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 Amendment
This Office Action is in response to a preliminary amendment filed on 3/6/2024. As directed by the preliminary amendment, claims 10-11 were canceled, claims 2, 5-6, 9, 13-14, 16, and 18-20 were amended, and claims 21-22 were added. Thus, claims 1-9, and 12-22 are pending for this application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9, 12 and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 9, 12 and 22 contain the phrase “pharmaceutically acceptable salt or ester thereof”. This phrase unclear because what is considered pharmaceutically acceptable changes over time, and thus the metes and bounds of the claimed invention are not clear.
The remaining claims are rejected due to dependence on a rejected base claim.
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.
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.
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) 1-9, 12-13, 16-22 are rejected under 35 U.S.C. 103 as being unpatentable over Knopeck (US 2016/0324778) in view of Joshi (US 2023/0026203).
Regarding claim 1, Knopeck discloses (Fig. 1) a metered dose inhaler comprising:
a metering valve (metered dose dispensing valve 4, paragraphs [0056] and [0063] and Fig. 1);
a canister (aerosol canister 2); and
an actuator (actuator 8) comprising an actuator nozzle (nozzle block 16 with orifice 18);
wherein the canister comprises a formulation, the formulation comprising greater than 70% by weight of propellant HFO-1234ze (5% to 95% HFO-1234ze by weight, paragraph [0042]), and
at least one active pharmaceutical ingredient (paragraph [0027]) dissolved (paragraph [0023]) in the formulation to form a solution (paragraphs [0023] and [0027]).
While Knopeck discloses a propellant in the form of HFO-1234ze, Knopeck does not disclose the propellant is specifically HFO-1234ze(E).
However, Joshi teaches (Fig. 1) and MDI having a propellant in the form of HFO-1234ze(E) (paragraph [0128]).
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 propellant of Knopeck to be in the form of HFO-1234ze(E), as taught by Joshi, for the purpose of providing a pharmaceutical grade form of HFO-1234ze that is in compliance with GMP regulations for use in humans and consistent with major health authorities guidelines (paragraph [0128] Joshi).
Regarding claim 2, modified Knopeck discloses wherein the active pharmaceutical ingredient is selected from beta agonists, corticosteroids, anticholinergic agents, TYK inhibitors, and combinations thereof (paragraph [0027] Knopeck).
Regarding claim 3, modified Knopeck discloses wherein the corticosteroid is selected from beclomethasone and ciclesonide (beclomethasone, paragraph [0027] Knopeck).
Regarding claim 4, modified Knopeck discloses wherein the anticholinergic agent is selected from ipratropium, tiotropium, aclidinium, umeclidinium, and glycopyrronium (ipratropium, paragraph [0027]).
Regarding claim 5, modified Knopeck discloses wherein the beta agonist is selected from formoterol, indacaterol, olodaterol, vilanterol, and abediterol (formoterol, paragraph [0027]).
Regarding claim 6, modified Knopeck discloses wherein the formulation comprises at least two active pharmaceutical ingredients in solution (paragraphs [0026]-[0027] Knopeck).
Regarding claim 7, modified Knopeck discloses wherein one active pharmaceutical ingredient is a short- or long-acting beta agonist and one active pharmaceutical ingredient is a corticosteroid in solution (paragraphs [0026]-[0027] Knopeck).
Regarding claim 8, modified Knopeck discloses wherein the formulation further comprises an anticholinergic agent in solution (paragraphs [0026]-[0027] Knopeck).
Regarding claim 9, Knopeck discloses (Fig. 1) a metered dose inhaler comprising:
a metering valve (metered dose dispensing valve 4, paragraphs [0056] and [0063] and Fig. 1);
a canister (aerosol canister 2); and
an actuator (actuator 8) comprising an actuator nozzle (nozzle block 16 with orifice 18);
wherein the canister comprises a formulation, the formulation comprising greater than 70% by weight of propellant HFO-1234ze (5% to 95% HFO-1234ze by weight, paragraph [0042]), and
at least one active pharmaceutical ingredient (paragraph [0027]) dissolved (paragraph [0023]) in the formulation to form a solution (paragraphs [0023] and [0027]), the active pharmaceutical ingredient comprising;
beclomethasone (paragraph [0027]) or a pharmaceutically acceptable salt or ester thereof, wherein the beclomethasone or pharmaceutically acceptable salt or ester thereof is dissolved in the formulation to form a solution (paragraph [0027]); and/or
formoterol (paragraph [0027]) or a pharmaceutically acceptable salt or ester thereof, wherein the formoterol or pharmaceutically acceptable salt or ester thereof is dissolved in the formulation to form a solution (paragraph [0027]).
While Knopeck discloses a propellant in the form of HFO-1234ze, Knopeck does not disclose the propellant is specifically HFO-1234ze(E).
However, Joshi teaches (Fig. 1) and MDI having a propellant in the form of HFO-1234ze(E) (paragraph [0128]).
