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 .
DETAILED ACTION
Claims 1, 2 and 4-10 are currently pending and a preliminary amendment to the claims filed on 06/14/2024 is acknowledged.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/14/2024 was filed before the mailing date of the instant first action on the merits. The submission thereof is in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statement has been considered by the examiner, and signed and initialed copy is enclosed herewith.
Claim Objections
Claims 1, 2 and 4-8 are objected to because of the following informalities:
Claim 1 (b) recites “1,1-difluoroethane (R-152a)”, but which is better to write “1,1-dilfuloroethane (also called R-152a)”.
Each of claims 1, 7 and 8 would be better to recite as follows:
Claim 1, line 1 [Wingdings font/0xE0] “A pharmaceutical composition …”.
Claim 7, line 1 [Wingdings font/0xE0] “A cannister comprising the pharmaceutical composition …”.
Claim 8, line 1 [Wingdings font/0xE0] “A metered-dose inhaler (MD) provided with the canister …”.
Each of claims 2 and 4-6 would be better to recite as follows:
Claim 2, line 1 [Wingdings font/0xE0] “The pharmaceutical composition …”.
Claim 4, line 1 [Wingdings font/0xE0] “The pharmaceutical composition …”.
Claim 5, line 1 [Wingdings font/0xE0] “The pharmaceutical composition …”.
Claim 6, line 1 [Wingdings font/0xE0] “The pharmaceutical composition …”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 9-10 are rejected under 35 U.S.C. § 101 as being drawn to “use” claims, which are non-statutory category, as defined in 35 U.S.C. § 101. See, Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967).
That is, the claimed invention recited claims 9-10 is directed to non-statutory subject matter. Claims 9-10 do not fall within at least one of the four categories of patent eligible subject matter because they recite “use category”.
Appropriate correction is requested.
Until the applicant amends them to recite proper category, the examination of a prior art rejection will not be initiated.
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 2, 4-6 and 9-10 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 2 recites the broad recitation “the mass proportion of active ingredient (a) is between 0.05% and 0.5% by mass”, and the claim also recites “advantageously between 0.1% and 0.4% by mass”, and “preferably, between 0.2% and 0.35% by mass”, which is the narrower statements of the range/limitation. Claims 4-6 reciting narrower languages led by “in particular, advantageously, preferably (claims 4-5) and “such as” (claim 6) also have the same issues. Thus, claims 2 and 4-6 are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Each of claims 9-10 is vague and indefinite in its recitation of the phrase "use of the pharmaceutical composition…" (claim 9) and “use of the canister…” (claim 10). More specifically, each of claims is rendered indefinite when said claims merely recite a use without any active, positive steps delimiting how this use is actually practiced. See MPEP 2175.03(q). The claims should be redrafted such that they recite statutory category format.
Appropriate correction is requested.
Until the applicant amends them to recite proper category, the examination of a prior art rejection will not be initiated.
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.
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.
Claims 1, 2 and 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Noakes et al. (US2021/0244688A1, IDS of 06/14/2024) in view of Ruffin et al., “A comparative bronchodilator study of salbutamol and salbutamol sulphate that were administered by metered-dose inhalers”, Therapeutics, March 6, 1989, vol. 150, pp. 274-277.
Applicant claims the below claim 1 filed on 06/14/2024:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “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 level of skill is that of a medical/pharmaceutical composition containing salbutamol sulphate for use in treating respiratory disorder research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art (MPEP 2141.01)
Noakes teaches an embodiment of a pharmaceutical composition consists of drug salbutamol base, propellant 1,1-difluoroethane (HFA-152a or R-152a), and polar excipient ethanol (see, e.g., Example 1: [0128]) (instant claim 1, in part); the salbutamol is used in an amount of 0.01 to 2.5% (see, e.g., [0028]) that overlaps the instant range of between 0.05% and 0.5%. MPEP 2144.05 states that [I]n 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) (instant claim 2); the propellant 1,1-difluoroethane is used in an amount of 92.5 to 99.5% (see, e.g., [0033]) that overlaps the instant range of between 94.5% and 99.9%. MPEP 2144.05 noted above (instant claim 4); the polar excipient ethanol is used in an amount of 0.5 to 25% (see, e.g., [0035]) that overlaps the instant range of between 0.05% and 10% MPEP 2144.05 noted above (instant claim 5); instant claim 6 recites an intended use of product, but which is not structurally limiting the product, and thus when the prior art teaches the claimed composition, such intended uses are implicit. Nevertheless, Noakes discloses the composition is used for treating a respiratory disorder selected from asthma or chronic obstructive pulmonary disease (claims 49-50 of prior art)(instant claim 6); and the composition is delivered using a medical device, such as a metered dose inhaler (MDI) wherein the composition is stored in container or canister ([0115] and claims 45-47)(instant claims 7-8).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the claimed invention and Noakes is that Noakes does not expressly teach salbutamol sulphate as claimed. This deficiency in Noakes is cured by the teachings of Ruffin.
Ruffin discloses a comparative bronchodilator study of salbutamol and salbutamol sulphate that were administered by metered-dose inhalers (title); each 200 µg of salbutamol and salbutamol sulphate were administered to the patients having asthma by metered-dose inhalers, and no clinically-significant difference occurs between the bronchodilator effects of salbutamol and those of salbutamol sulphate, with different propellant mixtures, dispersed agents and valvular system (see, entire document including e.g., abstract).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to replace salbutamol of Noakes with salbutamol sulphate, as suggested by Ruffin, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because both compounds are equivalent in the treatment of respiratory disorder including asthma and thus such replacement would have yielded no more than the predictable therapeutic effects.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 2 and 4-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending application No. 18/992711.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require salbutamol sulphate, 1,1-difuloroethane (R-152a), ethanol, and overlapping or identical amounts thereof. The difference between them is that copending ‘711 further requires polyethylene glycol (PEG) as surfactant. However, the copending ‘711 application discloses surfactant can be optional ingredient (see entire document including Table 1).
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter.
This is a provisional double patenting rejection since the conflicting claims have not yet been patented.
Conclusion
All examined claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613
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