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 .
Election/Restrictions
Applicant’s election with traverse of Group II, drawn to a metered dose inhaler, which embraces claims 2-21 as amended, in the reply filed 5/7/2026 is acknowledged.
The traversal is on the ground(s) that the amounts of active pharmaceutical ingredient taught in the prior art is much broader than the instantly claimed range. This is not found persuasive. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Applicant also contends that the prior art references do not teach or suggest the object of the present invention, which is to provide a MDI comprising an anticholinergic agent having a low global warming potential and improved physical and chemical stability. This is not found persuasive. 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. MPEP 2144.
In light of the amendment, claims 2-21 have been examined.
This requirement is still deemed proper and therefore is made FINAL.
Specification
The disclosure is objected to because of the following informalities:
Reference 8 of Figure 2 lacks a corresponding label/explanation in the specification.
Appropriate correction is required.
The use of terms such as BESPAK and APTAR, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2-17 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Knopeck et al. (US 2016/0324778 A1, published 11/10/2016, cited on the 7/25/2024 IDS), as evidenced by Lulla et al. (US2013/0295023 A1, published 11/7/2013).
(Note: Rejections are ordered based on dependencies.)
Regarding claim 6, Knopeck teaches a metered dose inhaler [Figure 1] comprising a metering valve [0056; 0063], canister [0056; 0063], and actuator [0056; 0063] including a nozzle block [0056; 0063]. The canister of the inhaler contains a medicament formulation [0056; claim 20] comprising propellant and at least one medically active compound [claim 20]. Knopeck teaches that the propellant may comprise of HFO-1234ze(E) (i.e. trans-1,3,3,3-tetrafluoropropene) [0015]. Knopeck further teaches that the medically active compound may comprise of ipratropium bromide [0027; claim 7].
Regarding claim 14, Knopeck teaches that the propellant may comprise about 60% to about 99% propellant by weight of the composition [0021]. It would be obvious to use HFO-1234ze(E), a propellant taught by Knopeck, in the amount that propellants are taught to be suitable in. Where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. MPEP 2144.05.
Regarding claim 16, Knopeck teaches a metered dose inhaler [Figure 1] comprising a metering valve [0056; 0063], canister [0056; 0063], and actuator [0056; 0063] including a nozzle block [0056; 0063]. The canister of the inhaler contains a medicament formulation [0056; claim 20] comprising propellant and at least one medically active compound [claim 20]. Knopeck teaches that the propellant may comprise of HFO-1234ze(E) (i.e. trans-1,3,3,3-tetrafluoropropene) [0015]. Knopeck further teaches that the medically active compound may comprise of ipratropium bromide [0027; claim 7]. Knopeck also teaches that the medicament formulation may contain other ingredients, including stabilizing agents such as citric acid [0051], and cosolvents such as water and ethyl alcohol (i.e. ethanol) [0047].
Regarding claim 17, Knopeck teaches a metered dose inhaler [Figure 1] comprising a metering valve [0056; 0063], canister [0056; 0063], and actuator [0056; 0063] including a nozzle block [0056; 0063]. The canister of the inhaler contains a medicament formulation [0056; claim 20] comprising propellant and at least one medically active compound [claim 20]. The medically active compound may be part of a solution [0023]. Knopeck teaches that the propellant may comprise of HFO-1234ze(E) (i.e. trans-1,3,3,3-tetrafluoropropene) ([0015]. The propellant may be present in the amount of about 5% to 99% by weight of the composition [0042], or preferably, about 60% to about 99% propellant by weight of the composition [0021]. Knopeck further teaches that the medically active compound may comprise of an anticholinergic agent such as ipratropium bromide [0027; claim 7]. The amount of the medicinal compound may comprise from about 0.01% to about 0.5% by weight of the composition [0021]. Where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. MPEP 2144.05.
Regarding claims 2-5 and 21, Knopeck teaches that the medicinally active compound may comprise of an anticholinergic agent, such as tiotropium (reads on long-acting muscarinic antagonist of claim 2) and ipratropium bromide [0027]. As evidenced by Lulla, ipratropium bromide is a quaternary ammonium salt (reads on claim 4) [0015].
Regarding claim 7, this claim recites the limitation wherein the active pharmaceutical ingredient “consists essentially of ipratropium bromide”. The transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976). Absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising.” MPEP 2111.03. Knopeck teaches that the medicament formulation may comprise of one or more medically active compounds, which may comprise of ipratropium bromide [0027; claim 7].
Regarding claims 8 and 11, Knopeck teaches that the medicament formulation may comprise of cosolvents such as ethyl alcohol (i.e. ethanol) and water [0047].
Regarding claim 9, Knopeck teaches that the cosolvent may be present in the composition in a propellant:cosolvent weight ratio of from about 50:50 to about 99:1 [0048]. Thus, the cosolvent may be present in the range of an amount about equal to the amount of propellant (i.e. 100% the amount of propellant), to an amount equal to about 0.0101% the amount of propellant. As discussed, Kopeck teaches that the propellant may comprise about 60% to about 99% propellant by weight of the composition [0021], and further teaches that ethanol is a suitable cosolvent for inclusion in the composition. Thus, the instant claimed range of ethanol overlaps with the range taught in the prior art and is prima facie obvious. MPEP 2144.05. (For example, if the composition is 80% propellant by weight, and ethanol is present at 10% by weight of the composition, this equates to ethanol being present in the composition in an amount equal to 12.5%, which falls within the disclosed range of 0.0101% to 100%.)
