DETAILED ACTION
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
Applicant's amendment filed 21 Aug 2025 has been entered. Claims 21-25, 27, 29-35, and 37-43 are pending in the application with claim 26 canceled. Claims 21, 32, 37, and 41-42 are currently amended with claim 43 newly added. Applicant’s amendment to the Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 21 May 2025.
Response to Arguments
Applicant's arguments, see Pg. 7-12, filed 21 Aug 2025, with respect to the 35 U.S.C. 112(a) rejection of claims 21, 32, 37, 41, and 42 have been fully considered but they are persuasive. The 35 U.S.C. 112(a) rejection of all claims has been withdrawn.
Regarding the 35 U.S.C. 112(a) rejection applicant asserts that the skilled person would recognize the claimed formulation in the specification (Pg. 11-12). Specifically, applicant makes three particular points at the end of Pg. 11. In regard to the second of those points applicant makes a citation to Pg. 12 of the specification as allegedly discussing “the potential pitfalls of including ethanol in a formulation including HFO-1234ze(E). It is respectfully submitted that Pg. 12 appears to only substantiate inclusion of ethanol, and not exclusion, by way at least of its statement in Ln. 14-17 that “inclusion of ethanol in HFO-1234ze(E) suspensions beyond an effective minimal level (emphasis added) to effectively reduce API deposition and achieve effective overall dose delivery, will adversely impact on other important suspension formulation performance characteristics” which appears to require at least some ethanol (i.e. “an effective minimal level”).
However, another full review of the specification brings attention to Example 12 on Pg. 36. While the specification repeatedly discusses the benefits of limited amounts of ethanol (e.g. Pg. 27, Ln. 1-7 and Table 2 on Pg. 26; Pg. 27, Ln. 25 – Pg. 28, Ln. 9 and Table 3 on Pg. 27; Pg. 30, Ln. 4-6; Pg. 31, Ln. 22-31 and Table 6 on Pg. 31-32; Pg. 34, Ln. 21 – Pg. 35, Ln. 11 and Table 9 on Pg. 34; Pg. 36, Ln. 1-3 and Table 10 on Pg. 35) the data in Table 11 of Example 12 do show both 1) a potential benefit to exclusion of ethanol (e.g. increased mean TUL delivered dose) and that 2) exclusion of ethanol can result in a suitable composition (in alignment with applicant’s assertion regarding the discussion on Pg. 4, Ln. 15-22 of the specification). The prior 35 U.S.C. 112(a) rejection is thus withdrawn.
Applicant’s arguments, see Pg. 12-15, filed 21 Aug 2025, with respect to the 35 U.S.C. 103 rejection of claims 21, 32, 37, 41, and 42 have been fully considered but they are not persuasive. Applicant asserts that a person skilled in the art would not have been led to prepare a formulation of between 0.01 wt% and 0.1 wt% of PEG in HFO-1234ze(E) based upon the cited prior art (Pg. 13-15). Applicant correctly asserts that the examples shown in Tables 2-4 of Stein et al. (U.S. Pub. 2017/0189329) use more PEG than is recited by the present independent claims (Pg. 13).
Applicant then notes the citation made in the prior Office action to ¶0048 of Stein (Pg. 13). Applicant then asserts that a skilled person viewing Stein would not have expected a formulation with HFO-1234ze(E) to be suitable with such a low amount of PEG while also excluding other traditional excipients such as ethanol and PVP (Pg. 14).
It is respectfully submitted this argument is not convincing. It is acknowledged that the specific example in Tables 2-4 of Stein do not use HFO-1234ze(E). However, Stein discusses HFO-1234ze(E) as a particular form of propellant from which a composition can be made according to the disclosure of Stein (¶0050).
Stein discusses PEG as its “first solubilized excipient” and in ¶0048 discusses first a wider range of weight % and then a smaller range of weight % from which PEG can be selected. Notably, in each of those ranges the lower end of the range is 0.01 wt %. Thus, one of ordinary skill in the art would have considered it prima facie obvious to use 0.01 wt % as a minimum amount when testing any possible composition in line with the disclosure of Stein.
