber 103), wherein activating the vibrating mesh nebulizer is coincident with inhalation of the aerosol through a mouthpiece opening in the aerosol mixing chamber by the patient (Fig. 4A, mouthpiece 104 has an opening upon which the patient would inhale during operation of the nebulizer 100); and
(4) delivering the aerosol to the patient by inhalation (Fig. 4A, the generated aerosol would be inhaled by the patient through mouthpiece 104).
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Gallem does not disclose: (1) that ambient pressure is maintained in the headspace of the medicine cup reservoir during activation of the aerosol generator by allowing air to enter the medicine cup reservoir through a vent pathway in the nebulizer; (2) that the solution is pirfenidone solution to treat a patient suffering from interstitial lung disease, wherein the respirable delivered dose rate is between 0.9-4.3 mg/min for a pirfenidone concentration between 4.0-19.0 mg/ml to result in a dose of at least 7 mg of pirfenidone, or (3) achieving a reduced decline in a baseline of forced vital capacity in the patient suffering from interstitial lung disease.
However, Denyer teaches a vented nebulizing metering chamber comprising a reservoir (Fig. 7, reservoir 21. See annotated Fig. 7 below) that includes a vented pathway connecting a head space of the reservoir to ambient pressure to maintain ambient pressure in the head space (Fig. 7, central hole 26 serves as a filling hole and also a vent hole; see [0051]). This vented pathway allows the liquid level within the metering chamber to fall as the liquid is atomized by allowing air to enter the fluid reservoir (see [0052]).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the closure of the reservoir of Gallem to have a vent pathway as taught by Denyer. Having a vented pathway allows the pressure of the headspace in the reservoir to be maintained at ambient pressure, thereby allowing the liquid level within the reservoir to fall as liquid is atomized.
The modified method of Gallem does not have (1) the solution as pirfenidone solution to treat a patient suffering from interstitial lung disease, wherein the respirable delivered dose rate is between 0.9-4.3 mg/min for a pirfenidone concentration between 4.0-19.0 mg/ml to result in a dose of at least 7 mg of pirfenidone, or (2) achieving a reduced decline in a baseline of forced vital capacity in the patient suffering from interstitial lung disease.
However, Surber teaches the use of pirfenidone formulation to treat fibrotic and inflammatory diseases of the lungs (See abstract). Surber teaches dispensing pirfenidone from a liquid nebulizer ([0015]), wherein the pirfenidone has a concentration between 15-50 mg/mL and at an effective dosage output rate between 0.1-1 mL/min, which is equivalent to 1.5-15 mg/mL if the low end of 15 mg/mL is chosen (See [0015]-[0016]). Additionally, Surber teaches a final respirable dose of at least 7 mg of pirfenidone ([0016] discloses a pirfenidone dose of 0.1-360 mg). Finally, Surber teaches that this treatment results in a reduced decline in a baseline of forced vital capacity in the patient suffering from interstitial lung disease ([0148], last sentence).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the modified method of Gallem to deliver a pirfenidone solution at a concentration between 4.0-19.0 mg/ml and at a dose rate between 0.9- 4.3 mg/min for a total dose of at least 7 mg of pirfenidone as taught by Surber. Surber teaches that delivery of such a rate and concentration is effective for treating fibrotic and inflammatory diseases of the lungs (Abstract).
Regarding claim 3, the modified method of Gallem has the step of delivering the pirfenidone aerosol comprised of converting between 0.5 and 10 mL of the aqueous pirfenidone solution to the pirfenidone aerosol (Surber, [0010], discloses between 0.5 - 6 mL of aqueous solution of pirfenidone).
Regarding claim 6, the modified method of Gallem does not explicitly disclose the respirable delivered dose rate increasing during the duration of inhalation by the patient.
However, increasing the delivered dose rate during the duration of inhalation by the patient is considered obvious to try. See MPEP 2143(I)(E). Surber teaches that there is a recognized problem of needing to treat fibrotic and inflammatory diseases and proposes the use of pirfenidone formulation (Abstract). Surber additionally suggests a number of different dose delivery rates of pirfenidone to be effective with such a treatment (see [0015]). During delivery of the pirfenidone solution, there are only a finite number of identified, predictable potential solutions when it comes to the rate at which the pirfenidone is delivered during the duration of inhalation by the patient - (1) The dose rate remains steady throughout inhalation; (2) The dose rate decreases during inhalation; or (3) The dose rate increases during inhalation. One of ordinary skill in the art would have pursued any one of these treatment procedures to determine which would result in the best outcome for treating the patient.
