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 .
Priority
The instant application claims domestic priority to PRO 62/180,871 filed 06/17/2015. The instant application is a 371 of PCT/EP2016/063609 filed 06/14/2016. The application is a CON of 15/736,865 filed 12/15/2017.
Information Disclosure Statement
The information disclosure statement (IDS) dated 10/02/2024 complies with provisions of 37 CFR 1.97, 1.98 and MPEP §609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
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 6-8 and 22-24 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, claims 6 and 7 recite the broad recitation “the concentration of the compound of formula (I) is between 0.3 to 1.2 mg/ml”, and the claim also recites “(calculated as free base form)” which is the narrower statement of the range/limitation. The claim(s) 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. Claims 8 and 22-24 depend from claims 6 and 7 and are therefore also indefinite.
Claim Rejections - 35 USC § 112
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 12 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 12 depends from claim 1. Claim 12 does not further limit claim 1. 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
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.
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.
A) Claims 1-5, 9, and 12, are rejected under 35 U.S.C. 103 as being unpatentable over Kapsner (WO 2014/191109 A1).
Kapsner teaches a composition with two antibacterial compounds, one of which may be BC-3781, aka instantly claimed formula I, used together within a diluent or carrier. Kapsner recites a composition which may include BC-3781(Kapsner at claim 5) and a carriers, diluents or adjuvants (Kapsner at claim 13). Kapsner further teaches that each of antibacterial compounds may be salts, solvates or hydrates and more specifically salts of citric, lactic, or acetic acid (Kapsner at page 42). Kapsner further teaches that the composition can be administered as an injection intravenously (Kapsner at page 44) and further specifies that for liquid compositions water, aqueous saline, aqueous dextrose or phosphate buffered saline (pH 7-8) would be acceptable excipients and further teaches the inclusion of buffers (Kapsner at pages 44-45).
Kapsner differs from the instant claims in this rejection insofar as it does not teach the combination of the instantly recited components with sufficient specificity for anticipation. Kapsner teaches the components of the instant recited composition and uses each component of their established function in the art but does not explicitly combine the components together into a single embodiment or a preferred composition. However, given the disclosure of each component individually, it would have been prima facie obvious to a person having ordinary skill in the art at a time prior to the filing of the present patent application and following the teachings of Kapsner to have selected and combined known components for their established functions with predictable results. MPEP §2143 and §2144.06(I).
Regarding instant claims 1-5 and 12, Kapsner teaches a composition which comprises instant formula I, in the form of BC-3781 and that the composition may be buffered as a salt using citric acid (Kapsner at page 42). Kapsner teaches that the composition can be administered as an injection intravenously (Kapsner at page 44). Kapsner further teaches the use of liquid excipients and buffers including phosphate buffered saline. It would have been prima facie obvious to one of ordinary skill in the art to have optimized the pH of the composition to an acceptable pH. One of ordinary skill in the art would be familiar with the pHs used in pharmaceutics and would through routine optimization of the addition of buffers have been able to produce the desired pH given the end pH of the salt and the known pH of the excipient of choice. See MPEP 2144.05(II).
Regarding instant claim 9, Kapsner further teaches that each of antibacterial compounds may be salts, solvates or hydrates and more specifically salts of citric, lactic, or acetic acid (Kapsner at page 42).
B) Claims 1-5, 9-12, 16-18, 21 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Riedl (WO 2011/146954 A1) and Kapsner (WO 2014/191109 A1) in view of Brown (WO 2004/089886).
Riedl teaches the structure of instantly clamed Formula (I) (Riedl at page 3) as a crystalline salt. Riedl teaches that the salt can be acetate or L-lactate (Riedl at page 11), Riedl further specifies that the acid can be an organic acid or an inorganic acid and provides additional examples of acids. Riedl teaches there are advantages to a crystalline salt structure focusing on the improved stability (Riedl at page 12). Riedl further discloses specific embodiments of the structure of instantly claimed formula I as salts in table 4, seen below, (Riedl at table 4).