Stein then discusses in ¶0057 that in any embodiment an “optional second solubilized excipient” can be included. One of ordinary skill in the art would obviously conclude from the term “optional” that the second solubilized excipient does not need to be present, which at least corresponds to the Example 1 formulation in Table 2 which only uses PEG 1000 as an excipient.
It is thus respectfully submitted that the overall disclosure of Stein and Joshi still accurate render each of the independent claims as prima facie obvious under 35 U.S.C. 103. The prior 35 U.S.C. 103 rejections are thus maintained.
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claim(s) 21-25, 27, 29-35, and 37-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein et al. (U.S. Pub. 2017/0189329) in view of Joshi et al. (U.S. Pub. 2023/0026203).
Regarding claim 21, Stein discloses a metered dose inhaler (¶¶0010, 0056) comprising: a metering valve (e.g. ¶¶0010, 0021, 0074); a canister (e.g. ¶¶0021, 0078); and an actuator (¶¶0056, 0075); wherein the canister comprises a formulation in the form of a suspension (e.g. ¶¶0010, 0031), comprising: greater than 95% by weight of propellant (e.g. Table 2 in ¶0138); polyethylene glycol (PEG) (¶0048 and Table 2 in ¶0138), wherein the PEG is solubilized in the propellant (¶0048); and suspended particles (e.g. ¶0012) comprising: at least one active pharmaceutical ingredient (API) (e.g. Table 2 in ¶0138) comprising: a formoterol salt or solvate (Table 2 in ¶0138); and a corticosteroid (Budesonide in Table 2 in ¶0138); wherein the formulation does not include ethanol (¶0067 – “free of an alcoholic co-solvent” and Table 2 in ¶0138 has no ethanol discussed) or polyvinylpyrrolidone (PVP) (e.g. Table 2 in ¶0138 Example 1 with 0 g PVP K25). The claim is afforded an effective filing date of 08 Sep 2022 as there is not found to be support for the overall claimed invention in any of the provisional applications to which the instant application claims priority benefit. Note also the discussion in ¶¶0043-0044 of alternative second solubilized excipients other than PVP.
Stein fails to explicitly disclose the actuator comprising an actuator nozzle; the propellant being HFO-1234ze(E) at greater than 95% by weight; and the PEG at a concentration of between 0.01 wt% and 0.1 wt%.
However, Stein teaches ranges from which PEG can be selected with a lower end of the range each time as 0.01 wt% (¶0048). Stein thus suggests as prima facie obvious the use of 0.01 wt % as a minimum amount of PEG when testing any possible composition.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Stein the PEG at a concentration of 0.01 wt% based upon the suggestion in Stein that 0.01 wt % is a desirable minimum amount of PEG when testing any possible composition.
Joshi teaches a MDI and teaches actuators in the art as known to include an actuator nozzle (¶¶0195, 0201).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Stein the actuator comprising an actuator nozzle based upon the common usage in the MDI art of an actuator nozzle in an actuator in view of Joshi.
Stein teaches use of propellant at greater than 95% by weight (e.g. Table 2 in ¶0138). Stein also teaches that the propellant can be HFO-1234ze (¶0050). Joshi, as introduced above, teaches HFO-1234ze(E) as a particular pharmaceutical grade form of HFO-1234ze which is in compliance with the GMP regulations for use in humans and consistent with major health authorities' guidelines (¶0128).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Stein the propellant being HFO-1234ze(E) at greater than 95% by weight based upon an obvious design choice to select a particular pharmaceutical grade form of HFO-1234ze which is in compliance with the GMP regulations for use in humans and consistent with major health authorities' guidelines, in view of Joshi, together with the teaching in Stein that HFO-1234ze would be a suitable propellant alternative.
Regarding claim 22, Stein further teaches the corticosteroid comprises budesonide (e.g. Table 2 in ¶0138) or mometasone.
