DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
The Amendment filed 5/21/2026 has been entered. Claims 1, 5, 7-8, 10, and 12-13 were amended. Thus, claims 1-15 are pending in the application.
Information Disclosure Statement
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 references have been placed in the application file, but the information referred to therein has not been considered.
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 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.
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.
Claims 1, 3, 6-11, and 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 for a 4.0 mg/ml pirfenidone solution is greater than 0.9 mg/min and the respirable delivered dose rate for a 19.0 mg/ml pirfenidone solution is greater than 4.3 mg/min to deliver a total respirable 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 for a 4.0 mg/ml pirfenidone solution is greater than 0.9 mg/min and the respirable delivered dose rate for a 19.0 mg/ml pirfenidone solution is greater than 4.3 mg/min to deliver a total respirable 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 respirable delivered dose rate for a 4.0 mg/ml pirfenidone solution is greater than 0.9 mg/min and the respirable delivered dose rate for a 19.0 mg/ml pirfenidone solution is greater than 4.3 mg/min (the aqueous solution of pirfenidone concentration can be from about 0.1-60 mg/mL; the effective dosage output rate is between 0.1-1 mL/min; at the upper end of 1 mL/min of an output rate, a 4.0 mg/mL solution would yield a delivered rate of 4.0 mg/min; at 1 mL/min, a 19.0 mg/mL solution would yield a delivered rate of 19.0 mg/min) (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 include delivering the respirable delivered dose rate for a 4.0 mg/ml pirfenidone solution at greater than 0.9 mg/min and the respirable delivered dose rate for a 19.0 mg/ml pirfenidone solution at greater than 4.3 mg/min for a total respirable 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 the total dose of the aqueous pirfenidone solution greater than 25 mg of pirfenidone (Surber, [0243], discloses a respirable delivered dose of pirfenidone of 25 mg or higher).
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), and a fine particle fraction (FPF) at least 45% (Surber, Table 12).
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 with an output 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, and establishes a vent pathway between ambient air and the head space of the reservoir).
Regarding claim 13, the modified method of Gallem has the vent pathway traversing the closure (Denyer, Figs. 7-9, central hole 26 traverses the lid 25).
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.
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 wherein the respirable delivered dose rate does not decrease during 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.
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 15, 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.
Claims 1 and 12 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) the solution as pirfenidone solution to treat a patient suffering from interstitial lung disease, wherein the respirable delivered dose rate for a 4.0 mg/ml pirfenidone solution is greater than 0.9 mg/min and the respirable delivered dose rate for a 19.0 mg/ml pirfenidone solution is greater than 4.3 mg/min to deliver a total respirable 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 for a 4.0 mg/ml pirfenidone solution is greater than 0.9 mg/min and the respirable delivered dose rate for a 19.0 mg/ml pirfenidone solution is greater than 4.3 mg/min to deliver a total respirable 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 respirable delivered dose rate for a 4.0 mg/ml pirfenidone solution is greater than 0.9 mg/min and the respirable delivered dose rate for a 19.0 mg/ml pirfenidone solution is greater than 4.3 mg/min (the aqueous solution of pirfenidone concentration can be from about 0.1-60 mg/mL; the effective dosage output rate is between 0.1-1 mL/min; at the upper end of 1 mL/min of an output rate, a 4.0 mg/mL solution would yield a delivered rate of 4.0 mg/min; at 1 mL/min, a 19.0 mg/mL solution would yield a delivered rate of 19.0 mg/min) (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 include delivering the respirable delivered dose rate for a 4.0 mg/ml pirfenidone solution at greater than 0.9 mg/min and the respirable delivered dose rate for a 19.0 mg/ml pirfenidone solution at greater than 4.3 mg/min for a total respirable 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 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).
Response to Arguments
Applicant's arguments filed 5/21/2026 have been fully considered but they are not persuasive.
On page 7 in the “Specification Objections” and “Claim Objections” sections of the Applicant’s remarks, the Applicant argues that the specification and claims have been amended to overcome the objections of the previous office action. The Examiner agrees, and has thus withdrawn those objections.
On page 7 in the “Claim Rejections - 35 U.S.C. 112(b)” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the 35 U.S.C. 112(b) rejections of the previous office action. The Examiner agrees, and has thus withdrawn those 35 U.S.C. 112(b) rejections.
