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 Argument and Amendment
The response filed on 9/26/25 has been entered.
Applicant’s arguments filed 9/26/25 have been fully considered but they are not deemed to be persuasive.
Claims 1-2, 4, 6. 14-15, 17-23, 25, 31-33 are pending in this office action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 4, 6. 14-15, 17-23, 25, 31-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
No proper antecedent basis or conception in context with that described in the specification at the time of filing the instant application is apparent for the recitation of “(hydro)halocarbon other than 1,1- difluoroethane (R-152a)” thereby constituting new matter. Applicant is invited to indicate by page and line number where such a limitation is described.
Maintained Claim Rejections - 35 USC § 103 (necessitated by amendment)
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.
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.
Claim(s) 1-2, 4, 6, 14-15, 17-23, 25, 31-33 stand rejected under 35 U.S.C. 103 as being unpatentable over Stuart et al. (GB 2558191) in view of Di et al. (WO 2009/013213)
Stuart teaches with regards to instant claim 1 a pharmaceutical composition comprising a drug component, a propellant component, i.e., 1,1-difiuoroethane (HFA-152a) in a sealed container (see abstract, claim 26) wherein the vapour pressure can be liquefied (as required by instant claim 4, see sec under pharmaceutical composition) in a pharmaceutical solution (as required by instant claim 17, see claim 25), wherein the valve is then crimped onto the container and the HFA-152a-contalning propellant component. The reference also teaches that the propellant ie, the propellant is from 90-95% of HFA 152a (as required by instant claim 20, see claims 43-44) and the pharmaceutical agent is a corticosteroid (see claim 7 as required by instant claim 23) wherein the corticosteroid is a budesonide (as required by instant claim 25, see claim 8), used as a metered dose inhaler (see claim 28, as required by instant claims 31 and 33) in an aerosolization propellant i.e., an apparatus (as required by instant claim 31).
However fails to teach the purging component comprises a hydrocarbon other than 1,1-difluoroethane (R-152a) and steps as recited by instant claims 1 and 2) and also fails to teach that the propellant is 1,1-difluoroethane (R-152a) and the molecular weight of the propellant. Nonetheless as evidenced by Wikipedia the molecular weight of HFA 152 is from 536 kPa to 510. Therefore it is reasonable that one of ordinary skill in the art would substitute the HFA 152a for R-152a with a reasonable expectation of success and expect the substitution would result in the same as both are the same used in propellants in a medicinal delivery.
Di Giovanni teaches a method of charging an aerosol cannister with a propellant drug formulation by purging the canister (see abstract) wherein the steps are (i) selecting an aerosol canister;
(ii) metering a defined quantity of at least one active drug in dry powder form into said aerosol canister; and
(iii) separately introducing a propellant into the aerosol canister.
And then sealed comprising an active drug and the propellant (i.e., HFA 152a). The reference also teaches that the drug is a corticosteroid such as budesonide (see pg. 19, lines 20+) in a suspension or a liquid (see pg. 26, lines 5+) or a powdered particle. Di Giovanni further teaches that the propellant can or maybe a HFA hydrocarbon (HFA-134a or HFA-227 thus other than HFA 152a for R-152a (see Fig. 3a and 3b).
It would have been obvious to one of ordinary skill in the art to have been motivated to modify Stuart’s teaching to include Ball’s teaching modifying the steps of delivery of a medication by purging the container/canister, introducing the pharmaceutical active agent, seal the container and introduce the propellant with a reasonable expectation of success because even though the steps are not stated as recited by the claims, the modification would have been within the reasoning of a skilled artisan to modify as the Ball reference makes it possible to result in the instant claimed invention. With regards to the fluid component having a reduced flammability relative to the propellant is a result of the composition having the same components as recited by the claims.
Applicant argues that DiGiovanni fails to remedy the teaching of Stuart. Applicant also argues that the rejection relies solely on motivation that the combination is possible.
In response, after careful consideration, this argument is found unpersuasive, because DiGiovanni specifically teach having other (hydro)halocarbons that can be used in purging the cannister. With regards to the statement that the rejection relies solely on motivation that the combination is possible is found unpersuasive because a 103 rejection is based on the on the combination of reference and modification to result in the instant claimed invention. The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The examiner must ascertain what would have been obvious to one of ordinary skill in the art at the time the invention was made, and not to the inventor, a judge, a layman, those skilled in remote arts, or to geniuses in the art at hand. Environmental Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 218 USPQ 865 (Fed. Cir. 1983), cert. denied, 464 U.S. 1043 (1984).
The level of ordinary skill will often predetermine whether an implicit suggestion exists to modify the prior art. Persons of varying degrees of skill not only possess varying bases of knowledge, they also possess varying levels of imagination and ingenuity in the relevant field, particularly with respect to problem-solving abilities. If the level of skill is low, for example that of a mere technician, then it may be rational to assume that such an artisan would not think to combine references absent explicit direction in a prior art reference. If, however, the level of skill is that of a pharmaceutical nanoparticle research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, nanoparticle polymer chemistry— without being told to do so.
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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 6/12/25