Regarding claim 23, Stein teaches the invention as modified above and Joshi as incorporated therein further teaches the formulation comprises the active pharmaceutical ingredient to deliver an amount greater than 0.001 mg/actuation (e.g. ¶0183 – per inhalation dose).
Regarding claim 24, Stein teaches the invention as modified above and Joshi as incorporated therein further teaches the formulation comprises the active pharmaceutical ingredient to deliver an amount less than 0.5 mg/actuation (e.g. ¶0183 – per inhalation dose).
Regarding claim 25, Stein further suggests as obvious HFO-1234ze(E) is the sole propellant (note none of the example formulations in Tables 2-4 use multiple propellants). Note further the discussion in Joshi of an absence of impurities (¶0128).
Regarding claim 27, Stein further teaches the PEG comprises PEG 1000 (Table 2 in ¶0138) or PEG 300.
Regarding claim 29, Stein teaches the invention as modified above and Joshi as incorporated therein further teaches the metering valve has a size of 25 µL, 50 µL (¶0287), or 63 µL (¶0201).
Regarding claim 30, Stein further teaches the actuator nozzle comprises an exit orifice effective diameter of 0.12 mm to 0.5 mm (¶0075).
Regarding claim 31, Joshi further teaches the formoterol comprises formoterol fumarate (e.g. Table 2 in ¶0138).
Regarding claim 32, Stein discloses a metered dose inhaler (¶¶0010, 0056) comprising: a metering valve (e.g. ¶¶0010, 0021, 0074); a canister (e.g. ¶¶0021, 0078); and an actuator (¶¶0056, 0075); wherein the canister comprises a formulation in the form of a suspension (e.g. ¶¶0010, 0031), comprising: greater than 98% by weight of the propellant (e.g. Table 2 in ¶0138); PEG 1000 (¶0048 and Table 2 in ¶0138), wherein the PEG 1000 is solubilized in the propellant (¶0048); and suspended particles (e.g. ¶0012) comprising: an API (e.g. Table 2 in ¶0138) comprising formoterol fumarate (e.g. Table 2 in ¶0138) and budesonide (e.g. Table 2 in ¶0138); wherein the formulation does not include ethanol (¶0067 – “free of an alcoholic co-solvent” and Table 2 in ¶0138 has no ethanol discussed) or polyvinylpyrrolidone (PVP) (e.g. Table 2 in ¶0138 Example 1 with 0 g PVP K25). The claim is afforded an effective filing date of 08 Sep 2022 as there is not found to be support for the overall claimed invention in any of the provisional applications to which the instant application claims priority benefit. Note also the discussion in ¶¶0043-0044 of alternative second solubilized excipients other than PVP.
Stein fails to explicitly disclose the actuator comprising an actuator nozzle; the propellant being HFO-1234ze(E) at greater than 98% by weight; and the PEG at a concentration of between 0.01 wt% and 0.1 wt%.
However, Stein teaches ranges from which PEG can be selected with a lower end of the range each time as 0.01 wt% (¶0048). Stein thus suggests as prima facie obvious the use of 0.01 wt % as a minimum amount of PEG when testing any possible composition.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Stein the PEG at a concentration of 0.01 wt% based upon the suggestion in Stein that 0.01 wt % is a desirable minimum amount of PEG when testing any possible composition.
Joshi teaches a MDI and teaches actuators in the art as known to include an actuator nozzle (¶¶0195, 0201).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Stein the actuator comprising an actuator nozzle based upon the common usage in the MDI art of an actuator nozzle in an actuator in view of Joshi.