On pages 8-9 in the “A. The Claimed Method Using a Unique Nebulizer-Drug Combination, Exhibits Unexpected Results” section of the Applicant’s remarks, the Applicant argues that the synergy of a nebulizer having a vent pathway and delivering aqueous pirfenidone achieves a significant and unexpected increase in the respirable dose output rate compared to the nebulizer delivering a saline solution, where the vent pathway achieves a decrease in output rate with the saline solution, and thus exhibits unexpected results. However, the Examiner respectfully disagrees. According to the MPEP 716.02, allegations of unexpected results are meant to be from the differences between the Applicant’s invention and the closest prior art of record. As the Applicant has not provided any evidence comparing their invention with the closest prior art of record, the Applicant has not set forth sufficient evidence to support unexpected results. Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
On pages 9-10 in the “B. Gallen Teaches Neither a Vent Pathway Not the Use of a Pirfenidone Solution” section of the Applicant’s remarks, the Applicant argues that Gallem does not teach a vent pathway or a pirfenidone solution, nor the related reservoir pressure conditions and aerosolization performance including respirable dose output rate, and so cannot teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, the vent pathway is taught by Denyer or Hu and the pirfenidone solution and aerosolization performance is taught by Surber as detailed in the 35 U.S.C. 103 rejections of claim 1 detailed above. Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
On pages 9-10 in the “B. Gallen Teaches Neither a Vent Pathway Not the Use of a Pirfenidone Solution” section of the Applicant’s remarks, the Applicant argues that Gallem does not recognize the problem of pressure changes occurring in a sealed reservoir during nebulization, and so does not provide the motivation to modify its system to include a vent pathway. However, the Examiner respectfully disagrees. Gallem is not used to provide the motivation for including a vent pathway, as this is instead drawn from the teaching references of Denyer or Hu used to provide the modification. Denyer teaches a vent pathway allows the pressure in the reservoir to be maintained at ambient pressure, thereby allowing the liquid level within the reservoir to fall as liquid is atomized (Denyer; Fig. 7; paras. [0051-0052]), while Hu teaches a vent pathway would allow for recycling of aerosol that condenses in the mixing chamber as well as result in the reservoir being connected to ambient pressure (Hu; Fig. 5; para. [0039]). Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
On page 10 in the second paragraph of the Applicant’s remarks, the Applicant argues that the Denyer and Surber references fail to recognize the unexpected increase in dose output, and consequently the improved pharmacokinetics of the Applicant’s claimed nebulizer. However, the Examiner respectfully disagrees. Surber teaches the Applicant’s claimed dose output of respirable dose rates greater than 0.9 mg/min and greater than 4.3 mg/min to deliver at least 7 mg of pirfenidone, as Surber teaches the aqueous solution of pirfenidone concentration can be from about 0.1-60 mg/mL while the effective dosage output rate is between 0.1-1 mL/min. Therefore, at the upper end of 1 mL/min for the output rate, a 4.0 mg/mL solution would yield a delivered rate of 4.0 mg/min and a 19.0 mg/mL solution would yield a delivered rate of 19.0 mg/min, which are respectively greater than 0.9 mg/min and 4.3 mg/min (Surber [0015]-[0016]). Surber also teaches a final respirable dose of at least 7 mg of pirfenidone (Surber para. [0016] discloses a pirfenidone dose of 0.1-360 mg). Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
On page 10 in the third and fourth paragraphs of the Applicant’s remarks, the Applicant argues that Denyer does not teach maintaining the reservoir at ambient pressure as a functional objective but rather ensuring fluid continuity for the reservoir, and so cannot teach the Applicant’s claimed invention as it is directed to a fundamentally different problem. However, the Examiner respectfully disagrees. According to the MPEP 2144(IV), “The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant”. Therefore, even though the Denyer reference may teach a vent pathway for a different reason or to solve a different problem than the Applicant, the Denyer reference can still be used to teach the vent pathway as claimed. Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
On page 10 in the fifth paragraph of the Applicant’s remarks, the Applicant argues that the combination of Denyer and Surber lacks a recitation of an aqueous solution of pirfenidone. However, the Examiner respectfully disagrees. Surber does teach an aqueous solution of pirfenidone (Surber para. [0015] recites, “the liquid nebulizer is characterized as having… the pirfenidone or pyridone analog compound administered to the mammal… emitted droplet size distribution of the aqueous solution…”). Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
