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 .
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.
DETAILED ACTION
Status of claims
The amendment filed on 01/13/2026 is acknowledged. Claims 14, 15, and 22 have been canceled. Claims 1-13 and 16-21are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 01/13/2026 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. Applicant’s amendments have overcome the 35 U.S.C. 103(a) rejections of claims 1-13 and 16-21 over Van Oort et al. (US 2001/0018916 A1) and HFC-152a (https://web.archive.org/web/20110818063855/https://www.daikin.com/chm/products/pdfDown.php?url=pdf/tds/tds_hfc152a_e.pdf), of claims 14, 15, and 22 over Van Oort et al. (US 2001/0018916 A1), HFC-152a (https://web.archive.org/web/20110818063855/https://www.daikin.com/chm/products/pdfDown.php?url=pdf/tds/tds_hfc152a_e.pdf), and Toneguzzo et al. (US 2013/0104881 A1), of claims 1-13 and 16-21 over Adjei et al. (US 5,676,931), HFC-152a (https://web.archive.org/web/20110818063855/https://www.daikin.com/chm/products/pdfDown.php?url=pdf/tds/tds_hfc152a_e.pdf), of claims 1-22 over Adjei et al. (US 5,676,931), HFC-152a (https://web.archive.org/web/20110818063855/https://www.daikin.com/chm/products/pdfDown.php?url=pdf/tds/tds_hfc152a_e.pdf), and Toneguzzo et al. (US 2013/0104881 A1), of claims 1-13 and 16-21 over Somani et al. (US 5,846,521), HFC-152a (https://web.archive.org/web/20110818063855/https://www.daikin.com/chm/products/pdfDown.php?url=pdf/tds/tds_hfc152a_e.pdf), and Adjei et al. (US 5,676,931), and of claims 1-22 over Van Oort et al. (US 2001/0018916 A1), HFC-152a (https://web.archive.org/web/20110818063855/https://www.daikin.com/chm/products/pdfDown.php?url=pdf/tds/tds_hfc152a_e.pdf), Adjei et al. (US 5,676,931), and Toneguzzo et al. (US 2013/0104881 A1) and nonstatutory obviousness-type double patenting rejection of claims 1-22 over claims 1-8 and 12-16 of U.S. Patent No. 10,959,965 B2 from the previous Office Action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
New ground of rejections necessitated by Applicant’s amendment
The amendments necessitate the following new ground of rejections.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 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.
Claims 1-13 and 16-21 are rejected under 35 U.S.C. 103(a) as being unpatentable over Van Oort et al. (US 2001/0018916 A1) in view of HFC-152a (https://web.archive.org/web/20110818063855/https://www.daikin.com/chm/products/pdfDown.php?url=pdf/tds/tds_hfc152a_e.pdf) and Purewal et al. (US 5,439,670).
Van Oort et al. teach a pressurized aerosol inhalator such as metered dose inhalator (MDI) (the instant claims 12 and 13 and the 1st wherein clause in the instant claim 16) (paragraph 13, 14, 40) comprising
medicament particles (abstract and paragraph 5 and claim 16) including salbutamol sulphate (paragraph 18 and 31 and claim 21),
a propellant such as HFC 152a (the claimed R-152a), HFC-134a, etc., (paragraph 4 and 42 and claim 26), and
a suspending agent (also surfactant) such as lecithin (the claimed surfactant) (the instant claims 1, 3, and 16) (paragraph 40 and 43 and claim 28) and
specified the particulate medicament being added to a blender which contains propellant and suspending agent (the 1st and 2nd wherein clauses in the instant claim 1, the 1st and 2nd wherein clauses in the instant claim 3, and the 2nd and 3rd wherein clauses in the instant claim 16) (paragraph 41).
No other components (including ethanol, a polar compound) are recited as must have components (the 3rd wherein clause the instant claim 1, and the 4th wherein clause in the instant claim 16 and the instant claim 2-5, 17, and 18,).
Oleic acid is taught by Van Oort et al. as an optional component (paragraph 43). Although Van Oort et al. teach oleic acid in example III; it is well-established that consideration of a reference is not limited to the preferred embodiments or working examples, but extends to the entire disclosure for what it fairly teaches, when viewed in light of the submitted knowledge in the art, to a person of ordinary skill in the art. In the instant case, Van Oort et al. teach oleic acid is as an optional component (the 4th wherein clause the instant claim 1 and the instant claim 2-5, 17, and 18, the 3rd wherein clause in the instant claim 3, and the 4th and 5th wherein clauses in the instant claim 16). Please refer to MPEP 2123.I and MPEP 2123.II:
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments.
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.