Stein teaches use of propellant at greater than 98% by weight (e.g. Table 2 in ¶0138). Stein also teaches that the propellant can be HFO-1234ze (¶0050). Joshi, as introduced above, teaches HFO-1234ze(E) as a particular pharmaceutical grade form of HFO-1234ze which is in compliance with the GMP regulations for use in humans and consistent with major health authorities' guidelines (¶0128).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Stein the propellant being HFO-1234ze(E) at greater than 98% by weight based upon an obvious design choice to select a particular pharmaceutical grade form of HFO-1234ze which is in compliance with the GMP regulations for use in humans and consistent with major health authorities' guidelines, in view of Joshi, together with the teaching in Stein that HFO-1234ze would be a suitable propellant alternative.
Regarding claim 33, Stein further suggests as obvious HFO-1234ze(E) is the sole propellant (note none of the example formulations in Tables 2-4 use multiple propellants). Note further the discussion in Joshi of an absence of impurities (¶0128).
Regarding claim 34, Stein further teaches the formulation comprises 0.05 wt% to 1.0 wt% of budesonide (e.g. Table 2 in ¶0138).
Regarding claim 35, Stein teaches the invention as modified above and Joshi as incorporated therein further teaches the formulation includes budesonide in an amount of 50 µg/actuation to 200 µg/actuation (¶0183 – between 70 µg/inhalation to 170 µg/ inhalation) and wherein the formulation includes formoterol fumarate at in an amount of 1 µg/actuation to 10 µg/actuation (¶0183 – between 1 µg/inhalation to 5 µg/ inhalation). Note further than one of ordinary skill in the art considering the mass amounts of budesonide and formoterol fumarate in Table 4 of Stein when considering that a standard canister has a set expected number of dosages would obviously have arrived at values within the claimed ranges based upon performing a simple calculation of total drug amount to number of expected dosages in the canister.
Regarding claim 37, Stein discloses a metered dose inhaler (¶¶0010, 0056) comprising: a metering valve (e.g. ¶¶0010, 0021, 0074); a canister (e.g. ¶¶0021, 0078); and an actuator (¶¶0056, 0075); wherein the canister comprises a formulation in the form of a suspension (e.g. ¶¶0010, 0031), comprising: greater than 98% by weight of propellant (e.g. Table 2 in ¶0138); PEG 1000 (¶0048 and Table 2 in ¶0138), wherein the PEG 1000 is solubilized in the propellant (¶0048); and suspended particles (e.g. ¶0012) comprising: an API (e.g. Table 2 in ¶0138) comprising formoterol fumarate (e.g. Table 2 in ¶0138) and mometasone furoate (¶0034 – included in combinations); wherein the formulation does not include ethanol (¶0067 – “free of an alcoholic co-solvent” and Table 2 in ¶0138 has no ethanol discussed) or polyvinylpyrrolidone (PVP) (e.g. Table 2 in ¶0138 Example 1 with 0 g PVP K25). The claim is afforded an effective filing date of 08 Sep 2022 as there is not found to be support for the overall claimed invention in any of the provisional applications to which the instant application claims priority benefit. Note also the discussion in ¶¶0043-0044 of alternative second solubilized excipients other than PVP.
Stein fails to explicitly disclose the actuator comprising an actuator nozzle; the propellant being HFO-1234ze(E) at greater than 98% by weight; and the PEG at a concentration of between 0.01 wt% and 0.1 wt%.
However, Stein teaches ranges from which PEG can be selected with a lower end of the range each time as 0.01 wt% (¶0048). Stein thus suggests as prima facie obvious the use of 0.01 wt % as a minimum amount of PEG when testing any possible composition.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Stein the PEG at a concentration of 0.01 wt% based upon the suggestion in Stein that 0.01 wt % is a desirable minimum amount of PEG when testing any possible composition.
Joshi teaches a MDI and teaches actuators in the art as known to include an actuator nozzle (¶¶0195, 0201).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Stein the actuator comprising an actuator nozzle based upon the common usage in the MDI art of an actuator nozzle in an actuator in view of Joshi.