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Riedl teaches that the salt is an active ingredient in combination with a pharmaceutically acceptable carrier or diluent (Riedl at page 11). Riedl teaches that the salts can be used for intravenous applications, i.e. injection (Riedl at page 12), and more specifically that the solubility of the salts in water and aqueous based vehicles such as 0.9% NaCl solution or biorelevant media like FaSSIF and FeSSIF was high making the salts more pharmaceutically viable (Riedl at page 12).
Riedl does not teach that the salt buffering acid is citric acid. The teachings of Kapsner cure this deficit.
Kapsner teaches a composition with two antibacterial compounds, one of which may be BC-3781, used together within a diluent or carrier. Kapsner recites a composition which may include BC-3781(Kapsner at claim 5) and a carriers, diluents or adjuvants (Kapsner at claim 13). Kapsner further teaches that each of antibacterial compounds may be salts, solvates or hydrates and more specifically salts of citric, lactic, or acetic acid (Kapsner at page 42). Kapsner further teaches that the composition can be administered as an injection intravenously (Kapsner at page 44) and further specifies that for liquid compositions water, aqueous saline, aqueous dextrose or phosphate buffered saline (pH 7-8) would be acceptable excipients and further teaches the inclusion of buffers (Kapsner at pages 44-45).
The combined teachings of Riedl and Kapsner do not teach a range of pHs for the intravenous composition. The teachings of Brown cure this deficit.
Brown teaches pleuromutilin derivatives in pharmaceutically acceptable carries used to treat microbial infections. Brown teaches pharmaceutically acceptable acid-addition salts include citrate, acetate and lactate (Brown at page lines 26-35). Brown teaches that the composition can be used in therapy and specifically for treating microbial infections (Brown at page 15). Brown teaches the concentration and dosage of the composition (Brown at pages 16 -17). Brown teaches the use of a pharmaceutically acceptable excipient, diluent or carrier (Brown at pages 17-23), and specifically teaches that the composition may be administered in an injectable form intravenously (Brown at page 18). Brown further specifies that injectable forms have a pH of from 3 to 9 and that the composition may contain buffers (Brown at page 20 line 30 - page 21 line 13).
Brown does not specifically describe instantly claimed formula (I).
It would have been prima facie obvious to one of ordinary skill in the art following the teaching of Riedl to have used citric acid as the buffer for the composition given Riedl teaches the use of acids and Kapsner teaches that citric acid is suitable for the formation of salts. See MPEP § 2144.07. One would have a reasonable expectation of success because both Riedl and Kapsner both teach the instantly claimed formula I as a salt used for its antimicrobial properties in an intravenous injectable form with an aqueous saline or dextrose solution. Furthermore, it would have been prima facie obvious to one of ordinary skill in the art to have selected citrate aka citric acid as a buffer for the composition of Riedl as citrate is known in the art as a common buffering agent see MPEP §2144.07 and is taught in Kapnser and Brown. One of ordinary skill in the art would have the prerequisite skill and knowledge to buffer a composition and optimize the type of buffer, the strength of the buffer solution, and the amount of buffer used to the desired end pH of the composition.
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Riedl and Kapsner teach and IV formulation. It would have been prima facie obvious to one of ordinary skill in the art to have formulated the IV composition of Riedl and Kapsner to a pH which is suitable for IV injection as taught by Brown. See MPEP 2144.05(I). One would have a reasonable expectation of success because both Riedl and Kapsner teach the instantly claimed formula I and Brown teaches a similarly structured pleuromutilin formula as a salt used for its antimicrobial properties in an intravenous injectable form with an aqueous saline or dextrose solution. Furthermore, Brown is used for its teaching of a safe pH range for intravenous compositions rather than for the specific salt. One would be motivated to use a pH range for intravenous compositions that is known to be acceptable in order to have a composition that is easily and correctly administered to a patient.