Regarding claim 7, the modified method of Gallem has a daily dose of the aqueous pirfenidone solution greater than 25 mg of pirfenidone (Surber, [0243], discloses a respirable delivered daily dose of pirfenidone of 25 mg).
Regarding claim 8, the modified method of Gallem has the respirable delivered dose of the pirfenidone aerosol having a volumetric mean diameter (VMD) between 2-5 microns (Surber, Table 12), a geometric standard deviation (GSD) of emitted droplet size distribution between 1.0-3.4 (Surber, Table 12), a fine particle fraction (FPF) at least 45% (Surber, Table 12), and a respirable dose greater than about 7 mg (Surber, [0016]).
Regarding claim 9, the modified method of Gallem has a dose delivery rate is between greater than 2.8 and 6.25 mg of pirfenidone per minute (Surber, [0015]-[0016]).
Regarding claim 10, the modified method of Gallem has a nebulizer rate of at least 0.5 mL/min (Table 12) which would result in converting the entire volume of solution to an aerosol in about 8 minutes (3.85 mL total at a rate of 0.5 mL/min), which is between 1-20 minutes.
Regarding claim 11, the modified method of Gallem has the step of closing the medicine cup reservoir establishing a vent pathway between ambient air and the head space of the medicine cup reservoir (Denyer, Figs. 7-9, central hole 26 traverses the lid 25, as establishes a vent pathway between ambient air and the head space of the reservoir).
11. Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Gallem et al in view of Denyer and Surber, as applied to claim 1 above, and further in view of Stangl (8,387,895).
Regarding claim 2, the modified method of Gallem has the nebulizer configured to generate an aerosol of the aqueous solution of pirfenidone in the aerosol mixing chamber (Surber, [0016], discloses a generated aerosol of 1-5 microns).
The modified method of Gallem does not state the internal volume of the aerosol mixing chamber.
However, Stangl teaches a nebulizer comprising a mixing chamber having a volume between 60 -120 mL (cc) ((Fig. 1, nebulizer 1 has a mixing chamber 3. The abstract discloses the volume of the mixing chamber 3). This specific size of the mixing chamber allows continuously generated aerosol to accumulate therein without losses even when a patient’s exhalation phase is longer than their inhalation phase (Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design the size of the mixing chamber of the modified method of Gallem to be between 60-120 mL (i.e. greater than 49 cc) as taught by Stangl. Such a mixing chamber size allows continuously generated aerosol to accumulate within the mixing chamber without losses even when a patient’s exhalation phase is longer than their inhalation phase.
12. Claims 4-5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Gallem et al in view of Denyer and Surber, as applied to claim 1 above, and further in view of Babaev (6,601,581).
Regarding claim 4, the modified method of Gallem has the aerosol generator activating the vibrating mesh membrane for a duration to convert between 0.5-10 mL of the pirfenidone solution to the pirfenidone aerosol (Surber, [0010], discloses between 0.5 to 6 mL of pirfenidone solution).
The modified method of Gallem does not have a patient operated control circuit to activate the aerosol generator.
However, Babaev teaches a nebulizer (Fig. 2) comprising a liquid reservoir (Fig. 2, reservoir 19) and a vibrating aerosol generator (Fig. 2, piezo disk 15), wherein the aerosol generator is under patient operated control (Fig. 2, on/off button 21 activates the piezo disk 15 when pushed by the user).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design the nebulizer of the modified method of Gallem to have an on/off control button as taught by Babaev to allow the user to have full control over operation of the nebulizer.
Regarding claim 5, the modified method of Gallem has the aerosol generator activating the vibrating mesh membrane for a time interval determined by the volume of aqueous pirfenidone solution in the medicine reservoir cup (Surber, [0010], discloses aerosolizing between 0.5 to 6 mL of pirfenidone solution).
The modified method of Gallem does not have a patient operating a control circuit to activate the vibrating mesh generator.