Stein teaches use of propellant at greater than 98% by weight (e.g. Table 2 in ¶0138). Stein also teaches that the propellant can be HFO-1234ze (¶0050). Joshi, as introduced above, teaches HFO-1234ze(E) as a particular pharmaceutical grade form of HFO-1234ze which is in compliance with the GMP regulations for use in humans and consistent with major health authorities' guidelines (¶0128).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Stein the propellant being HFO-1234ze(E) at greater than 98% by weight based upon an obvious design choice to select a particular pharmaceutical grade form of HFO-1234ze which is in compliance with the GMP regulations for use in humans and consistent with major health authorities' guidelines, in view of Joshi, together with the teaching in Stein that HFO-1234ze would be a suitable propellant alternative.
Regarding claim 38, Stein further suggests as obvious HFO-1234ze(E) is the sole propellant (note none of the example formulations in Tables 2-4 use multiple propellants). Note further the discussion in Joshi of an absence of impurities (¶0128).
Regarding claim 39, Stein teaches the invention as modified above and Joshi as incorporated therein further teaches the formulation comprises 0.05 wt% and 1.0 wt% of mometasone furoate (¶¶0161-0162, 0183). Note the weight/weight teachings in ¶0183 in regard to budesonide which fall within the recited range. Then note the overlapping target delivered dose amounts discussed on mometasone in ¶0161 and budesonide in ¶0162. Based upon the overlapping target delivered dose amounts in those two paragraphs one of ordinary skill in the art would have considered it prima facie obvious for mometasone to be provided in a wt% similar to that discussed in at least ¶0183 in regard to budesonide.
Regarding claim 40, Stein teaches the invention as modified above and Joshi as incorporated therein further teaches and wherein the formulation includes mometasone furoate in an amount of 50 µg/actuation to 200 µg/actuation (¶0161 – between 50 µg/inhalation to 200 µg/ inhalation) and wherein the formulation includes formoterol fumarate at in an amount of 1 µg/actuation to 10 µg/actuation (¶0183 – between 1 µg/inhalation to 5 µg/ inhalation).
Regarding claim 41, Stein discloses a metered dose inhaler (¶¶0010, 0056) comprising: a metering valve (e.g. ¶¶0010, 0021, 0074); a canister (e.g. ¶¶0021, 0078); and an actuator (¶¶0056, 0075); wherein the canister comprises a formulation in the form of a suspension (e.g. ¶¶0010, 0031), comprising: greater than 95% by weight of propellant (e.g. Table 2 in ¶0138); an excipient consisting of PEG (e.g. Table 2 in ¶0138 Example 1 with 9.0 g PEG 1000 and 0 g PVP K25), wherein the PEG is solubilized in the propellant (¶0048); and suspended particles (e.g. ¶0012) comprising: at least one API (e.g. Table 2 in ¶0138) comprising a formoterol salt or solvate (Table 2 in ¶0138); and a corticosteroid (Budesonide in Table 2 in ¶0138). The claim is afforded an effective filing date of 08 Sep 2022 as there is not found to be support for the overall claimed invention in any of the provisional applications to which the instant application claims priority benefit.
Stein fails to explicitly disclose the actuator comprising an actuator nozzle; the propellant being HFO-1234ze(E) at greater than 95% by weight; and the PEG at a concentration of between 0.01 wt% and 0.1 wt%.
However, Stein teaches ranges from which PEG can be selected with a lower end of the range each time as 0.01 wt% (¶0048). Stein thus suggests as prima facie obvious the use of 0.01 wt % as a minimum amount of PEG when testing any possible composition.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Stein the PEG at a concentration of 0.01 wt% based upon the suggestion in Stein that 0.01 wt % is a desirable minimum amount of PEG when testing any possible composition.
Joshi teaches a MDI and teaches actuators in the art as known to include an actuator nozzle (¶¶0195, 0201).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Stein the actuator comprising an actuator nozzle based upon the common usage in the MDI art of an actuator nozzle in an actuator in view of Joshi.