Regarding instant claim 1-5, Riedl teaches the structure of instantly clamed Formula (I) (Riedl at page 3) as a crystalline salt. Riedl further specifies that the acid can be an organic acid or an inorganic acid and provides additional examples of acids. Kapsner teaches a composition with two antibacterial compounds, one of which may be BC-3781(instantly claimed formula I), used together within a diluent or carrier. Kapsner recites a composition which may include BC-3781(Kapsner at claim 5) and a carriers, diluents or adjuvants (Kapsner at claim 13). Kapsner further teaches that each of antibacterial compounds may be salts, solvates or hydrates and more specifically salts of citric, lactic, or acetic acid (Kapsner at page 42). Riedl and Kapsner teach that the composition is injectable. Brown further specifies that injectable forms have a pH of from 3 to 9 (Brown at page 20 line 30 - page 21 line 13) which overlaps with the instantly claimed pH range of 2 to 6. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 9 and 25, Brown teaches pharmaceutically acceptable acid-addition salts include citrate, acetate and lactate (Brown at page lines 26-35). Kapsner further teaches that each of antibacterial compounds may be salts, solvates or hydrates and more specifically salts of citric, lactic, or acetic acid (Kapsner at page 42). Riedl teaches the structure of instantly clamed Formula (I) (Riedl at page 3) as a crystalline salt. Riedl teaches that the salt can be acetate or L-lactate (Riedl at page 11), Riedl further specifies that the acid can be an organic acid or an inorganic acid and provides additional examples of acids.
Regarding instant claim 10-11, Brown teaches pleuromutilin derivatives in pharmaceutically acceptable carries used to treat microbial infections. Brown teaches pharmaceutically acceptable acid-addition salts include citrate, acetate and lactate (Brown at page lines 26-35). Kapsner recites a composition which may include BC-3781(Kapsner at claim 5) and a carriers, diluents or adjuvants (Kapsner at claim 13). Kapsner further teaches that each of antibacterial compounds may be salts, solvates or hydrates and more specifically salts of citric, lactic, or acetic acid (Kapsner at page 42). Riedl teaches the structure of instantly clamed Formula (I) (Riedl at page 3) as a crystalline salt.
Regarding instant claim 15, Brown specifies that injectable forms have a pH of from 3 to 9 (Brown at page 20 line 30 - page 21 line 13) which overlaps the instantly claimed pH range of 2 to 6. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 16, Brown specifies that injectable forms have a pH of from 3 to 9 (Brown at page 20 line 30 - page 21 line 13) which overlaps the instantly claimed pH range of 3 to 5.5. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 17, Brown specifies that injectable forms have a pH of from 3 to 9 (Brown at page 20 line 30 - page 21 line 13) which overlaps the instantly claimed pH range of 4 to 5. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 18, Brown specifies that injectable forms have a pH of from 3 to 9 (Brown at page 20 line 30 - page 21 line 13) which overlaps the instantly claimed value of 5. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 21, Kapsner specifies that for liquid compositions water, aqueous saline, aqueous dextrose or phosphate buffered saline (pH 7-8) would be acceptable excipients (Kapsner at pages 44-45). Riedl teaches that the salts can be used for intravenous applications, i.e. injection (Riedl at page 12), and more specifically that the solubility of the salts in water and aqueous based vehicles such as 0.9% NaCl solution or biorelevant media like FaSSIF and FeSSIF was high making the salts more pharmaceutically viable (Riedl at page 12).
C) Claims 1-12 and 15-25 are rejected under 35 U.S.C. 103 as being unpatentable over Riedl (WO 2011/146954 A1) and Kapsner (WO 2014/191109 A1) and Brown (WO 2004/089886) in view of Berdini (WO 2006/070195 A1).
The teachings of Riedl, Kapsner, and Brown are discussed above.