On page 10 in the fifth paragraph of the Applicant’s remarks, the Applicant argues that the Surber reference is silent with regards to the unexpected, synergistic benefit of using a nebulizer with a vent pathway to deliver pirfenidone, and so cannot be used to teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Gallem teaches the nebulizer structures as claimed save for the vent pathway taught by Denyer and the use of pirfenidone solution with related dosing parameters taught by Surber, and so this combination of prior art teaches the whole of the Applicant’s claim 1 invention. Moreover, as previously explained above, the Applicant has not provided evidence to prove there are unexpected results of using their claimed invention compared to the current prior art of record. Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
On page 10 in the last paragraph to page 11 in the first paragraph of the Applicant’s remarks, the Applicant argues that the combination of prior art is grounded in impermissible hindsight reconstruction. However, the Examiner respectfully disagrees. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
On page 11 in the “D. A Nexus Exists Between the Claimed Invention and the Evidence” section of the Applicant’s remarks, the Applicant argues that there is a clear nexus between the claimed subject matter and the demonstrated improvements attributable to unexpected results. However, the Examiner respectfully disagrees. As previously explained, the Applicant has not yet provided proof for their claimed invention having unexpected results in comparison to the prior art of record. As unexpected results have not yet been proven, an argument for a nexus of claimed limitations linked to unexpected results is moot. Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
On page 11 in the “E. The Evidence Overcomes Any Alleged Motivation to Combine” section of the Applicant’s remarks, the Applicant argues that their claimed invention provides unexpected and synergistic results for respirable dose output and enhanced pharmacokinetic parameters not predicted by the teaching references, and so the current prior art of record cannot be used to teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. Firstly, Surber does teach the claimed respirable dose output and enhanced pharmacokinetic parameters, as Surber teaches the Applicant’s claimed dose outputs of respirable dose rates greater than 0.9 mg/min and greater than 4.3 mg/min with respective 4.0 mg/mL and 19.0 mg/mL concentrations of aqueous pirfenidone to deliver at least 7 mg of pirfenidone (Surber paras. [0015-0016]). Secondly, the Applicant has not provided evidence to prove there are unexpected results of using their claimed invention compared to the current prior art of record. Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
On page 12 in the “Claims 2, 4, 5, 14, and 15” section of the Applicant’s remarks, the Applicant argues that the current prior art of record cannot teach the dependent claims of Applicant’s claimed invention for the reasons set forth in Sections A-E above, such as the Applicant’s invention exhibiting unexpected results and the prior art failing to recognize the claimed performance advantages. However, the Examiner respectfully disagrees as previously explained in the above responses to the arguments in Sections A-E. Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
On page 13 in the first paragraph of the Applicant’s remarks, the Applicant argues that Hu does not teach a vent pathway configured to maintain ambient pressure in the medicine cup reservoir headspace as Hu has a closed-loop fluid recirculation architecture of a fundamentally different objective different from the Applicant’s maintaining the headspace at a continuous ambient pressure throughout nebulization. However, the Examiner respectfully disagrees. Hu teaches a first opening 134 which is open to the ambient environment via the dispensing tube 132, wherein the first opening 134 fluidly communicates with a second opening 135 to the reception space 10 of liquid medicine, thereby allowing the ambient environment to fluidly communicate with the reception space 10 above the liquid medicine, i.e. reservoir headspace, during use (Hu; Fig. 5; para. [0039]). Also, please recall that the MPEP 2144(IV) recites, “The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant”. Therefore, even though the Hu reference may teach a vent pathway configured to maintain ambient pressure in the medicine cup reservoir headspace for a different reason or to solve a different problem than the Applicant, the Hu reference can still be used to teach the vent pathway as claimed. Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
On page 13 in the second paragraph of the Applicant’s remarks, the Applicant argues that the combination of Gallem, Hu, and Surber cannot reasonably suggest or predict the claimed performance advantages involving the unexpected synergetic benefit of the nebulizer with a vent pathway to maintain ambient pressure and its use to deliver a pirfenidone solution as claimed. However, the Examiner respectfully disagrees. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Gallem teaches the nebulizer structures as claimed save for the vent pathway taught by Hu and the use of pirfenidone solution with related dosing parameters taught by Surber, and so this combination of prior art teaches the whole of the Applicant’s claim 1 invention. Moreover, as previously explained above, the Applicant has not provided evidence to prove there are unexpected results of using their claimed invention compared to the current prior art of record. Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
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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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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