Regarding claim 10, Knopeck also teaches that the medicament formulation may further comprise of a stabilizing agent such as citric acid [0051].
Regarding claim 12, Knopeck teaches that the stabilizing agent, such as citric acid, may be present in the amount of about 40 to about 100 ppm by weight of the composition (i.e. 0.004% to 0.01%) [0051]. It would be obvious to use citric acid, a stabilizing agent, in the amount that stabilizing agents are taught to be suitable in. Thus, the instant claimed range of ethanol overlaps with the range taught in the prior art and is prima facie obvious. MPEP 2144.05.
Regarding claim 13, Knopeck teaches that the cosolvent may be present in the composition in a propellant:cosolvent weight ratio of from about 50:50 to about 99:1 [0048]. Thus, the cosolvent may be present in a range from an amount about equal to the amount of propellant (i.e. 100% the amount of propellant), to an amount equal to about 0.0101% the amount of propellant. As discussed, Kopeck teaches that the propellant may comprise about 60% to about 99% propellant by weight of the composition [0021], and further teaches that water is a suitable cosolvent for inclusion in the composition. Thus, the instant claimed range of water overlaps with the range taught in the prior art and is prima facie obvious. MPEP 2144.05. (For example, if the composition if 99% propellant and 1% water, as instantly claimed, this falls within the disclosed ratio taught by the prior art.)
Regarding claim 15, Knopeck teaches that the medicinal compound may comprise from about 0.01% to about 0.5% by weight of the composition [0021]. This overlaps with the instant claimed range and is prima facie obvious. MPEP 2144.05.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Knopeck et al. (US 2016/0324778 A1, published 11/10/2016, cited on the 7/25/2024 IDS) as applied to claim 17 above, and further in view of Brambilla (US 2009/0020114 A1, published 1/22/2009).
Regarding claim 18, Knopeck teaches the metered dose inhaler of claim 17 (as previously discussed), but does not explicitly teach a metering valve comprising a metering chamber having a size between 25 microliters and 200 microliters. Brambilla teaches a metered dose inhaler for delivering medication [Abstract], comprising a metering valve [0006-0007, canister [0006-0007], and actuator comprising a nozzle [0006-0007]. Brambilla further teaches that the metering valve comprises a metering chamber with a size of 50 microliters to 100 microliters [0041]. It would be obvious to one of ordinary skill, before the effective filing date of the claimed invention, to modify the teachings of Knopeck with that of Brambilla, to include a metering valve comprising a metering chamber with the instantly claimed size, in order to deliver a desired, predetermined amount of the formulation per actuation [0088]. Where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. MPEP 2144.05. Additionally, absent evidence of criticality, it would have been obvious to try a metering valve chamber between 25 and 200 microliters for the purpose of providing a chamber sized to provide a desired dose. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 19, Knopeck teaches the metered dose inhaler of claim 17 (as previously discussed), but does not explicitly an actuator wherein the exit orifice diameter is between 0.12 mm and 0.4 mm. Brambilla teaches a metered dose inhaler for delivering medication [Abstract], comprising a metering valve [0006-0007, canister [0006-0007], and actuator comprising a nozzle [0006-0007]. Brambilla further teaches that convention metered dose inhaler actuators have nozzle channel (reads on exit orifice, see para. 0058) with variable diameters in the range of 0.25 to 0.45 mm [0059]. The invention of Brambilla has a nozzle channel diameter of 0.15 mm to 0.4 mm [0076]. This overlaps with the instant claimed range of exit orifice diameters and is prima facie obvious. MPEP 2144.05. Furthermore, Brambilla teaches that the different drugs have different flow and dispersion characteristics, and adjusting the nozzle/exit orifice diameter to a particular drug and propellant formulation is necessary to achieve an optimum balance between plume (i.e. spray) shape, dose volume and plume duration [0008]. Thus, absent evidence of criticality, it would have been obvious to try an exit orifice diameter between 0.12 mm and 0.4 mm in the course of routine optimization. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Knopeck et al. (US 2016/0324778 A1, published 11/10/2016, cited on the 7/25/2024 IDS) as applied to claim 17 above, and further in view of Corr et al. (US 2020/0016120 A1, published 1/16/2020, cited on the 7/25/2024 IDS).
Regarding claim 20, Knopeck does not explicitly teach a canister wherein the cannister comprises from about 1 mL to about 30 mL of the composition. Corr teaches a metered dose inhaler wherein the canister contains a composition comprising a propellant and a drug component [Abstract; 0013-0016]. Corr further teaches a canister wherein the volume is 14 mL [0136]. Corr discloses that the canister may be filled with enough of the pharmaceutical composition to provide for a plurality of doses, and that MDIs typically contain from 50 to 150 individual doses [0130]. Thus, Corr teaches an embodiment wherein the canister may comprise up to 14 mL of the pharmaceutical composition. This overlaps with the instant claimed range and is prima facie obvious. MPEP 2144.05. It would be obvious to one of ordinary skill to modify the teachings of Knopeck with that of Corr to construct an inhaler using a canister with a volume of 14 mL, and accordingly fill it with an amount of pharmaceutical composition falling within the instantly claimed range, in order to create an inhaler that delivers a desired number of doses. Absent evidence of criticality, it would have been obvious to try a cannister comprising from about 1 mL to about 30 mL of the composition in the course of routine optimization. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA LYNN CHI whose telephone number is (571)272-0026. The examiner can normally be reached Monday - Friday 9 am-5pm ET.
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/AMANDA LYNN CHI/Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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