The teachings of Riedl, Kapsner, and Brown collectively fail to disclose the specific buffers used to control the pH of the composition. The teachings of Berdini cure this deficit.
Berdini teaches different methods and reagents for producing salts (Berdini at pages 44-48) and disclose a list of advantages for using salts (Berdini at page 46). Further teaches a preference for lactate and citrate salts for their advantages including
-will be more soluble in particular they will have improved solubility in aqueous solution and hence will be better for i.v. administration (e.g. by infusion)
- will allow control of solution pH and are therefore better for i.v. administration;
- may have improved anti-cancer activity; and
- may have an improved therapeutic index.
- will have better stability for example thermal stability (e.g. improved shelf life);
- will have advantages for production; and
- will have better physiochemical properties,
(Berdini at page 58) and further lay out their preferred pH range of 2 to 6 and that they may include buffers (Berdini at page 65) with a preference for citric acid as the buffer (Berdini at page 66). Further teaches that for pharmaceutical injections the acceptable pH range is 2-12 for intravenous administration and that the pH of these solutions is controlled by the salt form of the drug and buffers including citrate and phosphate (Berdini at pages 113-114).
Berdini does not teach instant formula I.
It would have been prima facie obvious to one of ordinary skill in the art to have selected citrate as a buffer for the composition of Riedl as citrate is known in the art as a common buffering agent see MPEP §2144.07 and is taught as a buffering agent for intravenous composition in Berdini. One of ordinary skill in the art would have the prerequisite skill and knowledge to buffer a composition and optimize the type of buffer, the strength of the buffer solution, and the amount of buffer used to the desired end pH of the composition.
Regarding instant claims 6-8, Kapsner and Brown teach the use of citric acid to buffer the composition as a salt. Kapsner and Brown further teach the use of a buffer in the composition. Berdini teaches the use of buffers in intravenous compositions and more specially the use of citrate to optimize the pH of the solution. One of ordinary skill in the art would know to optimize the molarity or strength of the citric acid. This would be considered routine optimization because the amount of acid added would variable based on the strength of the acid. See MPEP § 2144.05(II). Likewise, Riedl and Kapsner teach a pharmaceutically effective amount of the composition which would be optimized based on the concentration of formulation within the fluid. This would be considered routine optimization because the dose of end composition injected would variable based on the concentration of the formula within the composition and the dose required by the subject. See MPEP § 2144.05(II). Regarding the pH of the composition Brown further specifies that injectable forms have a pH of from 3 to 9 (Brown at page 20 line 30 - page 21 line 13) which overlaps with the instantly claimed pH range of 3 to 5.5. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claims 19-20, Kapsner and Brown teach the use of citric acid to buffer the composition as a salt. Kapsner and Brown further teach the use of a buffer in the composition. Berdini teaches the use of buffers in intravenous compositions and more specially the use of citrate to optimize the pH of the solution. One of ordinary skill in the art would know to optimize the molarity or strength of the citric acid. This would be considered routine optimization because the amount of acid added would variable based on the strength of the acid. See MPEP § 2144.05(II).
Regarding instant claims 22-24, Brown specifies that injectable forms have a pH of from 3 to 9 (Brown at page 20 line 30 - page 21 line 13) which overlaps the instantly claimed value of 5. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
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.
I) Claims 1-12 and 15-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12, 121,582 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent requires a pH of from 4 to 6 which is not required in the independent claim of the instant application. The instant application recites an injectable pharmaceutical formulation comprising a compound of formula (I)
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said formulation being buffered to a pharmaceutically acceptable pH-value.
