DETAILED ACTION
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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-7 and 15-17) in the reply filed on 07/11/2025 is acknowledged. The traversal is on the ground(s) that Applicant notes that the Office has failed to comply with 37 CFR 1.475(b)(3), since all claims are drawn to pharmaceutical compositions. This is not found persuasive because the unity of invention analysis (see MPEP 823 and MPEP 1850), wherein the technical feature of claim 1 does not present a contribution over the prior art, as discussed in the restriction requirement filed on 07/11/2025, and is thus not considered a “special technical feature.”
The requirement is still deemed proper and is therefore made FINAL.
Claims 8-14 and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Groups II and III, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/11/2025.
Priority
The present application is a National Stage entry of International application PCT/EP2021/068958 filed 07/08/2021, which claims the benefit of Foreign application EP20185108.6 filed 07/09/2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 01/06/2023, in the matter of Application N° 18/004,477. Said documents have been entered on the record. The Examiner further acknowledges the following:
Claims 1-17 are pending.
Claims 8-14 and 18 are withdrawn from consideration as directed to non-elected inventions.
Claims 1-7 and 15-17 are presented for examination and rejected as set forth below.
Specification
Note that the Specification was uploaded in a reverse (i.e., backwards) order, making it difficult to read (from pg 41 to 1). This should be reordered for correction.
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 5, 6, and 17 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.
Claims 5 and 6 recite the term “about” to describe numerical values, which is indefinite because it is an imprecise definition of a value. The Examiner suggests “about” should be removed and considers the claim values as if the term “about” was not present.
Claim 17 recites broad and narrow ranges. 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). The claims 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. For examination purposes, the broadest range is used.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7 and 15-17 are rejected as being unpatentable over 35 U.S.C. 102(a1) as anticipated by Andries (WO2019012100A1; cited on the IDS filed 03/09/2023; published 01/17/2019, which is outside the 1-year grace period of the foreign application filing date 07/09/2020).
Applicant’s claims are directed to a suspension composition comprising bedaquiline in micro- or nanoparticle form, a poloxamer, and an aqueous carrier. Note that terms with an intervening forward slash (except for w/v which is understood in the art) will generally be considered as having an “and/or” relationship, unless otherwise amended. Note that amounts in claims 7 and 17, where the ranges reach 0% are considered optional to the composition. The “for administration by intramuscular or subcutaneous injection” is given minimal patentable weight, since the intended use of the formulation does not structurally affect the composition makeup, and only requires an intramuscular or injectable form (e.g., a suspension, which is already a limitation of claim 1).
With respect to the “consisting essentially of” transitional phrase of claim 15, this phrase is treated as equivalent to “comprising.” PPG Industries v. Guardian Industries, 156 F.3d 1351, 1355, 48 USPQ2d at 1355 (Fed. Cir. 1998) (absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising”: "PPG could have defined the scope of the phrase ‘consisting essentially of’ for purposes of its patent by making clear in its specification what it regarded as constituting a material change in the basic and novel characteristics of the invention."). Applicant has not identified the basic and novel characteristics of the invention additional components, and thus, “consisting essentially of” is treated as equivalent to “comprising.” The Examiner only notes that “consisting essentially of” means “consists of poloxamer 338” by example in the Specification (pg 22, paragraph 1), and as such Applicant may amend by rewriting as “consists of” for the intended meaning, as described by the Specification.
Andries discloses a pharmaceutical composition for administration via intramuscular or subcutaneous injection comprising bedaquiline (pg 1, field of invention).
Regarding claims 1-2: Andries teaches a pharmaceutical composition for administration by intramuscular or subcutaneous injection, comprising a therapeutically effective amount of bedaquiline, or a pharmaceutically acceptable salt thereof, in the form of a suspension of micro- or nanoparticles comprising: bedaquiline, a surface modifier that can be a poloxamer, and a pharmaceutically acceptable aqueous carrier (Andries – claims 1 and 2).
Regarding claim 3: Andries teaches bedaquiline is in its non-salt or free form or in the form of a fumarate salt (Andries – claim 3).
