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 without traverse of Group I (i.e., claims 1-17 drawn to an aqueous dalbavancin formulation) in the reply filed on 5/29/26 is acknowledged. Additionally, Applicant’s election without traverse of Species A (i.e., a single and specific aqueous formulation as a formulation comprising dalbavancin in a concentration of 1 mg/ml to 7 mg/ml as a single and specific concentration range of dalbavancin, a molar ratio of dalbavancin to hydroxypropyl beta cyclodextrin of 1:0.6 to 1:2 as a single and specific molar ratio of dalbavancin to hydroxypropyl beta cyclodextrin, and dextrose as an additional excipient and/or additive) in the reply filed on 5/29/26 is acknowledged. It is noted that Species B is not elected as it pertains to Group II, which has not been elected.
Please note that Species A is expanded to include the concentration and ratio limitations of instant claims 5-8 and 15-16.
Status of Claims
Claims 1-19 were originally filed on July 12, 2024.
Claims 1-19 are currently pending and claims 1-17 are under consideration as claims 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Election was made without traverse in the reply filed on May 29, 2026.
Priority
The present application is a continuation of 18/484,819, filed October 11, 2023, now issued as US Patent No. 12,070,485 B2, which claims the benefit under 35 U.S.C. 119(e) to U.S. Provisional Application No. 63/518,014 filed August 7, 2023. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
The present application also claims priority under 119(a)-(d) to European Application No. 23157323.9 filed on February 17, 2023, and to Danish Application No. PA202200932 filed October 12, 2022. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d) for European Application No. 23157323.9 and for Danish Application No. PA202200932, which papers have been placed of record in the file. Please note both the European and Danish applications are in English, and therefore, no further action is needed.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on July 12, 2024 (2 IDSs); and June 30, 2026, are being considered by the examiner.
Claim Objections
Claims 9-13 are objected to because of the following informalities: the claims recite, “… as measured by HPLC.” Although, the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The Examiner respectfully requests that Applicant uses high performance liquid chromatography (HPLC) for the first recitation, thereafter HPLC may be utilized. 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 2 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 2 recites the limitation "the solution" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is noted that claim 2 is dependent upon claim 1, which only refers to an aqueous formulation and not a solution.
Claims 11-13 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. In the preamble each of claims 11-13 recite, “[t]he aqueous formulation according to any one of claim 10,…” (emphasis added). As such, the dependency of each claim is unclear because only one claim is recited, i.e., claim 10, but the claim language implies that each claim is dependent upon more than one claim, i.e., any one of. Therefore, an ordinary skilled artisan would be unable to ascertain the metes and bounds of the presently claimed invention with respect to the dependency of each of claims 11-13.
Please note that the Examiner is interpreting the scope of each claim such that it is dependent upon claim 10 in order to further prosecution.
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 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 pre-AIA 35 U.S.C. 103(a) 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
103 - KSR Examples of 'Rationales' Supporting a Conclusion of Obviousness(Consistent with the "Functional Approach" of Graham)
Further regarding 35 USC 103(a) rejections, the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) (KSR) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Also, a reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976).
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Keser et al. WO 2017/194385 A1 published November 16, 2017 (cited in the IDS received on 7/12/24) in view of Stella et al., Toxicologic Pathol. 36:30-42 (2008) (cited in the IDS received on 7/12/24).
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
For claims 1-3, with respect to an aqueous formulation comprising dalbavancin or a pharmaceutically acceptable salt thereof and a cyclodextrin as recited in instant claim 1; with respect to where the formulation is an aqueous sterile solution as recited in instant claim 2; and with respect to where the formulation is an aqueous sterile formulation as recited in instant claim 3:
Keser et al. teaches a liquid pharmaceutical composition comprising a glycopeptide antibiotic and sulfobutylether-beta cyclodextrin where the pharmaceutical composition is stable for at least about four weeks (1 month) at 25 degrees Celsius in a closed container (See Keser specification, pg. 5, 6th paragraph; pg. 14, last paragraph; pg. 16, 5th paragraph). The glycopeptide antibiotic is selected from Vancomycin, Telavancin, Oritavancin, Teicoplanin and Dalbavancin (See Keser specification, pg. 5, last paragraph; pg. 14, last paragraph). The inclusion of the sulfobutylether-beta cyclodextrin in the pharmaceutical composition stabilizes the glycopeptide antibiotic for at least about 4 weeks at 25 degrees Celsius in a closed container (See Keser specification, pg. 6, 4th paragraph) such that the liquid and pre-mixed ready-to-use, injectable formulations are chemically and physically stable at room temperature (See Keser specification, pg. 8, 2nd paragraph). Keser et al. defines a cyclodextrin as including the partially and completely substituted cyclodextrins such as sulfobutylether beta cyclodextrin (SBEβ-CD) (See Keser specification, pg. 10, 5th-6th paragraph). As such, the teachings of Keser et al. satisfy the claim limitations with respect to a formulation comprising dalbavancin and a cyclodextrin as recited in instant claim 1.