However, Babaev teaches a nebulizer (Fig. 2) comprising a liquid reservoir (Fig. 2, reservoir 19) and a vibrating aerosol generator (Fig. 2, piezo disk 15), wherein the aerosol generator is under patient operated control (Fig. 2, on/off button 21 activates the piezo disk 15 when pushed by the user).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design the nebulizer of the modified method of Gallem to have an on/off control button as taught by Babaev to allow the user to have full control over operation of the nebulizer.
The modified method of Gallem does not explicitly disclose that the respirable delivered dose rate does not decrease during the duration of the inhalation by the patient.
However, not decreasing the delivered dose rate during the duration of inhalation by the patient is considered obvious to try. See MPEP 2143(I)(E). Surber teaches that there is a recognized problem of needing to treat fibrotic and inflammatory diseases and proposes the use of pirfenidone formulation (Abstract). Surber additionally suggests a number of different dose delivery rates of pirfenidone to be effective with such a treatment (see [0015]). During delivery of the pirfenidone solution, there are only a finite number of identified, predictable potential solutions when it comes to the rate at which the pirfenidone is delivered during the duration of inhalation by the patient - (1) The dose rate remains steady throughout inhalation; (2) The dose rate decreases during inhalation; or (3) The dose rate increases during inhalation. One of ordinary skill in the art would have pursued any one of these treatment procedures to determine which would result in the best outcome for treating the patient.
Regarding claim 14, the modified method of Gallem has the patient inhaling the pirfenidone aerosol through a mouthpiece affixed to an end of the aerosol mixing chamber (Gallem, Fig. 4A, mouthpiece 104 would allow a user to inhale the pirfenidone aerosol).
The modified method of Gallem does not have the patient activating a control circuit.
However, Babaev teaches a nebulizer (Fig. 2) comprising a liquid reservoir (Fig. 2, reservoir 19) and a vibrating aerosol generator (Fig. 2, piezo disk 15), wherein the aerosol generator is under patient operated control (Fig. 2, on/off button 21 activates the piezo disk 15 when pushed by the user).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design the nebulizer of the modified method of Gallem to have an on/off control button as taught by Babaev to allow the user to have full control over operation of the nebulizer.
13. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gallem et al in view of Denyer and Surber, as applied to claim 1 above, and further in view of Borgschulte et al (2008/0308096).
Regarding claim 9, the modified method of Gallem does not have the delivery step further comprising the intake of ambient air through a one-way inspiratory valve in the aerosol mixing chamber during inhalation by the patient.
However, Borgschulte teaches a nebulizer comprising an aerosol mixing chamber (see Annotated Fig. 9 below), wherein the aerosol mixing chamber has a one-way inspiratory valve (Fig. 9, inspiratory valves 9a and 9b).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design the mixing chamber of the modified method of Gallem to have a one-way inspiratory valve as taught by Borgschulte to allow air to be drawn into the chamber to assist in the mixing of the generated aerosol.
14. Claims 1 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Gallem et al (2008/0006264) in view of Hu (2014/0216443) and Surber (2012/0192861).
Regarding claim 1, Gallem discloses a method to deliver an aerosol to treat a patient (Fig. 4A depicts a nebulizer for performing a method to deliver an aerosol to a patient. See annotated Fig. 4A below):
(1) introducing an aqueous solution in a medicine reservoir cup of a nebulizer (Fig. 4A, liquid reservoir 102 is a medicine reservoir cup holding an aqueous solution);
(2) closing the medicine cup reservoir by attaching a closure to an opening in a housing of the nebulizer through which the aqueous solution was introduced to create a headspace within the medicine cup reservoir above the aqueous solution (Annotated Fig. 4A labels a “closure” that attaches to an opening in the housing of the nebulizer 100. This closure creates a head space above the aqueous solution);
(3) activating an aerosol generator having a vibrating mesh membrane to generate an aerosol formed from the aqueous solution in an aerosol mixing chamber (Fig. 4A, aerosol generator 4 has a vibrating mesh membrane 3 that generates an aerosol in the aerosol mixing chamber 103), wherein activating the vibrating mesh nebulizer is coincident with inhalation of the aerosol through a mouthpiece opening in the aerosol mixing chamber by the patient (Fig. 4A, mouthpiece 104 has an opening upon which the patient would inhale during operation of the nebulizer 100); and
(4) delivering the aerosol to the patient by inhalation (Fig. 4A, the generated aerosol would be inhaled by the patient through mouthpiece 104).