Stein teaches use of propellant at greater than 95% by weight (e.g. Table 2 in ¶0138). Stein also teaches that the propellant can be HFO-1234ze (¶0050). Joshi, as introduced above, teaches HFO-1234ze(E) as a particular pharmaceutical grade form of HFO-1234ze which is in compliance with the GMP regulations for use in humans and consistent with major health authorities' guidelines (¶0128).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Stein the propellant being HFO-1234ze(E) at greater than 95% by weight based upon an obvious design choice to select a particular pharmaceutical grade form of HFO-1234ze which is in compliance with the GMP regulations for use in humans and consistent with major health authorities' guidelines, in view of Joshi, together with the teaching in Stein that HFO-1234ze would be a suitable propellant alternative.
Regarding claim 42, Stein discloses a metered dose inhaler (¶¶0010, 0056) comprising: a metering valve (e.g. ¶¶0010, 0021, 0074); a canister (e.g. ¶¶0021, 0078); and an actuator (¶¶0056, 0075); wherein the canister comprises a formulation in the form of a suspension (e.g. ¶¶0010, 0031) consisting of (e.g. Table 2 in ¶0138 Example 1 with 0 g PVP K25): greater than 95% by weight of propellant (e.g. Table 2 in ¶0138); PEG (e.g. Table 2 in ¶0138), wherein the PEG is solubilized in the propellant (¶0048); and suspended particles (e.g. ¶0012) comprising: at least one API (e.g. Table 2 in ¶0138) comprising a formoterol salt or solvate (Table 2 in ¶0138); and a corticosteroid (Budesonide in Table 2 in ¶0138). The claim is afforded an effective filing date of 08 Sep 2022 as there is not found to be support for the overall claimed invention in any of the provisional applications to which the instant application claims priority benefit.
Stein fails to explicitly disclose the actuator comprising an actuator nozzle; the propellant being HFO-1234ze(E) at greater than 95% by weight; and the PEG at a concentration of between 0.01 wt% and 0.1 wt%.
However, Stein teaches ranges from which PEG can be selected with a lower end of the range each time as 0.01 wt% (¶0048). Stein thus suggests as prima facie obvious the use of 0.01 wt % as a minimum amount of PEG when testing any possible composition.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Stein the PEG at a concentration of 0.01 wt% based upon the suggestion in Stein that 0.01 wt % is a desirable minimum amount of PEG when testing any possible composition.
Joshi teaches a MDI and teaches actuators in the art as known to include an actuator nozzle (¶¶0195, 0201).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Stein the actuator comprising an actuator nozzle based upon the common usage in the MDI art of an actuator nozzle in an actuator in view of Joshi.
Stein teaches use of propellant at greater than 95% by weight (e.g. Table 2 in ¶0138). Stein also teaches that the propellant can be HFO-1234ze (¶0050). Joshi, as introduced above, teaches HFO-1234ze(E) as a particular pharmaceutical grade form of HFO-1234ze which is in compliance with the GMP regulations for use in humans and consistent with major health authorities' guidelines (¶0128).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Stein the propellant being HFO-1234ze(E) at greater than 95% by weight based upon an obvious design choice to select a particular pharmaceutical grade form of HFO-1234ze which is in compliance with the GMP regulations for use in humans and consistent with major health authorities' guidelines, in view of Joshi, together with the teaching in Stein that HFO-1234ze would be a suitable propellant alternative.
Allowable Subject Matter
Claim 43 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 43, Stein fails to teach or suggest the formulation comprises 0.05 wt% of the PEG. One specific example in Stein uses 0.3 wt% PEG 1000 (Table 2 in ¶0138), an amount much greater than the claimed amount. In ¶0048 Stein discusses broad ranges of PEG would can be used, such as “about 0.01 to about 1.0 weight %.” However, given the combination of the width of that range in ¶0048 together with the relatively large PEG 1000 amount used in the specific examples of ¶0138 there is not a preponderance of the evidence that one of ordinary skill in the art would have obviously selected the exact amount of 0.05 wt% for the amount of PEG to include in a formulation which also includes all of the other elements required by claim 21.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
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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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785