Moreover, Keser et al. defines an aqueous composition as any solution in which water is the only solvent or one of the main solvents (equal or above 50% V/V) (See Keser specification, pg. 12, 4th paragraph). A liquid composition or solution is meant to embrace any liquid form of a formulation no matter if the solvent is one or a mixture of two or more solvents in any suitable concentration where the solvent(s) can be water, sterile water, and/or bacteriostatic water for injection (See Keser specification, pg. 12, last paragraph to pg. 13, 1st paragraph). A liquid composition comprising vancomycin HCl is meant to cover solutions made by dissolving vancomycin HCl or by addition of equimolar amounts of HCl to vancomycin base (See Keser specification, pg. 13, 3rd paragraph). Keser et al. also teaches that the terms: pharmaceutical compositions, pharmaceutical formulations, liquid compositions, liquid formulations, compositions, formulations, and solutions are interchangeable (See Keser specification, pg. 13, 4th paragraph). Sterile is defined as a composition that has been brought to a state of sterility and has not been subsequently exposed to microbiological contamination (See Keser specification, pg. 14, 8th paragraph). Thus when considering the teachings of Keser et al. as a whole, the liquid formulation encompasses an aqueous sterile formulation or solution thereby suggestive of the claim limitations as recited in instant claims 1-3.
For claim 1, with respect to where the cyclodextrin is hydroxypropyl beta cyclodextrin:
As discussed supra, Keser et al. defines a cyclodextrin as including the partially and completely substituted cyclodextrins (See Keser specification, pg. 10, 5th-6th paragraph). Keser et al. teaches that a cyclodextrin such as sulfobutylether-beta cyclodextrin (SBEβ-CD) stabilizes a glycopeptide antibiotic such as dalbavancin. However, Keser et al. does not expressly teach that the cyclodextrin is hydroxypropyl beta cyclodextrin.
Stella et al. teaches that beta cyclodextrins (β-CD) and other cyclodextrins (CDs) have utility for solubilizing and stabilizing drugs; however, some are nephrotoxic when administered parenterally (See Stella article, abstract). Stella et al. teaches that both SBE-β-CD (sulfobutylether β-CD) is a non-nephrotoxic derivative and HP-β-CD (hydroxypropyl-β-CD) have undergone extensive safety studies and are currently used in six products approved by the FDA (See Stella article, abstract). Complexes between the two derivatives and various drugs have been shown to rapidly dissociate after parenteral drug administration, to have no tissue-irritating effects after intramuscular dosing, and to result in superior oral bioavailability of poorly water-soluble drugs (See Stella article, abstract). Stella et al. found that both derivatives are well tolerated in humans and have no adverse effects on the kidneys or other organs following either oral or IV administration (See Stella article, abstract). Therefore, the teachings of Stella et al. demonstrate that both SBE-β-CD and HP-β-CD exhibit similar pharmacokinetic properties and used to solubilize and stabilize poorly water-soluble drugs. Thus, an ordinary skilled artisan would substitute the SBE-β-CD taught by Keser et al. with HP-β-CD with the expectation that the HP-β-CD would exhibit similar stabilizing effect on a glyopeptide antibiotic such as dalbavancin as further articulated below.
For claims 1 and 4-8, with respect to where the concentration of dalbavancin is 1 mg/ml to 25 mg/ml as recited in instant claim 1; with respect to where the concentration of dalbavancin is 1 mg/ml to 7 mg/ml as recited in instant claim 4; with respect to where the concentration of dalbavancin is 15 mg/ml to 22 mg/ml as recited in instant claim 5; with respect to where the concentration of dalbavancin is 2 mg/ml to 6 mg/ml as recited in instant claim 6; with respect to where the concentration of dalbavancin is 4 mg/ml to 6 mg/ml as recited in instant claim 7; and with respect to where the concentration of dalbavancin is 18 mg/ml to 22 mg/ml as recited in instant claim 8:
As discussed supra, the glycopeptide antibiotic is selected from Vancomycin, Telavancin, Oritavancin, Teicoplanin and Dalbavancin (See Keser specification, pg. 5, last paragraph; pg. 14, last paragraph). Keser et al. exemplifies vancomycin as the glycopeptide antibiotic (See Keser specification, pg. 5, 8th paragraph; pg. 36, 7th paragraph). Keser et al. also teaches that the concentration of vancomycin ranges from about 0.1% w/V to about 15% w/V (See Keser specification, pg. 17, 5th paragraph; pg. 20, 4th paragraph; pg. 33, 6th paragraph; pg. 36, 8th paragraph; pg. 50, 2nd paragraph) thereby equating to a concentration range of about 1 mg/ml to about 150 mg/ml (i.e., 0.1% w/V = 0.1g/100 ml x 1ml = 0.001 g x 1000 = 1 mg, which then constitutes 1 mg per ml of fluid; and 15% w/V = 15g/100 ml x 1ml = 0.15 g x 1000 = 150 mg, which then constitutes 150 mg per ml of fluid). Specific concentrations of the glycopeptide antibiotics include 0.5% w/V (i.e., 5 mg/ml), 5% w/V (i.e., 50 mg/ml), and 10% w/V (i.e., 100 mg/ml) (See Keser specification, pg. 33, 7th paragraph; pg. 36, 9th paragraph; pg. 50, 2nd paragraph). As such, the concentration range taught by Keser et al. would be applicable to each of the five glycopeptide antibiotics, especially given that there are a small finite number of glycopeptide species taught by Keser et al., without evidence to the contrary. Therefore, the claimed concentration ranges of dalbavancin lie within the glycopeptide antibiotic concentration taught by Keser et al. as further articulated below.
