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 . 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.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-14, in the reply filed on 10/27/2025, is acknowledged.
Applicant's election with traverse of (species)
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(lipid soluble side chain, as recited in claim 3); oritavancin (antibacterial agent, as recited in claim 6), in the reply filed on 10/27/2025, is acknowledged.
As no grounds of traversal were specified, the requirement is still deemed proper, and is therefore made FINAL.
Claims 15-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/27/2025.
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claim(s) 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Perkins et al (US 2015/0314002 A1).
Perkins taught oritavancin (an antibiotic) [0005-0006] adsorbed to the surface (reads on the instant claim 1) of lipid based formulations [0067] (e.g., liposomes taught at claim 24), where the antibiotic is complexed with the lipid (reads on the instant claim 2) of the liposome. The structure of oritavancin is (reads on the instant claims 3-6):
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[see Figure 3].
Claim 1 is rendered prima facie obvious over the teachings of Perkins, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results. In the instant case, all the claimed elements (e.g., oritavancin bound to outer surface of liposome) were known in the prior art (e.g., Perkins) and one skilled in the art could have combined the elements as claimed, by known methods with no change in their respective functions; and, the combination would yield nothing more than predictable results (e.g., a liposomal formulation of oritavancin) to one of ordinary skill in the art. MPEP 2143.A.
Perkins reads on claims 1-6.
Claims 7-11 are rendered prima facie obvious because Perkins taught HSPC and cholesterol [0010-0011].
Claim 12 is rendered prima facie obvious because Perkins taught cationic lipids [0068] (e.g., reads on positive surface charge).
Claim 13 is rendered prima facie obvious because Perkins taught a mean particle size of about 0.05 microns (50 nm) to 10 microns (10,000 nm) [claim 24].
The instant claim 13 recites a particle size of 30 nm to 120 nm.
Perkins taught a particle size of 50 nm to 10,000 nm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
As to claim 14, the claim requires a weight ratio of the lipid to the antibacterial agent of 15:1 to 20:1. Perkins taught [0016] a weight ratio of the lipid to the antibiotic of 5:1. It is noted that no surprising effect has been provided in the present application coming from the claimed ratio, if compared with the ratio of Perkins. It is considered that in the absence of any effect linked to such a feature over those known from the prior art, the single structural modification such as variation of amounts (e.g., amounts of liposome lipid and active agent) belongs to common experimental design that a skilled person, who is aware that for the manufacture of liposomes having bound thereon, antibacterial agents, would optimize in routine experiments. In the absence of evidence (experimental comparative data) in the present application showing that the specific weight ratio possesses an unexpected, surprising effect, compared to the ratio known in the prior art, no inventive step can be acknowledged. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of forming liposomes with surface-adsorbed oritavancin have been taught by the prior art; and, as such, it would not have been inventive for the skilled artisan to have discovered the optimum amounts of the liposome lipid and oritavancin, via routine experimentation.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612