Furthermore, “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Although Van Oort et al. teach the propellant of a pressurized aerosol inhalator MDI being selected from the group consisting of HFC 152a, HFC-134a, etc., “HFC-152a” teaches HFC-152a having a lower global warming potential in comparison to other fluorocarbons and HFC-152a (100% HFC-152a) being used as an environment-friendly substitute for HFC-134a aerosol propellant (the instant claims 1, 3, 6-11, 16, and 19-21). It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Van Oort et al. and “HFC-152a” to choose HFC 152a as a propellant, among others, in the composition taught by Van Oort et al. HFC-152a having a lower global warming potential in comparison to other fluorocarbons and HFC-152a being used as an environment-friendly substitute for HFC-134a aerosol propellant was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for choosing HFC 152a as a propellant, among others, in the composition taught by Van Oort et al. flows from its being recognized in the prior art as having a lower global warming potential in comparison to other fluorocarbons and HFC-152a being used as an environment-friendly substitute for HFC-134a aerosol propellant.
Van Oort et al. do not specify surfactants including sorbitan monooleate.
This deficiency is cured by Purewal et al. who teach lecithin, sorbitan monooleate, and polyoxyethylene (20) sorbitan monooleate (polysorbate 80) being suitable surfactant (column 5, line 7-28) in pharmaceutical pressurized metered dose inhalers (column 2, line 35-37 and 65) comprising propellant including 152a (claim 2) and dispersed (suspended) active such as salbutamol sulphate (column 6, line12 and line 64).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Van Oort et al. and Purewal et al. to replace the surfactant lecithin in the composition taught by Van Oort et al. with sorbitan monooleate. Both lecithin and sorbitan monooleate being suitable surfactants in pharmaceutical pressurized metered dose inhalers comprising propellant and suspended active such as salbutamol sulphate was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for replacing the surfactant lecithin in the composition taught by Van Oort et al. with sorbitan monooleate flows from both having been used in the prior art, and from both being recognized in the prior art as useful for the same purpose.
Claims 1-13 and 16-21 are rejected under 35 U.S.C. 103(a) as being unpatentable over Adjei et al. (US 5,676,931) in view of HFC-152a (https://web.archive.org/web/20110818063855/https://www.daikin.com/chm/products/pdfDown.php?url=pdf/tds/tds_hfc152a_e.pdf) and Purewal et al. (US 5,439,670).
Adjei et al. teach pharmaceutical compositions for aerosol delivery as a metered dose inhalation (MDI) devices in which a physiologically inert propellant of high vapor pressure is used to discharge a precise amount of medication with each operation, i.e., the claimed pressurized inhalation medicaments in a container with a sealed valve (the instant claims 12 and 13 and the 1st wherein clause in the instant claim 16) (abstracts and column 1, line 17-24);
wherein compositions consisting essentially of (claim 1) (the instant claims 2, 3 4, 5, 17, 18) a medicament and a particulate protective colloid (such as a detergent) in a non-chlorofluorocarbon propellant (the particulate medicament not being complexed with the propellant or the protective colloid, the 2nd wherein clause in the instant claims 1 and 3 and the 3rd wherein clauses in the instant claim 16) (column 6, line 14-29), without surfactants or without cosolvents (such as ethanol) (abstract and column 1, line 43-64 and claim 1);
wherein the medicament includes albuterol (salbutamol) sulfate salt, the protective colloid includes phosphatidic acid (a species of the mixture in lecithin) (claim 4), and the propellant includes Dymel 152a (the claimed R-152a) (i.e., 100% R-152a, the instant claims 1, 3, 6-11 and claims 19-21), etc., (claim 1).
No other must have components are taught by Adjei et al. (the 3rd and 4th wherein clauses in the instant claim 1, the 3rd wherein clause in the instant claim 3, and the 4th and 5th wherein clauses in the instant claim 16, and the instant claim 2, 4, 5, 17, and 18).
Although Adjei et al. do not teach the claimed salbutamol sulphate solid particles being suspended in R-152a propellant/protective colloid mixture in the 1st wherein clause in the instant claims 1 and 3 and the 2nd wherein clause in the instant claim 16, suspending salbutamol sulphate solid particles into a propellant/protective colloid mixture is a product-by-process limitation. The determination of patentability of a product-by-process claim is based on the product itself, not its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process. The salbutamol solid particles and protective colloid particles being suspended in a propellant taught by Adjei et al. and salbutamol solid particles and protective colloid particles being suspended in a propellant recited in the 2nd clause in instant claims 1 and 3 and 3rd clause in the instant claim 16 are the same physical form. The burden is shifted to the applicant to provide evidence to demonstrate that the structure of the claimed mixture resulted from the said process is different from that of mixture taught by Adjei et al. See MPEP 2113.
Although Adjei et al. teach the propellant of a pressurized aerosol inhalator being selected from the group consisting of 152a, 134a, etc., “HFC-152a” teaches HFC-152a having a lower global warming potential in comparison to other fluorocarbons and HFC-152a being used as an environment-friendly substitute for HFC-134a aerosol propellant. It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Adjei et al. and “HFC-152a” to choose HFC 152a (Dymel 152a) as a propellant, among others, in the composition taught by Adjei et al. HFC-152a having a lower global warming potential in comparison to other fluorocarbons and HFC-152a (100% HFC-152a) being used as an environment-friendly substitute for HFC-134a aerosol propellant was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention (the instant claims 1, 3, 6-11, and 19-21). The motivation for choosing HFC 152a as a propellant, among others, in the composition taught by Adjei et al. flows from its being recognized in the prior art as having a lower global warming potential in comparison to other fluorocarbons and HFC-152a being used as an environment-friendly substitute for HFC-134a aerosol propellant.