The reference patent recites an injectable pharmaceutical formulation comprising a compound of formula (I)
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or a pharmaceutically acceptable salt thereof, said formulation being buffered to a pharmaceutically acceptable pH-value of from 4 to 6, wherein the buffer is a citrate buffer
(‘582 at claim 1). The reference patent recites wherein the buffered formulation comprises a pharmaceutically acceptable vehicle (‘582 at claim 2). The reference patent recites wherein the citrate buffer is 10 mM to 20 mM, the pH-value of the formulation is from 4 to 5.5, the concentration of the compound of formula (I) is between 0.2 to 3 mg/ml (calculated as free base form), and the formulation comprises a pharmaceutically acceptable vehicle (‘582 at claim 3). The reference patent recites wherein the citrate buffer is 10 mM and the concentration of the compound of formula (I) is between 0.3 to 1.2 mg/ml (‘582 at claim 4). The reference patent recites wherein the concentration of the compound of formula (I) is between 0.3 to 0.6 mg/ml (‘582 at claim 5). The reference patent recites wherein the compound of formula (I) is employed as a pharmaceutically acceptable salt (‘582 at claim 6). The reference patent recites a method of treating diseases mediated by microbes comprising administering the formulation according to claim 1 to a subject in need of said treatment (‘582 at claim 7). The reference patent recites wherein the formulation is administered via intravenous application (‘582 at claim 8). The reference patent recites a pharmaceutical composition, comprising an injectable formulation comprising a compound of formula (I),
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or a pharmaceutically acceptable salt thereof, said formulation being buffered to a pharmaceutically acceptable pH-value of from 4 to 5.5, wherein the buffer is a citrate buffer
(‘582 at claim 9). The reference patent recites wherein the pharmaceutically acceptable pH-value is from 4 to 5.5 (‘582 at claim 10). The reference patent recites wherein the pharmaceutically acceptable pH-value is from 4 to 5 (‘582 at claim 11). The reference patent recites wherein the pharmaceutically acceptable pH-value is about 5 (‘582 at claim 12). The reference patent recites wherein the citrate buffer is a 10 to 20 mM citrate buffer (‘582 at claim 13). The reference patent recites wherein the citrate buffer is a 10 mM citrate buffer (‘582 at claim 14). The reference patent recites wherein the pharmaceutically acceptable vehicle is selected from the group consisting of normal saline solution, 5% dextrose solution and mixtures thereof (‘582 at claim 15). The reference patent recites wherein the pH-value of the formulation is 5 (‘582 at claim 16). The reference patent recites wherein the pharmaceutically acceptable salt is selected from the group consisting of acetate and L-lactate (‘582 at claim 17).
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
II) Claims 1-12 and 15-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-6 and 21-23 of copending Application No.18/837,088 (reference application) in view of Riedl (WO 2011/146954 A1), Kapsner (WO 2014/191109 A1), Brown (WO 2004/089886), and Berdini (WO 2006/070195 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application does not require the composition to be injectable. The instant application recites an injectable pharmaceutical formulation comprising a compound of formula (I)
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said formulation being buffered to a pharmaceutically acceptable pH-value.
The reference application recites wherein the compound or the pharmaceutically acceptable salt, solvate, prodrug or metabolite thereof is Lefamulin or its pharmaceutically acceptable salts, solvates, prodrugs or metabolites (‘088 at claim 4). The reference application recites wherein the compound or the pharmaceutically acceptable salt, solvate, prodrug or metabolite thereof is in the form of a salt and/or a solvate (‘088 at claim 5). The reference application recites wherein the compound or the pharmaceutically acceptable salt, solvate, prodrug or metabolite thereof is Lefamulin in the form of Lefamulin acetate salt (‘088 at claim 6). The reference application recites wherein the compound or the pharmaceutically acceptable salt, solvate, prodrug or metabolite thereof is administered as a formulation for oral administration comprising about 600 mg of lefamulin or about 600 mg of lefamulin in the form of a pharmaceutically acceptable salt, solvate, or prodrug thereof, optionally wherein the formulation is in the form of a tablet or a capsule (‘088 at claim 21). The reference application recites wherein the compound or the pharmaceutically acceptable salt, solvate, prodrug or metabolite thereof is administered as a formulation for oraladministration comprising about 600 mg of lefamulin or about 600 mg of lefamulin in the form of a pharmaceutically acceptable salt, solvate, or prodrug thereof, optionally wherein the formulation is in the form of a tablet or a capsule (‘088 at claim 22). The reference application recites wherein the compound or the pharmaceutically acceptable salt, solvate, prodrug or metabolite thereof is administered as a formulation for oral administration comprising about 600 mg of lefamulin or about 600 mg of lefamulin in the form of a pharmaceutically acceptable salt, solvate, or prodrug thereof, optionally wherein the formulation is in the form of a tablet or a capsule (‘088 at claim 23).