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 propellant of Knopeck to be in the form of HFO-1234ze(E), as taught by Joshi, for the purpose of providing a pharmaceutical grade form of HFO-1234ze that is in compliance with GMP regulations for use in humans and consistent with major health authorities guidelines (paragraph [0128] Joshi).
Regarding claim 12, Knopeck discloses (Fig. 1) a metered dose inhaler comprising:
a metering valve (metered dose dispensing valve 4, paragraphs [0056] and [0063] and Fig. 1);
a canister (aerosol canister 2); and
an actuator (actuator 8) comprising an actuator nozzle (nozzle block 16 with orifice 18);
wherein the canister comprises a formulation, the formulation comprising greater than 70% by weight of propellant HFO-1234ze (5% to 95% HFO-1234ze by weight, paragraph [0042]), and
at least one active pharmaceutical ingredient (paragraph [0027]) dissolved (paragraph [0023]) in the formulation to form a solution (paragraphs [0023] and [0027]), the active pharmaceutical ingredient comprising
tiotropium (paragraph [0027]) or a pharmaceutically acceptable salt or ester thereof, wherein the tiotropium or pharmaceutically acceptable salt or ester thereof is dissolved in the formulation to form a solution (paragraph [0027]).
While Knopeck discloses a propellant in the form of HFO-1234ze, Knopeck does not disclose the propellant is specifically HFO-1234ze(E).
However, Joshi teaches (Fig. 1) and MDI having a propellant in the form of HFO-1234ze(E) (paragraph [0128]).
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 propellant of Knopeck to be in the form of HFO-1234ze(E), as taught by Joshi, for the purpose of providing a pharmaceutical grade form of HFO-1234ze that is in compliance with GMP regulations for use in humans and consistent with major health authorities guidelines (paragraph [0128] Joshi).
Regarding claim 13, modified Knopeck discloses wherein HFO- 1234ze(E) is the sole propellant (Knopeck discloses at least one HFO is used as thus it is contemplated that HFO-1234ze(E) is the sole propellant, see paragraph [0030] Knopeck).
Regarding claim 16, modified Knopeck discloses wherein the formulation further comprises an organic acid, an inorganic acid, or a combination thereof (paragraph [0051] Knopeck).
Regarding claim 17, modified Knopeck discloses wherein the formulation comprises 0.04% to 0.4% acid by weight of the total formulation (100 ppm, which is 0.01% concentration, paragraph [0051] Knopeck).
Regarding claim 18, modified Knopeck discloses the metering valve comprises a metering chamber (inside of valve 4 of Knopeck), but does not disclose the valve having a size between 25 microliters and 200 microliters. However, outside evidence of criticality, it would have been obvious to try to a valve chamber size between 25-200 microliters for the purpose of providing a chamber sufficiently sized for the dose to be inhaled by a user, since discovering the optimum value only involves routine skill in the art. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 19, modified Knopeck discloses the inhaler does not comprise coated internal components (device of Knopeck does not disclose the internal components are coated and discloses the claimed feature).
Regarding 20, modified Knopceck discloses the inhaler includes an actuator nozzle but does not disclose the actuator nozzle comprises an exit orifice effective diameter of 0.12 mm to 0.3 mm. However, outside evidence of criticality, it would have been obvious to try to an exit orifice effective diameter of the nozzle of about 0.12-0.3 mm for the purpose of providing a size sufficient to entrain the flow of particles and deliver the medicament to the user, since discovering the optimum value only involves routine skill in the art. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 21, modified Knopeck discloses the formulation comprises citric acid (paragraph [0051] Knopeck).
Regarding claim 22, modified Knopeck discloses wherein the amount of HFO-1234ze(E) by weight of the total propellant in the formulation is at least 90% (5% to 95% HFO-1234ze by weight, paragraph [0042]).
Claim(s) 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Knopeck (US 2016/0324778) in view of Joshi (US 2023/0026203), and further in view of Zeng (US 2012/0085345).
Regarding claim 14, modified Knopeck discloses a formulation, but does not disclose the formulation further comprises ethanol.
However, Zeng teaches (Fig. 1) an inhaler comprising a formulation including ethanol (paragraph [0027]).
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 formulation of modified Knopeck to include ethanol, as taught by Zeng, for the purpose of providing a co-solvent that is safe and effective for dissolving the active ingredient, thereby improving therapeutic outcome of patient (paragraph [0027] Zeng).
Regarding claim 15, modified Knopeck discloses wherein the amount of ethanol by weight of the total formulation is between 5% and 20% (6-15%, paragraph [0027] Zeng).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Power (US 2017/0189630) discloses an aerosol device having a formulation similar to applicant’s.
Brambilla (US 10,737,044) discloses an inhaler device with an effective diameter similar to applicant’s.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R MOON whose telephone number is (571)272-2554. The examiner can normally be reached Monday-Thursday 7:30am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW R MOON/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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