For claims 1 and 14-16, with respect to where the molar ratio of dalbavancin to hydroxypropyl beta cyclodextrin is 1:0.5 to 1:2 as recited in instant claim 1; with respect to where the molar ratio of dalbavancin to hydroxypropyl beta cyclodextrin is 1:0.6 to 1:2 as recited in instant claim 14; with respect to where the molar ratio of dalbavancin to hydroxypropyl beta cyclodextrin is 1:0.6 to 1:1 as recited in instant claim 15; and with respect to where the molar ratio of dalbavancin to hydroxypropyl beta cyclodextrin is 1:0.7 to 1:0.9 as recited in instant claim 16:
As discussed supra, the glycopeptide antibiotic is selected from Vancomycin, Telavancin, Oritavancin, Teicoplanin and Dalbavancin (See Keser specification, pg. 5, last paragraph; pg. 14, last paragraph). Keser et al. exemplifies vancomycin as the glycopeptide antibiotic (See Keser specification, ). Keser et al. also teaches that a molar ratio of vancomycin to SBEβ-CD ranges from about 1:0.5 to about 1:40, or from about 1:0.5 to about 1:5 (See Keser specification, pg. 17, last paragraph to pg. 18, 1st paragraph; pg. 18, 3rd paragraph). As such, the molar ratio range taught by Keser et al. would be applicable to each of the five glycopeptide antibiotics, especially given that there are a small finite number of glycopeptide species taught by Keser et al., without evidence to the contrary. Therefore, the instantly claimed molar ratio ranges lie within the molar ratio ranges taught by Keser et al. as further articulated below.
For claim 1, with respect to where the pH in the formulation is 3.5 to 4.5:
Keser et al. teaches that the preferred pH range for the formulation is from about 2.0 to about 6.0, in particular from about 2.5 to about 5.5, and specifically from about 4.5 to about 5.5 (See Keser specification, pg. 11, last paragraph; pg. 16, 4th paragraph). Thus, the instantly claimed pH range lies with the pH range taught by Keser et al. as further articulated below.
For claim 2, with respect to where the formulation is for parenteral administration:
Keser et al. teaches that the pharmaceutical compositions can be administered by parenteral routes, well known in the prior art (See Keser specification, pg. 16, 7th paragraph). Thus, the teachings of Keser et al. satisfy the claim limitation with respect to where the formulation is for parenteral administration as recited in instant claim 2.
However, although Keser et al. does teach that the formulation can be administered parenterally, the Examiner would like to remind Applicants that the preamble recites an aqueous formulation, and while the use of a descriptive clause, i.e. “for parenteral administration," when referring to the contemplated use (i.e. “intended use”) of a claimed compound is proper, it is not a limitation and thus of no significance in determining the patentability thereof over the prior art, please refer to In re Thomas (CCPA 1949) 178 F2d 412, 84 USPQ 132. Therefore, the teachings of Keser et al. satisfy the claim limitation with respect to where the formulation is for parenteral administration as recited in instant claim 2.
