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 .
Summary
Claims 1 – 18 and 23 - 30 are pending in this office action. Claims 19 - 22 have been cancelled. All pending claims are under examination in this application.
Priority
The current application filed on November 18, 2024, is a 371 of PCT/GB2023/051331, filed May 19, 2023, which in turn claims priority to British patent application GB2207345.6 filed on May 19, 2022.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on February 18, 2025 is acknowledged. A signed copy of each of the forms PTO/SB/08 is attached to this office action.
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 25 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.
The term, “suitably” is not understood. What makes a glass via suitable and what makes a multiple dose vial suitable?
Examiner recommends either canceling the claim or removing the indefinite term.
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.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claims 1-6, 12 – 16 and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Palepu WO 2014194296 A1, published 2014-12-04 in view of Zhu et al. CN 112315904 A, published 2021-02-05. Note that these are the same references the European examiner cited but named for the first inventor, not the assignee.
Palepu teaches stabilized vancomycin solutions comprising lactic acid, polar solvent such as propylene glycol and a pH adjuster to set the pH to 3-8, see abstract.
On page 2, lines 11-14 they disclose amounts of vancomycin to be 25 mg/mL to about 150 mg/mL and from about 2.5 mg/mL to about 15 mg/mL These amounts read on those in instant claims 1 and 2.
The lactic acid can be the DL form, the D form or the L form, see page 6, lines 18-19. The concentration of lactic acid is taught to be from about 0.25M to about 1.5M, 0.5M to about 1.25M or from about 0.75M to about 1M; these amounts read on those in instant claims 3 and 4.
The polar solvent (cosolvent) comprises propylene glycol, polyethylene glycol, or mixtures thereof (page 2, lines 6 and 7); they mention amounts from 25-50% at page 6, lines 26-28.
They use sodium or calcium hydroxide as pH adjuster at an amount sufficient to maintain a pH of 3-8 or 4-6, for example. While Palepu does not disclose the exact amounts, because the pH is similar to that claimed, the amount of hydroxide would necessarily have to be present in similar amounts.
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date, to prepare a stable vancomycin solution that contains lactic acid and propylene glycol as well as an inorganic salt since Palepu teaches to do so.
With regard to claims 23, 24 and 26, Palepu discloses preparation by dilution and storing in a glass vial, multiple dose vials are a subset of glass vial. It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date, to follow the teachings of Palepu to prepare the composition by dilution and put it into a glass vial.
With regard to claims 13-15 and 26, Palepu teaches using 0.9% sodium chloride in the dilution liquid, one of ordinary skill in the art would be motivated to follow suit.
Claims 7-11, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Palepu WO 2014194296 A1, published 2014-12-04 in view of Zhu et al. CN 112315904 A, published 2021-02-05 as applied to claims 1-6, 12, 13, 14 and 23-26 above, and further in view of Geibel WO 2015153552 A1, published 2015-10-08.
Palepu and Zhu et al. do not teach the claimed glycerol.
Geibel teaches methods of increasing pH of gastric juices that include administration of a comp comprising Zn salt, glycopeptide antibiotic such as vancomycin and a stabilizer that is chosen from ethanol, glycerin, propylene glycol, polyethylene glycol and their mixtures. Stabilizer is present at least about 10% by weight of the composition. See claims 124, 125, 127, 129.
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date, to use the combination of propylene glycol and glycerin (different name for glycerol) in order to help stabilize a vancomycin solution because Geibel teaches that combination as a stabilizer. The specific amounts and ratios are not taught but said person of ordinary skill would be able to follow the teachings of Palepu and adapt them to the combined cosolvent composition with.
Claims 27 - 30 are rejected under 35 U.S.C. 103 as being unpatentable over Palepu WO 2014194296 A1, published 2014-12-04 in view of Zhu et al. CN 112315904 A, published 2021-02-05 as applied to claims 1-6, 12, 13, 14 and 23-26 above, and further in view of Levine.
Palepu and Zhu et al. hint at killing bacteria with vancomycin.
Levine teaches some bacteria that are killed by vancomycin; many are included in claim 28. It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date, to use the stabilized formulation of Palepu in view of Zhu et al. to kill those bacteria with the reasonable expectation of success.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Chen WO 2016127087 A1, published 2016-08-11 teaches stabilized vancomycin solutions comprising an acid such as lactic acid, inorganic salt such as sodium chloride and potassium chloride and glycerol. does not teach propylene glycol.
Palepu et al. WO 2017123912 A1, published 2017-07-20 teach stabilized vancomycin comprising glycerol and lactic acid and optionally d) a pH adjustor, in an amount sufficient to maintain a pH of the vancomycin-containing composition at from about 4.5 to about 7.5, and in some aspects preferably at about 5.5 or 6.5. Vancomycin is preferably present in the formulation as an HCl salt. The level of lactate can derive from any enantiomeric form or mixture of enantiomeric forms of lactic acid or its salts such as D, L or preferably DL. The composition also comprises a pharmaceutically acceptable fluid such as 0.3% sodium chloride. Claim 9 states that the liquid vancomycin-containing composition of claim 1, wherein the pharmaceutically acceptable fluid comprises from about 0.25 M to about 1.0 M lactic acid.
Keser et al. WO 2017194385 A1, published 2017-11-16 teach liquid formulations of glycopeptide antibiotics such as Vancomycin (as HCl salt) that include a glycol such as propylene glycol.
Japanese application JP2008201778A discloses aqueous Vancomycin preparations with addition of glycerol and D-alanine or DL-alanine and/or D-lactic acid or DL-lactic acid.
Conclusion
No claim is allowed.
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/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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