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 1-28, 30 and 31 are pending.
Election/Restrictions
Applicant's election with traverse of the invention of Group I, claims 1-28, drawn to a pharmaceutical composition and container, and the species of:
Species (a): formoterol fumarate as species of LABA agent;
Species (b): EDTANa₄ as species of chelating agent;
Species (c): corticosteroid is present, and is beclometasone (BDP);
Species (d): HFA 152a as species of propellant; and
Species (e): FEP as species of canister coating,
in the reply filed on 9/15/26 is acknowledged. The traversal is on the ground(s) that the Office has not provided any reasons or examples to support a conclusion that the species are indeed patentably distinct, and the Office has not considered the relationship of the inventions of Groups I -- II with respect to MPEP $806.03.
This is not found persuasive because the portions of the MPEP cited by Applicant do not pertain to national stage applications filed under 35 U.S.C 371. The analysis used to determine whether the Office may require restriction differs in national stage applications submitted under 35 U.S.C. 371 (unity of invention analysis) as compared to national applications filed under 35 U.S.C. 111(a) (independent and distinct analysis) (see MPEP 1893.03(d)). As described supra, the groups of inventions lack unity of invention because even though the inventions of these groups require the technical feature of a composition comprising a LABA agent, a cosolvent, a propellant, and a chelating agent, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Keller et al.
Applicant further submits that the Examiner has not provided any indication that the content of the claims interpreted in light of the description was considered in making the assertion of a lack of unity and therefore has not met the burden necessary to support the assertion.
This is not found persuasive because Applicant has not explained what feature(s) they believe the Examiner to have overlooked.
The requirement is still deemed proper and is therefore made FINAL.
Claims 30 and 31 are withdrawn as being drawn to a nonelected invention.
Claims 3, 18, 21, and 22 are withdrawn as not being directed to the elected species of LABA agent, propellant and chelating agents.
Claims 1, 2, 4-17, 19, 20, and 23-28 are under consideration to the extent that the composition comprises the elected species.
Information Disclosure Statement
Acknowledgement is made of Applicant’s information disclosure statements (IDS) submitted on 11/14/24. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
In claim 1, LABA should be included with its full terminology for the first time presented in the claims. “…long acting beta 2 agonist (LABA) agent,…”
In claim 11, “and” should be inserted in line 9 between “rofleponide” and “etiprednol dicloacetate”.
Appropriate correction is required.
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.
Claim 23 is 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 pre-AIA the applicant regards as the invention.
Claim 23 recites the limitation "the total amount of water" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite water. The following is suggested, “…further comprising water [[is]] in an amount from 5000 to 13000 ppm.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 4 recites “wherein the LABA agent is formoterol fumarate”, however, claim 4 depends from claim 3 which recites “wherein the LABA agent is formaterol fumarate dihydrate”.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 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, 4-17, 19, 23 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Keller et al. (US 6,475,467; cited previously) in view of McConville et al. (US 2014/0239525).
Keller et al. teach a medicinal aerosol formulation, comprising a solid, pharmaceutically acceptable salt of at least one compound selected from the group consisting of cromoglycic acid and nedocromil, an efficacious amount of a finely divided pharmaceutically active compound which is different from said salt, having a mean particle diameter of less than 6 μm, and a non-toxic liquid propellant, in which said active compound is present in suspended form (e.g. claim 1).
Keller teach the formulations comprise formoterol fumarate (i.e. elected LABA agent), ethanol (i.e. elected co-solvent), HFA 152a (i.e. elected propellant) and sodium EDTA (i.e. a chelating agent) (e.g. column 5, lines 16-43; column 8, line 59-column 9, line 12; column 7, line 30; column 9, line 31; Examples).
Keller et al. do not teach that the chelating agent/stabilizer is the elected species of EDTANA4. This is made up for by the teachings of McConville et al.
McConville et al. teach Inhalable pharmaceutical compositions (e.g. abstract). McConville et al. teach that the compositions comprise a chelating agent, for example, disodium ethylenediamine tetra acetic acid (EDTA) or tetrasodium EDTA (i.e. EDTANa4) (e.g. paragraph 0110).
Regarding Claims 1, 2, 4, 5, 14-17, and 19, it would have been obvious to one of ordinary skill in the art at the time of filing to replace the sodium EDTA of Keller et al. with the tetrasodium EDTA (EDTANa4) of McConville et al. because they are functional equivalents and simple substitution of one known element for another to obtain predictable results is obvious. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results.
Regarding Claims 6-10, Keller et al. teach that the stabilizers are present at 0.0001 to 1% by weight, which overlaps with the claimed ranges (e.g. column 9, lines 29-35). 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) (MPEP 2144.05.I).
Regarding Claims 11-13, Keller et al. further teach the inclusion of beclomethasone, and specifically mixtures of LABA agents and corticosteroids (e.g. column 5, lines 13-33; Claims 8 and 10).
Regarding Claim 23, Keller et al. teach that water may be present in less than 5% by weight, which overlaps with the claimed range (e.g. column 8, line 59-column 9, line 13). 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) (MPEP 2144.05.I).
Regarding Claim 26, Keller et al. further teach the inclusion of a pressure-resistant containers which can be equipped with metered-dose valves (i.e. pMDI) (e.g. column 8, lines 53-58).
Claims 24, 25, 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Keller et al. (US 6,475,467; cited previously) in view of McConville et al. (US 2014/0239525) as applied to claims 1, 2, 4-17, 19, 23 and 26, and further in view of Brugger et al. (US 6,596,260).