The reference application differs from the instant application insofar as it is not specific with the components of its Lefamulin injection. The teachings of Riedl (WO 2011/146954 A1), Kapsner (WO 2014/191109 A1), Brown (WO 2004/089886), and Berdini (WO 2006/070195 A1) cure this deficit.
The teachings of Riedl (WO 2011/146954 A1), Kapsner (WO 2014/191109 A1), Brown (WO 2004/089886), and Berdini (WO 2006/070195 A1) are discussed above.
It would be prima facie obvious to one of ordinary skill in the art to have formulated the Lefamulin in the method of ‘088 by the teachings of Riedl (WO 2011/146954 A1), Kapsner (WO 2014/191109 A1), Brown (WO 2004/089886), and Berdini (WO 2006/070195 A1) which teach injectable forms of Lefamulin. One would have a reasonable expectation of success because Riedl (WO 2011/146954 A1), Kapsner (WO 2014/191109 A1), Brown (WO 2004/089886), and Berdini (WO 2006/070195 A1) teach injectable Lefamulin.See MPEP 2144.07. See MPEP 2144.06(I).
Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
III) Claim 1-12 and 15 -25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34 and 54-73 of copending Application No. 17/919,200 (reference application) in view of Riedl (WO 2011/146954 A1), Kapsner (WO 2014/191109 A1), Brown (WO 2004/089886), and Berdini (WO 2006/070195 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application does not require the use of a buffer. The instant application recites an injectable pharmaceutical formulation comprising a compound of formula (I)
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said formulation being buffered to a pharmaceutically acceptable pH-value.
The reference application recites lefamulin in the form of an acid addition salt with itaconic acid, optionally lefamulin itaconate (‘200 at claim 34). The reference application recites a method of treating or preventing an inflammatory disease characterized by neutrophilic inflammation, the method comprising administering to a subject in need thereof lefamulin or a pharmaceutically acceptable salt, solvate, or prodrug thereof (‘200 at claim 56). The reference application recites wherein the lefamulin or pharmaceutically acceptable salt, solvate, or prodrug thereof is administered by injection (‘200 at claim 61).
The reference application differs from the instant application insofar as it is not specific with the components of its Lefamulin injection. The teachings of Riedl (WO 2011/146954 A1), Kapsner (WO 2014/191109 A1), Brown (WO 2004/089886), and Berdini (WO 2006/070195 A1) cure this deficit.
The teachings of Riedl (WO 2011/146954 A1), Kapsner (WO 2014/191109 A1), Brown (WO 2004/089886), and Berdini (WO 2006/070195 A1) are discussed above.
It would be prima facie obvious to one of ordinary skill in the art to have formulated the Lefamulin in the composition and method of ‘200 by the teachings of Riedl (WO 2011/146954 A1), Kapsner (WO 2014/191109 A1), Brown (WO 2004/089886), and Berdini (WO 2006/070195 A1) which teach injectable forms of Lefamulin. One would have a reasonable expectation of success because Riedl (WO 2011/146954 A1), Kapsner (WO 2014/191109 A1), Brown (WO 2004/089886), and Berdini (WO 2006/070195 A1) teach injectable Lefamulin.See MPEP 2144.07. See MPEP 2144.06(I).
Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are presently allowable.
Correspondence
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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