For claims 9-13, with respect to where the formulation has less than an 8% increase of mannosyl aglycon impurity after storage at room temperature for 3 months as measured by HPLC as recited in instant claim 9; with respect to where the formulation has less than an 2% increase of mannosyl aglycon impurity after storage at room temperature for 3 months as measured by HPLC as recited in instant claim 10; with respect to where the formulation has less than a 1.5% increase of mannosyl aglycon impurity after storage at room temperature for 3 months as measured by HPLC as recited in instant claim 11; with respect to where the formulation has less than a 1.0% increase of mannosyl aglycon impurity after storage at room temperature for 3 months as measured by HPLC as recited in instant claim 12; and with respect to where the formulation has less than a 0.8% increase of mannosyl aglycon impurity after storage at room temperature for 3 months as measured by HPLC as recited in instant claim 13:
As discussed supra for claim 1, Keser et al. teaches a liquid pharmaceutical composition comprising a glycopeptide antibiotic and sulfobutylether-beta cyclodextrin where the pharmaceutical composition is stable for at least about four weeks (1 month) at 25 degrees Celsius in a closed container (See Keser specification, pg. 5, 6th paragraph; pg. 14, last paragraph; pg. 16, 5th paragraph). The glycopeptide antibiotic is selected from Vancomycin, Telavancin, Oritavancin, Teicoplanin and Dalbavancin (See Keser specification, pg. 5, last paragraph; pg. 14, last paragraph). The inclusion of the sulfobutylether-beta cyclodextrin in the pharmaceutical composition stabilizes the glycopeptide antibiotic for at least about 4 weeks at 25 degrees Celsius in a closed container (See Keser specification, pg. 6, 4th paragraph) such that the liquid and pre-mixed ready-to-use, injectable formulations are chemically and physically stable at room temperature (See Keser specification, pg. 8, 2nd paragraph) thereby constituting a time frame that overlaps with the instantly claimed timeframe of 3 months as recited in instant claims 9-13. Keser et al. also teaches that the stable liquid pharmaceutical formulations of glycopeptide antibiotics show chemical and physical stability when stored at temperatures from 2 degrees Celsius to 30 degrees Celsius (See Keser specification, pg. 15, 4th paragraph) thereby encompassing room temperature (i.e., about 20 degrees Celsius). Keser et al. further teaches that when stored at 25 degrees Celsius (which is close to room temperature), the pharmaceutical compositions exhibit between 0% to about 15% loss of the initial purity of the drug and between 0% and to about 10% of two main impurities CDP-1 and DAMS formation independently (See Keser specification, pg. 15, last paragraph to pg. 16, 1st paragraph).
However, Keser et al. does not expressly determine the percentage of mannosyl aglycon (MAG) impurity after storage at room temperature for 3 months as measured by HPLC. MPEP 2112-2112.02 states that when a reference discloses all the limitations of a claim except for a property or function, and the examiner cannot determine whether or not the reference inherently possesses properties which render obvious the claimed invention but has basis for shifting the burden of proof to applicant as in In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980). In the instant case, as discussed supra, Keser et al. teaches that the liquid formulations comprising a glycopeptide and a cyclodextrin such as SBE-β CD is physically and chemically stable for at least 1 month at a temperature of 25 degrees Celsius such that 0% to about 10% of two main impurities CDP-1 and DAMS formation is present.
The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not applicants’ aqueous formulation differs, and if so to what extent, from the liquid formulation taught in Keser et al. The cited art taken as a whole demonstrates a reasonable probability that the liquid formulation of Keser et al. is either identical or sufficiently similar to the claimed aqueous formulation that whatever differences exist are not patentably significant. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Merely because a function of a liquid formulation is not expressly taught in a reference does not make the known formulation patentable. The new aqueous formulation possesses inherent functions which might not be displayed in the tests used in Keser et al. Accordingly, the teachings of Keser et al. is a sufficient basis that the liquid formulation contains less than 8%, 2%, 1.5%, 1.0% and 0.8% of MAG impurity after storage at room temperature for 3 months as measured by HPLC.
In the alternative, even if the claimed aqueous formulation is not identical to the Keser liquid formulation with regard to some unidentified functions, the differences between that which is disclosed and that which is claimed are considered to be so slight that the Keser liquid formulation is likely to necessarily possess the same functions of the claimed aqueous formulation particularly in view of the similar characteristics which they have been shown to share (i.e., being physically and chemically stable for at least 1 month at a temperature of 25 degrees Celsius having 0% to about 10% of two main impurities CDP-1 and DAMS). Thus, the claimed aqueous formulation would have been obvious to those of ordinary skill in the art under the meaning of USC 103. Accordingly, the claimed invention as a whole was at least prima facie obvious, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
For claim 17, with respect to where the formulation further comprises dextrose:
Keser et al. teaches that the liquid formulation can further comprise one or more diluents (See Keser specification, pg. 19, 4th paragraph). The diluents are selected from sterile water, bacteriostatic water for injection, a pH buffered solution, saline solution, Ringer’s solution, dextrose solution, Normosol®-M and ISOLYTE® E (See Keser specification, pg. 19, 4th paragraph). Given the finite number of diluents, an ordinary skilled artisan would be motivated to utilize a combination of sterile water/bacteriostatic water with dextrose solution in the liquid formulation as further articulated below. Thus, the teachings of Keser et al. are suggestive of the claim limitation as recited in instant claim 17.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims (MPEP §2141.012)
Keser et al. does not expressly teach a specific embodiment of an aqueous formulation comprising dalbavancin and hydroxypropyl beta cyclodextrin where the concentration of dalbavancin is 1 mg/ml to 25 mg/ml, the molar ratio of dalbavancin to hydropropyl beta cyclodextrin is 1:0.5 to 1:2, the pH in the formulation is 3.5 to 4.5, and where the formulation does not comprise a buffer as recited in instant claim 1. However, the teachings of Keser et al. and Stella et al. cure these deficiencies by constituting the simple substitution of one known element for another to obtain predictable results and/or some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention and/or the use of known technique to improve similar devices (methods, or products) in the same way and/or the application of a known technique to a known device (method, or product) ready for improvement to yield predictable results pursuant to KSR. Additionally, the claimed concentration, molar ratio and pH ranges lie within the concentration, molar ratio and pH ranges taught by Keser et al. as further articulated below.