Adjei et al. do not specify the surfactants including sorbitan monooleate.
This deficiency is cured by Purewal et al. whose teachings are discussed above and applied in the same manner.
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Van Adjei et al. and Purewal et al. to replace lecithin for good dispersion in the composition taught by Adjei et al. with sorbitan monooleate. Both lecithin and sorbitan monooleate being suitable suspending agents in pharmaceutical pressurized metered dose inhalers comprising propellant and suspended active such as salbutamol sulphate was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for replacing the suspending agent lecithin in the composition taught by Adjei et al. with sorbitan monooleate flows from both having been used in the prior art, and from both being recognized in the prior art as useful for the same purpose.
Claims 1-13 and 16-21 are rejected under 35 U.S.C. 103(a) as being unpatentable over Somani et al. (US 5,846,521) in view of HFC-152a (https://web.archive.org/web/20110818063855/https://www.daikin.com/chm/products/pdfDown.php?url=pdf/tds/tds_hfc152a_e.pdf) and Purewal et al. (US 5,439,670).
Somani et al. teach ethanol-free pressurized aerosol inhalator (compositions powdered inhalation medicaments in a container with a sealed valve (column 1, line 13-15, column 4, line 21-61), containing substantially no solvent other than the propellant (abstract, column 1 line 53-57, and claim 3), comprise
a dispersed particulate medicament (column 4, line 21-37) including salbutamol and salt thereof (column 4, line 33-34),
a hydrofluorocarbon propellant including 152a (the claimed R-152a), etc., (column 4, line 4-7, claim 13), and
a polyethoxylated surfactant, for good dispersion, including polysorbate 80 (abstract and column 3, line 44-50).
Somani et al. do not teach any other must have components (the 3rd and 4th wherein clauses in the instant claim 1, the 3rd wherein clause in the instant claim 3, and the 4th and 5th wherein clauses in the instant claim 16, and the instant claim 2, 4, 5, 17, and 18).
Somani et al. do not teach the particulate medicament being complexed with the propellant or the surfactant, i.e., the claimed salbutamol sulphate solid drug particles being suspended in R-152a propellant/surfactant mixture and salbutamol sulphate and surfactant being included in the mixture with the propellant as separate components (the 1st and 2nd wherein clauses in the instant claim 1 the 1st and 2nd wherein clauses in the instant claim 3, and the 2nd and 3rd wherein clauses in the instant claim 16).
Although Somani et al. teach the propellant of a pressurized aerosol inhalator being selected from the group consisting of 152a, 134a, etc., “HFC-152a” teaches HFC-152a having a lower global warming potential in comparison to other fluorocarbons and HFC-152a being used as an environment-friendly substitute for HFC-134a aerosol propellant. It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Somani et al. and “HFC-152a” to choose HFC 152a as a propellant, among others, in the composition taught by Somani et al. HFC-152a having a lower global warming potential in comparison to other fluorocarbons and HFC-152a (100% HFC-152a) being used as an environment-friendly substitute for HFC-134a aerosol propellant was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention (the instant claims 1, 3, 6-11, and 19-21). The motivation for choosing HFC 152a as a propellant, among others, in the composition taught by Somani et al. flows from its being recognized in the prior art as having a lower global warming potential in comparison to other fluorocarbons and HFC-152a being used as an environment-friendly substitute for HFC-134a aerosol propellant.
Somani et al. do not specify: i) the salbutamol salt being salbutamol sulphate in the instant claims 1, 3, and 16; ii) the container being a metered in claims 12, 13, and 16; and iii) the surfactants including sorbitan monooleate (the instant claim 1).
These deficiencies are cured by Purewal et al. whose teachings are discussed above and applied in the same manner.
It would have been prima facie obvious at the time of the invention to a person of ordinary skill in the art to combine the teachings in Somani et al. and Purewal et al. to specify the salbutamol salt in the composition and the container taught by Somani et al. being salbutamol sulphate and a metered, respectively. Incorporating sulphate salt of salbutamol in inhalation composition in metered container was well known to a person of ordinary skill in the art at the time of the invention. The motivation for specifying them flows from their having been used in the prior art, and from their being recognized in the prior art as useful for the same purpose.
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Van Somani et al. and Purewal et al. to replace polysorbate 80 surfactant for good dispersion in the composition taught by Somani et al. with sorbitan monooleate. Both polysorbate 80 and sorbitan monooleate being suitable suspending agents in pharmaceutical pressurized metered dose inhalers comprising propellant and suspended active such as salbutamol sulphate was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for replacing the suspending agent polysorbate 80 in the composition taught by Somani et al. with sorbitan monooleate flows from both having been used in the prior art, and from both being recognized in the prior art as useful for the same purpose.
Response to Applicants’ arguments:
Applicant’s arguments, filed on 01/13/2026, have been fully considered but they are moot in view of new ground of rejections.
Conclusion
No claims are allowed.
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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG YU/
Primary Examiner, Art Unit 1614