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Gallem does not disclose: (1) that ambient pressure is maintained in the headspace of the medicine cup reservoir during activation of the aerosol generator by allowing air to enter the medicine cup reservoir through a vent pathway in the nebulizer; (2) that the solution is pirfenidone solution to treat a patient suffering from interstitial lung disease, wherein the respirable delivered dose rate is between 0.9-4.3 mg/min for a pirfenidone concentration between 4.0-19.0 mg/ml to result in a dose of at least 7 mg of pirfenidone, or (3) achieving a reduced decline in a baseline of forced vital capacity in the patient suffering from interstitial lung disease.
However, Hu teaches nebulizer (Fig. 5) comprising a liquid reservoir (Fig. 5, liquid container 1), wherein the liquid container is vented (Fig. 5, fluid recycle system 13 allows aerosolized spray to be recycled via a first opening 134 and a second opening 135 that connect the liquid reservoir to the mixing chamber and ambient air via mouthpiece 132).
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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 housing of the modified combination of Gallem to have two openings and a channel that connect the mixing chamber to the reservoir as taught by Hu. This connection would allow for recycling of aerosol that condenses in the mixing chamber as well as result in the reservoir being connected to ambient pressure such that ambient pressure is maintained in the headspace of the medicine cup reservoir during activation of the aerosol generator.
The modified method of Gallem does not have (1) the solution as pirfenidone solution to treat a patient suffering from interstitial lung disease, wherein the respirable delivered dose rate is between 0.9-4.3 mg/min for a pirfenidone concentration between 4.0-19.0 mg/ml to result in a dose of at least 7 mg of pirfenidone, or (2) achieving a reduced decline in a baseline of forced vital capacity in the patient suffering from interstitial lung disease.
However, Surber teaches the use of pirfenidone formulation to treat fibrotic and inflammatory diseases of the lungs (See abstract). Surber teaches dispensing pirfenidone from a liquid nebulizer ([0015]), wherein the pirfenidone has a concentration between 15-50 mg/mL and at an effective dosage output rate between 0.1-1 mL/min, which is equivalent to 1.5-15 mg/mL if the low end of 15 mg/mL is chosen (See [0015]-[0016]). Additionally, Surber teaches a final respirable dose of at least 7 mg of pirfenidone ([0016] discloses a pirfenidone dose of 0.1-360 mg). Finally, Surber teaches that this treatment results in a reduced decline in a baseline of forced vital capacity in the patient suffering from interstitial lung disease ([0148], last sentence).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the modified method of Gallem to deliver a pirfenidone solution at a concentration between 4.0-19.0 mg/ml and at a dose rate between 0.9- 4.3 mg/min for a total dose of at least 7 mg of pirfenidone as taught by Surber. Surber teaches that delivery of such a rate and concentration is effective for treating fibrotic and inflammatory diseases of the lungs (Abstract).
Regarding claim 12, the modified method of Gallem has the vent pathway traversing the housing in the housing of the nebulizer to connect the headspace of the medicine cup reservoir cup to ambient air (Hu, Fig. 5, first vent opening 134 and second vent opening 135 traverse the housing of the nebulizer to connect the head space of the reservoir to ambient air) and the closure seals the opening in the housing of the nebulizer through which the aqueous solution of pirfenidone was introduced (Gallem, Fig. 4A, depicts the closure as sealing the opening in the housing of the nebulizer).
Regarding claim 13, the modified method of Gallem has the vent pathway traversing the enclosure (i.e. housing) (Hu, Fig. 5, first vent opening 134 and second vent opening 135 traverse the housing of the nebulizer).
Conclusion
15. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Boehm (2007/0181133), Gallem (2006/0207591), Yu (2015/0231660), and Muller (2018/0169713) disclose method of delivering aqueous solutions in a medicine cup reservoir within liquid nebulizers, wherein the liquid nebulizers comprise aerosol generators having vibrating mesh membranes for atomizing the aqueous solutions.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY A STANIS whose telephone number is (571)272-5139. The examiner can normally be reached on Mon - Fri 8:30-5:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Justine Yu can be reached on 571-272-4835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY A STANIS/Primary Examiner, Art Unit 3785