Keser et al. does not expressly teach where the formulation is an aqueous sterile solution or formulation as recited in instant claims 2-3. However, the teachings of Keser et al. cure this deficiency by constituting the simple substitution of one known element for another to obtain predictable results and/or some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention and/or the use of known technique to improve similar devices (methods, or products) in the same way and/or the application of a known technique to a known device (method, or product) ready for improvement to yield predictable results pursuant to KSR.
Keser et al. does not expressly teach a specific embodiment where the concentration of dalbavancin is 1 mg/ml to 7 mg/ml as recited in instant claim 4, where the concentration of dalbavancin is 15 mg/ml to 22 mg/ml as recited in instant claim 5, where the concentration of dalbavancin is 2 mg/ml to 6 mg/ml as recited in instant claim 6, where the concentration of dalbavancin is 4 mg/ml to 6 mg/ml as recited in instant claim 7, and where the concentration of dalbavancin is 18 mg/ml to 22 mg/ml as recited in instant claim 8. However, the claimed concentration ranges lie within the concentration range taught by Keser et al. as further articulated below.
Keser et al. does not expressly teach a specific embodiment where the molar ratio of dalbavancin to hydroxypropyl beta cyclodextrin is 1:0.6 to 1:2 as recited in instant claim 14, where the molar ratio of dalbavancin to hydroxypropyl beta cyclodextrin is 1:0.6 to 1:1 as recited in instant claim 15, and where the molar ratio of dalbavancin to hydroxypropyl beta cyclodextrin is 1:0.7 to 1:0.9 as recited in instant claim 16. However, the claimed molar ratio ranges lie within the molar ratio range taught by Keser et al. as further articulated below.
Keser et al. does not expressly teach where the formulation further comprises dextrose as recited in instant claim 17. However, the teachings of Keser et al. cure this deficiency by constituting the simple substitution of one known element for another to obtain predictable results and/or some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention and/or the use of known technique to improve similar devices (methods, or products) in the same way and/or the application of a known technique to a known device (method, or product) ready for improvement to yield predictable results pursuant to KSR.
Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-4143)
With respect to a specific embodiment of an aqueous formulation comprising dalbavancin and hydroxypropyl beta cyclodextrin where the concentration of dalbavancin is 1 mg/ml to 25 mg/ml, the molar ratio of dalbavancin to hydropropyl beta cyclodextrin is 1:0.5 to 1:2, the pH in the formulation is 3.5 to 4.5, and where the formulation does not comprise a buffer as recited in instant claim 1, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to modify the teachings of Keser et al. and formulate dalbavancin as a glycopeptide antibiotic in a concentration ranging from 1 mg/ml to 150 mg/ml with HP-β-CD as a cyclodextrin instead of SBE-β-CD and water as a solvent without the need of a buffer where the molar ratio of dalbavancin to HP-β-CD ranges from about 1:0.5 to about 1:5 and where the pH of the formulation ranges from 2.0 to 6.0 thereby resulting in the rapid dissociation of HP-β-CD after parenteral drug administration, no tissue-irritating effects after intramuscular dosing, no nephrotoxicity, and in superior oral bioavailability of dalbavancin, and such that the inclusion of the cyclodextrin stabilizes the glycopeptide antibiotic for at least about four weeks (1 month) at 25 degrees Celsius in a closed container. One of ordinary skill in the art at the time the invention was made would have been motivated to do so because both SBE-β-CD and HP-β-CD were known to exhibit similar pharmacokinetic properties and used to solubilize and stabilize poorly water-soluble drugs with no nephrotoxic effects as taught by Stella et al.