Regarding Claims 1, 2, 4-17, 19, 23 and 26, the teachings of Keller et al. and McConville et al. are described supra. Keller et al. further teach the inclusion of a pressure-resistant containers which can be equipped with metered-dose valves (i.e. pMDI) (e.g. column 8, lines 53-58). They do not describe the details of the containers or internal coatings. This is made up for by the teachings of Brugger et al.
Brugger et al. teach an aerosol container for metering and administering pharmaceutically active aerosols that are to be administered in predetermined amounts comprising a pharmaceutically active substance and at least a propellant gas. The aerosol container has a metering valve that comprises a metering chamber and a valve stem, and the inner wall of the container is coated with a plastics coating (e.g. abstract; Claim 1; Figure). Brugger et al. teach that the inner wall of the container is coated with a plastics coating which may be perfluoroethylenepropylene (i.e. FEP). The use of the coating prevents significant deposits of the active substance on the inner wall of the container and effects of corrosion and electrolysis between the container wall and the liquid or suspension are also avoided (e.g. column 4, lines 19-31; Claim 2).
Regarding Claims 24, 25, 27 and 28, it would have been obvious to one of ordinary skill in the art at the time of filing to select the device of Brugger et al. for use with the composition of Keller et al. and McConville et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as all of the references are directed to inhaled pharmaceutical compositions and one of ordinary skill would have been motivated in order to select the device of Brugger et al. to provide the benefits of the prevention of significant deposits of active substance on the inner wall of the container and avoiding the effects of corrosion and electrolysis between the container wall and the liquid (e.g. column 4, lines 19-31; Claim 2).
Claims 1, 2, 4-17, 19, 20, and 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over Malhorta et al. (US 2014/0147393) in view of McConville et al. (US 2014/0239525).
Malhorta et al. teach a pharmaceutical composition that includes a beta2-agonist selected from indacaterol and formoterol in combination with a corticosteroid selected from fluticasone and ciclesonide, and, optionally, one or more pharmaceutically acceptable excipients (e.g. abstract).
Malhorta et al. teach the formulations comprise formoterol fumarate (i.e. elected LABA agent), ethanol (i.e. elected co-solvent), HFA 152a (i.e. elected propellant) and sodium EDTA (i.e. a chelating agent) (e.g. paragraphs 0136, 0138, 0151, 0159; Claim 1; Examples).
Malhorta et al. do not teach that the chelating agent/complexing agent is the elected species of EDTANA4. This is made up for by the teachings of McConville et al.
McConville et al. teach Inhalable pharmaceutical compositions (e.g. abstract). McConville et al. teach that the compositions comprise a chelating agent, for example, disodium ethylenediamine tetra acetic acid (EDTA) or tetrasodium EDTA (i.e. EDTANa4) (e.g. paragraph 0110).
Regarding Claims 1, 2, 4, 5, 14-17, and 19, it would have been obvious to one of ordinary skill in the art at the time of filing to replace the sodium EDTA of Malhorta et al. with the tetrasodium EDTA (EDTANa4) of McConville et al. because they are functional equivalents and simple substitution of one known element for another to obtain predictable results is obvious. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results.
Regarding Claims 6-10, McConville et al. teach that the chelating agents are present at 0.001 to 10% by weight, which overlaps with the range of claim 6 and is near the ranges of claims 7-10 (e.g. paragraph 0110). 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) (MPEP 2144.05.I). In addition, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. In the instant case, 0.00025% EDTANa4 and 0.001% are expected to have the same chelating capability.
Regarding Claims 11-13, Malhorta et al. further teach the inclusion of beclomethasone, and specifically mixtures of LABA agents and corticosteroids (e.g. paragraph 0017; Claim 1).
Regarding Claim 20, Malhorta et al. teach that the compositions are solutions (e.g. Claim 30).
Regarding Claims 24-28, Malhorta et al. further teach the inclusion of a pressurized pMDI which may include an FEP coating (e.g. paragraphs 0132, 0135, 0167).
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-17, 19, 20 and 23-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of copending Application No. 18/865,600 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant and copending claims recite a pharmaceutical composition comprising a LABA agent, a co-solvent, a propellant and a chelating agent (e.g. claims 1). Additional claims are directed to the cannister and a pMDI device comprising the claimed composition.
Claim 1 is met by copending claim 1.
Claims 2-4 are met by copending claims 2-4.
Claim 5 is met by copending claim 7.
Claims 6-10 are met by copending claims 12-20.
Claim 11-13 are met by copending claim 21-23.
Claims 14 and 15 are met by copending claims 24 and 25.
Claims 16, 17 and 19 are met by copending claims 26-29.
Claim 20 is met by copending claim 30.
Claim 23 is met by copending claim 33.
Claims 24-28 are met by copending claims 35-38.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-17, 19, 20 and 23-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of copending Application No. 18/959,958 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant and copending claims recite a pharmaceutical composition comprising a LABA agent, a co-solvent, a propellant and a chelating agent (e.g. claims 1). Additional claims are directed to the cannister and a pMDI device comprising the claimed composition.
Claim 1 is met by copending claim 1.
Claims 2-4 are met by copending claims 2-4.
Claim 5 is met by copending claim 7.
Claims 6-10 are met by copending claims 9-20.
Claim 11-13 are met by copending claim 21-23.
Claims 14 and 15 are met by copending claims 24 and 25.
Claims 16, 17 and 19 are met by copending claims 26-29.
Claim 20 is met by copending claim 30.
Claims 24-28 are met by copending claims 33-36.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