Regarding claim 4 and 15: Andries teaches Pluronic F-108, which is a trade name for poloxamer 188 (Andries – claim 4). A PHOSITA would at once envisage a formulation containing only the poloxamer, such as Pluronic F-108, due to limiting the surface modifier to 4 listed ingredients, including a poloxamer (Andries – claim 4). A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)).
Regarding claims 5-6 and 16: Andries teaches the average effective particle size of the bedaquiline, or a pharmaceutically acceptable salt thereof, micro- or nanoparticles is about 130 nm (Andries – claims 5 and 6).
Regarding claims 7 and 17: Andries teaches the same weight-based ranges for the composition (see amounts specifically in, Andries – claim 7).
Because the Andries WIPO reference obeys international claiming conventions, the instantly claimed amounts (and also particle sizes) are “at once envisaged” because the tightest instant ranges reside within the broadest ranges of the primary reference.
Therefore, the reference is deemed to anticipate the instant claims above.
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.
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.
Claims 1-4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hemelryck (Int. J. of Pharm., 2019).
Hemelryck discloses a pharmaceutical composition for administration via intramuscular or subcutaneous injection comprising bedaquiline (abstract).
Regarding claims 1-4: Hemelryck teaches a pharmaceutical composition comprising bedaquiline fumarate salt (reads on instant claims 1(a) and 3) and poloxamer 338 and/or 407 (reads on instant claims 1(a), 2, and 4) in NMP/water mixtures (reads on 1(b)) for injection and sustained-release action (abstract). Hemelryck also teaches long acting injectables comprising the categories of micro- or nanosuspensions and in situ forming gels (pg 2, paragraph 1), thus, providing motivation to develop a suspension formulation with micro- or nanoparticles. Hemelryck teaches the desirability of using poloxamers (i.e., P188 and P338) for their low cost, low toxicity, high water solubility, and their many functions, including to make in situ forming gels that affect in vitro and in vivo drug release (pg 2, left column).
Regarding claim 15: Hemelryck teaches only P338 in a given formulation (Table 3).
Thus, the instant composition is obvious based on the single reference providing the elements and motivation to make the instant composition.
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-7 and 15-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over, and in further view of Andries (WO2019012100A1; cited on the IDS filed 03/09/2023):
claims 1-2, 5-12, and 16-27 of copending Application No. 18/004,464 (reference application)
claims 1-19, 24-25, and 27-37 of copending Application No. 18/004,336 (reference application)
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets teach a suspension composition comprising bedaquiline in micro- or nanoparticle form, a surface modifier, and an aqueous carrier. The copending applications differ only significantly by not including poloxamer as the selected surface modifier.
This is remedied by Andries, who teaches poloxamers for incorporation into the composition as surface modifiers (Andries – claims 1 and 2). One of ordinary skill in the art would have been motivated to modify the teachings of the copending applications by substituting the copending surface modifiers with the poloxamer described by Andries because the applications are directed toward injectable bedaquiline suspension compositions and the poloxamers are stated to function as surface modifiers.
This is a provisional nonstatutory double patenting rejection.
Claims 1-7 and 15-17 are rejected on the ground of statutory double patenting as being unpatentable over Claims 1-8 of Patent 11141384 (same patent family as WO2019012100A1 used in the 103 above).
Both claim sets teach a suspension composition comprising bedaquiline in micro- or nanoparticle form, a surface modifier (poloxamer), and an aqueous carrier in the instant amounts.
Claims 1-7 and 15-17 are rejected on the ground of statutory double patenting as being unpatentable over Claims 1-19 of Patent 12171887 (same patent family as WO2019012100A1 used in the 103 above).
Both claim sets teach a suspension composition comprising bedaquiline in micro- or nanoparticle form, a surface modifier (poloxamer), and an aqueous carrier in the instant amounts.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJAN PRAGANI whose telephone number is (703)756-5319. The examiner can normally be reached 7a-5p EST (M-Th).
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/R.P./Examiner, Art Unit 1614 9/24/25
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614