One of ordinary skill in the art at the time the invention was made would have had a reasonable expectation of success given that the formulation of Keser et al. comprises a glycopeptide antibiotic in a concentration ranging from 1 mg/ml to 150 mg/ml, a cyclodextrin such as SBE-β-CD, and a solvent such as water without the need of a buffer where the molar ratio of the glycopeptide antibiotic to HP-β-CD ranges from about 1:0.5 to about 1:5 and where the pH of the formulation ranges from 2.0 to 6.0 such that the inclusion of the cyclodextrin stabilizes the glycopeptide antibiotic for at least about four weeks (1 month) at 25 degrees Celsius in a closed container. Therefore, substituting HP-β-CD instead of SBE-β-CD as the cyclodextrin and substituting dalbavancin as the glycopeptide antibiotic would support the stabilization of dalbavancin antibiotic for at least about four weeks (1 month) at 25 degrees Celsius in a closed container, the rapid dissociation of HP-β-CD after parenteral drug administration, no tissue-irritating effects after intramuscular dosing, no nephrotoxicity, and superior oral bioavailability of dalbavancin by constituting the simple substitution of one known element for another to obtain predictable results and/or some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention and/or the use of known technique to improve similar devices (methods, or products) in the same way and/or the application of a known technique to a known device (method, or product) ready for improvement to yield predictable results pursuant to KSR.
Additionally, regarding the concentration of dalbavancin, MPEP 2144.05(I) states that "[i]n the case where the claimed ranges "overlap or lie inside ranges discloses 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) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%". The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.) Moreover, the Federal Circuit found that a prima facie case existed where a claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms and the prior art taught that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." In re Geisler, 116 F.3d 1465, 1469-82, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). Therefore, the claimed concentration range of dalbavancin would have been obvious to one of ordinary skill in the art since the claimed range (i.e., 1 mg/mL to 25 mg/mL as recited in instant claim 1) lies within the prior art concentration range of dalbavancin (i.e., 1 mg/mL to 150 mg/mL).
Regarding the molar ratio of dalbavancin to HP-β-CD, MPEP 2144.05(I) states that "[i]n the case where the claimed ranges "overlap or lie inside ranges discloses 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) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%". The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.) Moreover, the Federal Circuit found that a prima facie case existed where a claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms and the prior art taught that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." In re Geisler, 116 F.3d 1465, 1469-82, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). Therefore, the claimed molar ratio range of dalbavancin to HP-β-CD would have been obvious to one of ordinary skill in the art since the claimed range (i.e., 1:0.5 to 1:2 as recited in instant claim 1) lies within the prior art molar ratio range of dalbavancin to HP-β-CD (i.e., about 1:0.5 to about 1:5).
Regarding the pH, MPEP 2144.05(I) states that "[i]n the case where the claimed ranges "overlap or lie inside ranges discloses 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) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%". The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.) Moreover, the Federal Circuit found that a prima facie case existed where a claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms and the prior art taught that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." In re Geisler, 116 F.3d 1465, 1469-82, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). Therefore, the claimed pH range of the aqueous formulation would have been obvious to one of ordinary skill in the art since the claimed range (i.e., 3.5 to 4.5 as recited in instant claim 1) lies within the prior art pH range (i.e., 2.0 to 6.0).
With respect to where the formulation is an aqueous sterile solution or formulation as recited in instant claims 2-3, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to modify the teachings of Keser et al. and formulate dalbavancin as a glycopeptide antibiotic in a concentration ranging from 1 mg/ml to 150 mg/ml with HP-β-CD as a cyclodextrin instead of SBE-β-CD and sterile water as a solvent in the form of an aqueous sterile solution without the need of a buffer where the molar ratio of dalbavancin to HP-β-CD ranges from about 1:0.5 to about 1:5 and where the pH of the formulation ranges from 2.0 to 6.0 thereby resulting in the rapid dissociation of HP-β-CD after parenteral drug administration, no tissue-irritating effects after intramuscular dosing, no nephrotoxicity, and in superior oral bioavailability of dalbavancin, and such that the inclusion of the cyclodextrin stabilizes the glycopeptide antibiotic for at least about four weeks (1 month) at 25 degrees Celsius in a closed container. One of ordinary skill in the art at the time the invention was made would have been motivated to do so because both SBE-β-CD and HP-β-CD were known to exhibit similar pharmacokinetic properties and used to solubilize and stabilize poorly water-soluble drugs with no nephrotoxic effects as taught by Stella et al.; and because a liquid composition or solution was known to be defined as any liquid form of a formulation no matter if the solvent is one or a mixture of two or more solvents in any suitable concentration where the solvent(s) can be water, sterile water, and/or bacteriostatic water for injection as taught by Keser et al.
