DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I, claimed in claims 1-9 in the reply filed on 5/1/26 is acknowledged.
In the reply filed 5/1/26, Applicants amended claims 1-2 and canceled 3-13.
Claims 1-2 are under consideration.
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 (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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Gjoni et al. (WO2020/229369), Cubicin (daptomycin) injection label (accessdata.fda.gov 2011) and CN110339342 (10/18/2019).
Gjoni et al. teach stable daptomycin aqueous pharmaceutical formulation (Abstract). Gjoni et al. teach the stable daptomycin for injection [182]. Gjoni et al. teach the formulation comprises calcium in the form of calcium chloride [028,062,155]. Gjoni et al. teach the calcium is present in a molar ratio to daptomycin of 0.1:1 to 2:1 [028]. Gjoni et al. teach the pH can be adjusted using pH adjusters known in the art, for example sodium hydroxide [067]. Gjoni et al. teach the formulation can be diluted in sodium chloride [181]. Gjoni et al. teach that daptomycin is approved by the FDA for treatment of infections caused by gram-positive pathogens [004], meeting the limitation “for treating injections caused by Gram-positive bacteria”. Furthermore, the limitation “for treating a respiratory tract infection" is regarded that "intended use" of a composition or product will not further limit claims drawn to a composition or product. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In Re Hack 114, USPQ 161. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation. In the instant case the prior art teaches daptomycin is capable of performing the intended use.
Gjoni et al. does not teach an example of daptomycin comprising sodium chloride or a pH of 4.5. However, the teachings of Cubicin injection label and CN110339342 cures this deficiency.
Cubicin injection label teaches daptomycin with 0.9% sodium chloride (p. 3-5, 17). Cubicin injection label further teaches that daptomycin formulation include sodium hydroxide for pH adjustment (p. 17). Cubicin teaches that
CN110339342 teaches and claims a composition comprising daptomycin with a pH of 4-8 (claims 10, 13 and 14; middle of p. 3).
With respect to claim 1, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the daptomycin formulation of Gjoni et al. to include sodium chloride as taught by Gjoni and Cubicin and to adjust the pH to 4.5 as taught by CN110339342 in order to create a pharmaceutically stable daptomycin formulation. One of ordinary skill in the art would have been motivated to optimize and combine these known variables to obtain a stable daptomycin formulation suitable for pharmaceutical use. There is a reasonable expectation of success because the references teach conventional formulation components and conditions which are known components in daptomycin formulations.
The molar ratios of daptomycin to calcium chloride to sodium chloride is a result-effective variable and the determination of the optimum or workable ranges of said variable maybe characterized by routine experimentation (Please see MPEP 2144 II-Optimization of Ranges). In the instant case, Gjoni et al. teach the calcium is present in a molar ratio to daptomycin of 0.1:1 to 2:1 [028]. It would have been obvious and routine experimentation to a person of ordinary skill in the art with a reasonable expectation of success to optimize the molar ratios of the components because the prior art recognizing the components affect pharmaceutical formulation properties and stability. Therefore, it would have been obvious to arrive at the molar ranges of claim 1.
With respect to claim 2, CN110339342 claims the daptomycin is freeze-dried or spray-dried (claim 4).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TARA L MARTINEZ whose telephone number is (571)270-1470. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/TARA L MARTINEZ/ Examiner, Art Unit 1654
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