One of ordinary skill in the art at the time the invention was made would have had a reasonable expectation of success given that the formulation of Keser et al. comprises a glycopeptide antibiotic in a concentration ranging from 1 mg/ml to 150 mg/ml, a cyclodextrin such as SBE-β-CD, and one or more solvents without the need of a buffer where the molar ratio of the glycopeptide antibiotic to HP-β-CD ranges from about 1:0.5 to about 1:5 and where the pH of the formulation ranges from 2.0 to 6.0 such that the inclusion of the cyclodextrin stabilizes the glycopeptide antibiotic for at least about four weeks (1 month) at 25 degrees Celsius in a closed container. Therefore, substituting sterile water as the solvent, substituting HP-β-CD instead of SBE-β-CD as the cyclodextrin, and substituting dalbavancin as the glycopeptide antibiotic would support the stabilization of dalbavancin antibiotic for at least about four weeks (1 month) at 25 degrees Celsius in a closed container, the rapid dissociation of HP-β-CD after parenteral drug administration, no tissue-irritating effects after intramuscular dosing, no nephrotoxicity, and superior oral bioavailability of dalbavancin by constituting the simple substitution of one known element for another to obtain predictable results and/or some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention and/or the use of known technique to improve similar devices (methods, or products) in the same way and/or the application of a known technique to a known device (method, or product) ready for improvement to yield predictable results pursuant to KSR.
With respect to where the concentration of dalbavancin is 1 mg/ml to 7 mg/ml as recited in instant claim 4, where the concentration of dalbavancin is 15 mg/ml to 22 mg/ml as recited in instant claim 5, where the concentration of dalbavancin is 2 mg/ml to 6 mg/ml as recited in instant claim 6, where the concentration of dalbavancin is 4 mg/ml to 6 mg/ml as recited in instant claim 7, and where the concentration of dalbavancin is 18 mg/ml to 22 mg/ml as recited in instant claim 8, MPEP 2144.05(I) states that "[i]n the case where the claimed ranges "overlap or lie inside ranges discloses 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) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%". The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.) Moreover, the Federal Circuit found that a prima facie case existed where a claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms and the prior art taught that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." In re Geisler, 116 F.3d 1465, 1469-82, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). Therefore, the claimed concentration range of dalbavancin would have been obvious to one of ordinary skill in the art since the claimed range (i.e., 1 mg/mL to 7 mg/mL as recited in instant claim 4; 15 mg/mL to 22 mg/mL as recited in instant claim 5; 2 mg/mL to 6 mg/mL as recited in instant claim 6; 4 mg/mL to 6 mg/mL as recited in instant claim 7; and 18 mg/mL to 22 mg/mL as recited in instant claim 8) lies within the prior art concentration range of dalbavancin (i.e., 1 mg/mL to 150 mg/mL).
With respect to where the molar ratio of dalbavancin to hydroxypropyl beta cyclodextrin is 1:0.6 to 1:2 as recited in instant claim 14, where the molar ratio of dalbavancin to hydroxypropyl beta cyclodextrin is 1:0.6 to 1:1 as recited in instant claim 15, and where the molar ratio of dalbavancin to hydroxypropyl beta cyclodextrin is 1:0.7 to 1:0.9 as recited in instant claim 16, MPEP 2144.05(I) states that "[i]n the case where the claimed ranges "overlap or lie inside ranges discloses 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) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%". The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.) Moreover, the Federal Circuit found that a prima facie case existed where a claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms and the prior art taught that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." In re Geisler, 116 F.3d 1465, 1469-82, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). Therefore, the claimed molar ratio range of dalbavancin to HP-β-CD would have been obvious to one of ordinary skill in the art since the claimed range (i.e., 1:0.6 to 1:2 as recited in instant claim 14; 1:0.6 to 1:1 as recited in instant claim 15; and 1:0.7 to 1:1 as recited in instant claim 16) lies within the prior art molar ratio range of dalbavancin to HP-β-CD (i.e., about 1:0.5 to about 1:5).
With respect to where the formulation further comprises dextrose as recited in instant claim 17, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to modify the teachings of Keser et al. and formulate dalbavancin as a glycopeptide antibiotic in a concentration ranging from 1 mg/ml to 150 mg/ml with HP-β-CD as a cyclodextrin instead of SBE-β-CD, water as a solvent, and dextrose solution as a diluent without the need of a buffer where the molar ratio of dalbavancin to HP-β-CD ranges from about 1:0.5 to about 1:5 and where the pH of the formulation ranges from 2.0 to 6.0 thereby resulting in the rapid dissociation of HP-β-CD after parenteral drug administration, no tissue-irritating effects after intramuscular dosing, no nephrotoxicity, and in superior oral bioavailability of dalbavancin, and such that the inclusion of the cyclodextrin stabilizes the glycopeptide antibiotic for at least about four weeks (1 month) at 25 degrees Celsius in a closed container. One of ordinary skill in the art at the time the invention was made would have been motivated to do so because both SBE-β-CD and HP-β-CD were known to exhibit similar pharmacokinetic properties and used to solubilize and stabilize poorly water-soluble drugs with no nephrotoxic effects as taught by Stella et al.; and because a liquid composition was known to further comprise one or more diluents such as dextrose solution as taught by Keser et al.
One of ordinary skill in the art at the time the invention was made would have had a reasonable expectation of success given that the formulation of Keser et al. comprises a glycopeptide antibiotic in a concentration ranging from 1 mg/ml to 150 mg/ml, a cyclodextrin such as SBE-β-CD, water as a solvent, and one or more diluents without the need of a buffer where the molar ratio of the glycopeptide antibiotic to HP-β-CD ranges from about 1:0.5 to about 1:5 and where the pH of the formulation ranges from 2.0 to 6.0 such that the inclusion of the cyclodextrin stabilizes the glycopeptide antibiotic for at least about four weeks (1 month) at 25 degrees Celsius in a closed container. Therefore, substituting dextrose solution as the diluent, substituting HP-β-CD instead of SBE-β-CD as the cyclodextrin, and substituting dalbavancin as the glycopeptide antibiotic would support the stabilization of dalbavancin antibiotic for at least about four weeks (1 month) at 25 degrees Celsius in a closed container, the rapid dissociation of HP-β-CD after parenteral drug administration, no tissue-irritating effects after intramuscular dosing, no nephrotoxicity, and superior oral bioavailability of dalbavancin by constituting the simple substitution of one known element for another to obtain predictable results and/or some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention and/or the use of known technique to improve similar devices (methods, or products) in the same way and/or the application of a known technique to a known device (method, or product) ready for improvement to yield predictable results pursuant to KSR.
From the 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 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 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 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,070,485 B2 (cited in the IDS received on 6/30/26). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘485 claims:
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(See ‘485 claim 1). As such, the ‘485 aqueous formulation renders obvious the instant aqueous formulation where the ‘485 dalbavancin concentration lies within the instant dalbavancin concentration range, and the molar ratio of dalbavancin to hydroxypropyl beta cyclodextrin and the pH are identical ranges as instantly claimed. Although the ‘485 aqueous formulation precludes the inclusion of a buffer, it is noted that the instant invention does not require a buffer. As such, the negative limitation of ‘485 is encompassed by the instant invention. ‘485 claims 2-3 are identical to instant claims 2-3. ‘485 claims 4-5 are identical to instant claims 6-7 (note: ‘485 claim 4 appears to inadvertently recite 32 mg/ml to 6 mg/ml). ‘485 claims 6-7 are identical to instant claims 9-10. ‘485 claim 8 is identical to instant claim 17. Moreover, the claimed ranges recited in instant claims 12-16 lie inside the ‘485 claimed ranges. Thus, the ‘485 claimed invention is not patentably distinct from the instantly claimed invention.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,729,708 B2 (Keser et al.) in view of Keser et al. WO 2017/194385 A1 published November 16, 2017 (cited in the IDS received on 7/12/24), and Stella et al., Toxicologic Pathol. 36:30-42 (2008) (cited in the IDS received on 7/12/24).
‘708 claims:
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(See ‘708 claims 1, 4, 6-7, 9, and 19 thereby corresponding to issued claims 1-5 and 9, respectively). ‘708 defines a liquid pharmaceutical composition as any liquid form of a formulation no matter if the solvent is one or a mixture of two or more solvents in any suitable concentration where the solvent(s) are selected from water, organic solvents such as PEG, and diluents such as sterile water and dextrose solution (See Keser specification, col. 7, last paragraph to col. 8, 1st paragraph). ‘708 also claims where the organic solvent is ethanol, PEG, or PG or a combination thereof (See ‘708 claim 6), where the composition further comprises an amino acid (See ‘708 claims 7-8). It is noted that the instantly claimed pH lies within the ‘708 claimed pH range, and the instantly claimed molar ratio ranges of dalbavancin to cyclodextrin lies within the ‘708 claimed molar ratio. It is further noted that the ‘708 claimed concentration range of 0.5% to 10% w/V equates to about 5 mg/ml to 100 mg/ml, and thus, the instantly claimed concentration ranges lie within the ‘708 claimed concentration ranges.
However, ‘708 does not specifically claim where the glycopeptide antibiotic is dalbavancin, that the cyclodextrin is HP-β CD, an aqueous sterile formulation, the impurity percentages, and the inclusion of dextrose.
Please see discussion of Keser et al. above along with the motivation to combine the references. Briefly, an ordinary skilled artisan would substitute dalbavancin instead of vancomycin as the glycopeptide antibiotic, HP-β CD instead of SBE-β CD as the cyclodextrin in an aqueous sterile formulation further containing dextrose as an additional solvent with a reasonable expectation of success. Moreover, without evidence to the contrary, the ‘708 claimed liquid pharmaceutical composition would necessarily exhibit the impurity percentages. Therefore, the ‘708 is not patentably distinct from the instantly claimed invention.
Conclusion
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/THEA D' AMBROSIO/Primary Examiner, Art Unit 1654
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